Fellowship Programs
Howard University College of Pharmacy Fellowship Programs
Howard University College of Pharmacy Pharmaceutical Industry Post Doctoral fellowship program exists to recruit and develop candidates of promise, with a particular focus on African American and other ethnically diverse persons who have a demonstrated history of excellence; possess excellent written and oral communication; are coachable and possess the raw leadership material necessary for C-suite consideration.
We currently host twelve partners representing more than 32 post-doctoral fellowship slots as we build tomorrow's Pharmaceutical Industry leaders.
Application Requirements
Submit the combined application packet to Earl.ettienne@howard.edu
Please use the subject line: (company name/Howard Fellowship Application
*Interviews are conducted on a rolling basis, interested candidates may submit their supporting materials no later than 11/22/2022.
Eligibility Criteria:
• Graduated or will graduate with PharmD from an Accredited School or College of Pharmacy.
• Candidates must hold a degree as of July 1st of the Fellowship term.
Deadlines:
• Letter of Intent - Due Date 11/22/2022
• Curriculum Vitae - Due Date 11/22/2022
•3 Letters of Recommendations - Due Date 11/22/2022
• Official Transcript - Due Date 11/30/2022
Please Note: We continue to recruit for all Genentech and Sanofi positions. We will fill them on a rolling basis but would like to have all applications in by 12/31/22.
Sanofi- Howard Research Opportunities
Immuno-Oncology Cell Therapy Cluster-Global Oncology Research
Overview:
Cancer is the second leading cause of death globally. At Sanofi, we believe in a world in which the combination of ground-breaking science, AI and novel technologies brings a new wave of therapies for areas of high unmet need. We are strongly investing in new partnerships and acquisitions to spur rapid innovation. That’s why we are looking for bold and ambitious scientists to join our Oncology Research Department in our mission to restore hope for people living with cancer. Our department is divided into multiple clusters, each working relentlessly to identify and validate new first-in-class, best-in-class molecules or therapeutic modalities to address high unmet medical needs as well as extend our understanding of biology and immunology of cancer, how the current medications work through dedicated research studies to maximize the value of our drugs in approved indications.
Specifically, we re-engineer immune cells to adaptively transfer to patients to selectively kill the tumor cells. Immune cells will function as living drugs and, in favorable situations, expand and exert a robust anti-tumor response. Similarly, they are bound by the same laws that endogenous human cells are, such as exhaustion by tumor-produced factors, abnormal tumor vessels, and other obstacles that a suppressive tumor microenvironment poses. We try to remove barriers to the success of cell-based therapies in our group.
Goal:
We will provide a supportive environment for the fellow to learn about potential career paths in Research function in a pharmaceutical setting. A comprehensive training program is set in place to train the fellow hands-on in the lab in conducting experiments designed to ask a fundamental biological question on how the tumor microenvironment (TME) exerts immunosuppression on cell-based therapies and how we can alleviate the immunosuppression.
Objectives:
- Support existing therapeutic programs by developing assays and techniques to mimic the tumor microenvironment to test antibodies and biomaterials (e.g., nanoparticles) that alter the immune system in favor of tumor cell eradication.
- Learn how within a therapeutic area a project is developed and moves through stages of drug development, and how to be effective in a highly organized large pharma
- Develop proficient interpersonal and communication skills when interacting with key stakeholders.
- work on multiple assignments under one deliverable outcome, and effectively document scientific data to move projects forward and impactful scientific publications.
Sanofi component:
- Develop research and communication skills: The fellow will get hands-on training in experimental design, execution, as well as data evaluation to build impactful preclinical research studies. The fellow will also strengthen both verbal and written communications through the preparation and presentation of scientific data as global talks, international conferences, and impactful scientific publications.
- Leadership: Over the course of preceptorship, the fellow will learn to lead the project and interact and align with key stakeholders to drive the direction of the project.
- Innovation: The fellow will learn and explore innovative technologies (e.g., system biology approaches and drug delivery) in Sanofi and potentially incorporate them into the research project to build our understanding of mechanisms through which we can alleviate immunosuppression in tumors to potentiate immunotherapy
- Networking: The fellow will have extensive opportunities to interact with Sanofi colleagues in various functions within research and development and medical affairs, as well as other fellows and post-docs to find support and drive career development.
Ideal candidate:
A PharmD with a passion for cancer research and drug development having all of some of these skill sets:
- Advanced knowledge of therapeutics
- Working knowledge of biology
- Strong technical/analytical skills to identify and solve problems
- Proven ability to work with a high level of integrity, accuracy, and attention to detail
- Strong organizational skills in order to maintain a high level of productivity to complete assignments on-time
- Scientific writing and presentation skills as excellent oral and written communication skills are required for effectively interfacing with all members of the company
- Self-motivated, enthusiastic, and results-oriented
Location:
Cambridge, MA
Rare or Neurological Disease TA
Overview:
The Rare and Neurological Therapeutic Area research group is working on understanding diseases with large unmet medical need and bringing the next wave of therapies to patients. We employ cutting edge approaches to try to better elucidate key interventional nodes in diseases like ALS, Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis.
Goal:
Sanofi is seeking a curious and motivated fellow to support disease biomarker discovery efforts in the Neuroinflammation Cluster within the Rare and Neurological Disease research group. You will help Sanofi uncover robust biomarker signatures associated with disease through the integration of diverse in-house and external omics datasets. This will also support a stronger understanding of disease signatures and targets. In utilizing these approaches, the goal for fellow joining is to train the individual in various aspects of drug discovery and drug development in a high paced setting.
Objectives:
A key objective for this project will be to utilize the large human specific data sets that our group has generated across different diseases and to identify common nodes in neurodegeneration. These hypotheses will then be tested in both in vitro and in vivo settings to identify novel targets and biomarkers.
Sanofi component:
The fellow will be exposed so several aspects of drug target and discovery validation in our early research pipeline across multiple diseases and will contribute to project team in later stage development projects like RIPK1, BTK, and aCD40L for MS and ALS. The goal is to generate a playbook for future reverse translation efforts in the group.
Ideal candidate:
We are looking for a highly qualified and motivated scientist to join the precision neurology and neuroinflammation cluster, focused on discovering, validating, and developing therapies for rare neurologic and neurodegenerative diseases. This position will combine computational analysis of omics and clinical data as well as laboratory work. The ideal candidate will be responsible for working individually and as part of a team to design and execute experiments.
Location:
Cambridge, MA
I&I TA – in Type 2 & Dupixent Research Cluster
Overview:
The Immunology and Inflammation Therapeutic Area in Sanofi is composed of a world-class immunology team that is aiming to deliver medicine to transform the lives of patients in the fields of Type 2 Immunity and Dupixent, Complement Biology, Immune Checkpoint Biology, Targeted Autoimmunity and Type 1 Diabetes, and Type 1 & 17 Immunity. We work relentlessly to identify and validate new first-in-class, best-in-class molecules to address highly unmet medical needs as well as extend our understanding of current medications through dedicated research studies to maximize the value of our drugs in approved indications.
Goal:
Our team provides a supportive environment for the fellow to gain insight into potential career paths in Research function in a pharmaceutical setting. The fellow will acquire hands-on experience using in vitro and in vivo immunological skills with state-of-the-art technologies to execute preclinical research work and enhance our understanding of type 2 inflammation.
Objectives:
- Support an exciting research project, working closely with scientists in the group to establish assays to advance our knowledge of interactions between mast cells and other cell types that contribute to type 2 inflammatory diseases.
- Learn how different functions contribute to drug research and development journey and how to be effective in a highly matrixed organization.
- Develop proficient interpersonal and communication skills when interacting with key stakeholders.
- Enable a deep and broad learning experience of drug discovery journey from early discovery research to post-approval of a drug by attending seminars and meetings.
Sanofi component:
- Develop research and communication skills: The fellow will get hands-on training in experimental design, execution, as well as data evaluation to build impactful preclinical research studies. The fellow will also strengthen both verbal and written communications through preparation and presentation of the scientific data.
- Leadership: Over the course of preceptorship, the fellow will learn to lead the project and interact and align with key stakeholders to drive the direction of the project.
- Innovation: The fellow will learn and explore innovative technologies including omic approaches in Sanofi and potentially incorporating them into the research project to build our understanding of type 2 inflammation.
- Networking: The fellow will have extensive opportunities to interact with Sanofi colleagues in various functions within research and development and medical affairs, as well as other fellows and post-docs to find support and drive career development.
Ideal candidate:
- The ideal candidate for this fellowship will have some research experience and be curious and eager to learn laboratory skills to advance our mechanistic biological understanding of type 2 inflammation.
- The candidate should possess ability to work effectively both independently and collaboratively and have strong organization, communication, presentation, and interpersonal skills.
Location:
Cambridge, MA
Drug Metabolism and Pharmacokinetics- DMPK Platform US
Overview:
The Drug Metabolism and Pharmacokinetics (DMPK) US Platform is responsible for determining the disposition, safe starting dose and predicted efficacious dose prior to first in human clinical trials. To achieve this DMPK scientists run preclinical in vivo and in vitro experiments to understand the absorption, distribution, metabolism, and excretion properties of drug development candidates. Additionally, in conjunction with pharmacology teams, DMPK scientists will design and interpret pharmacokinetic/pharmacodynamic (PKPD) studies to understand the relationship between drug concentration and pharmacologic effect and predict efficacious doses. DMPK is also responsible for developing robust bioanalytical assays that allow for an accurate quantitation of development candidates in biological matrices.
Goal:
To develop skills related to DMPK sciences and contribute to the overall deliverables of the department.
Objectives:
Objectives to be tailored to candidates’ skills/interests but could potentially include:
- Designing/conducting/outsourcing in vivo pharmacokinetics and/or in vitro metabolism/drug interaction studies
- Analyzing/interpreting and reporting results
- Developing and running bioanalytical assays
- Writing pharmacokinetics reports
- Conducting PKPD analysis
Sanofi component:
Provide training and mentorship to achieve above goals and objectives.
Ideal candidate:
- Highly motivated
- Strong organizational and communication skills
- Background in pharmacokinetics, drug metabolism, molecular biology, bioanalysis or modeling and simulation
Location:
Cambridge, MA
Clinical Development – Immunology and Inflammation
Overview
Sanofi scientists and physicians are committed to helping people who are suffering from immune-mediated diseases that have long eluded treatment. These treatments are evaluated in Global Clinical Development which encompasses clinical drug development programs that are executed by multi-disciplinary teams in the Therapeutic Areas (TA). The TA of Immunology & Inflammation (I&I) is one of the most active areas in Sanofi with many products in development including our flagship medicine, Dupixent. In I&I, we translate drug biology to disease
biology to develop the data that affords understanding of drug impact on disease pathogenesis and safety. We also define the target product profile (TPP) and target value proposition (TVP) together with Commercial, build the project development strategy and plan, and generate and execute the development plan. For our clinical studies, we provide relevant clinical documents (i.e., protocols, informed consents, etc), ensure appropriate medical supervision of clinical trials, develop global submission plans, and orchestrate interaction with global health authorities. We communicate evidence from our studies through scientific journals and congresses together with Medical Affairs. All of these activities require engagement with internal governance and management of key internal and external stakeholders.
Goal
Develop the fellow into a clinical development leader with a broad understanding of the drug development process.
Objectives
- Serves on a cross functional drug development team focused on the development and implementation of the program-specific strategy.
- Supports the Clinical Research Director (CRD) in clinical science aspects of the program and assists the CRD for creation of the clinical development plan (CDP) at all stages of the program taking in key inputs from other functions, e.g., biostats, clinical pharmacology, operations, etc.
- Supports the preparation of clinical and other data for governance and other presentations.
- Follows developments and trends in the medical & scientific literature and disseminates updates to the project team and beyond.
- Where required, leads project specific reviews of the competitor landscape to inform the program strategy.
- Provides scientific input on current state of disease area, other compounds in development, new insights on pathogenesis.
- Prepares and publish data in peer reviewed journals.
Sanofi component
Understanding of the drug development process: As a member of the clinical development team, the fellow will gain expertise in the drug development process, including both the strategic and operational components of clinical research.
Leadership to create impact: Over time, the fellow will have an opportunity to lead initiatives to help build the strategy of the drug program. These areas may include assessment of the scientific evidence, evaluation of the competitive landscape, and data review/analysis.
Develop study level skills: The fellow will get hands on training in study design, protocol writing, data evaluations, and safety monitoring, amongst others. The fellow will be expected to perform medical reviews
under the supervision of the CRD.
Communication and external engagement: The fellow will work on both written and verbal communications through the preparation and presentation of materials. The fellow will represent Sanofi as a support team member for external meetings such as Congresses, Advisory Boards and Investigator Meetings. The fellow interacts with Key Opinion Leaders in the field in order to the develop protocol, choose investigators, etc.
Ideal candidate
- PharmD, Biomedical Ph.D., or relevant Clinical degree
- A good understanding of the pharmaceutical and clinical drug development process; if no experience, enthusiasm and openness to learn
- Ability to work both independently and cross functionally within a team environment
- Ability to problem solve and manage issues with a solution focused approach
- Strong collaborative communications skills including the ability to engage with a diverse internal and external client base and find ways to manage through conflict
- Agility in the application of new digital solutions
- Must have permanent US work authorization
Location:
Washington DC
Sanofi- Howard Development Opportunities
Biomarkers and Clinical Bioanalyses (BCB)
Overview:
BCB is a global department within the Translational Medicine and Early Development group focused on the translation of research projects into nonclinical and clinical development. BCB functions as a regulated laboratory responsible for the implementation of bioanalytical methods used for the analysis of biomarkers, pharmacokinetics, and immunogenicity and supports programs from early development in non-clinical species through FDA approval. The BCB fellowship will provide the fellow with training and hands on experience in the development and implementation of methods to support regulatory submissions.
Goal:
To provide the fellow with exposure to the drug development pipeline through the perspective of bioanalysis. Upon successful completion of the program, the fellow will have gained considerable experience with ligand binding assays in a regulated environment in the setting of an innovative R&D organization in a large biopharmaceutical company.
Objectives:
- In the initial months, the fellow will be introduced to laboratory techniques through intensive hands-on training in different immunoassay platforms. Additionally, the fellow will learn the regulatory requirements of nonclinical and clinical development.
- The fellow will lead a nonclinical or clinical program while being closely mentored by a staff member and gain hands-on experience in nonclinical or clinical development.
- The fellow will attend cross-functional meetings to ensure a deep and broad learning experience.
- The fellow will better understand the impact and contribution of bioanalysis to patient safety.
- The fellow will gain exposure to different therapeutic areas such as oncology, immunology, and rare diseases.
- The fellow will learn how to be effective in a highly matrixed organization.
Sanofi component:
- Understanding the early drug development process: How does a bio-pharmaceutical company proceed from the toxicology studies in animals to give an experimental medicine to a healthy volunteer or patient for the first time? How is the dose chosen? How is safety ensured? What are the details of proceeding to early clinical studies? The fellow will learn essentials of translational medicine and early development.
- Teamwork/Leadership: The fellow will work in a dynamic team setting, in which collaboration is key. The fellow will have the opportunity to lead one or more aspects of selected projects.
- Communication: For the teams to be effective, communication is critical. The fellow will participate in various meetings essential to the early drug development process. The fellow will have the opportunity to present their work, with guidance from their mentor so that the fellow can optimize their communication skills.
- Networking: The fellow will have extensive opportunity to interact with Sanofi staff in various disciplines, as well as the other fellows.
- Innovation: The fellow will learn how Sanofi is exploring new bioanalytical techniques to bring medicine to patients faster. The fellow is encouraged to make proposals for additional innovations based on their experience in pharmacy training – great ideas come from multiple sources.
Ideal candidate:
- PharmD degree
- Prior experience in laboratory techniques, with a deep interest in working in a bioanalytical lab to bring medicines to patients.
- Demonstrated scientific expertise with keen analytical skills to assess the results of laboratory experiments.
- Demonstrated effective communication skills. Skillfully plans, prioritizes, and executes multiple responsibilities.
- A desire to learn in a dynamic environment while also making individual contributions. Robust interpersonal skills and ability to work cross-functionally.
Location:
Cambridge, MA
Clinical Development – Immunology and Inflammation
Overview
Sanofi scientists and physicians are committed to helping people who are suffering from immune-mediated diseases that have long eluded treatment. These treatments are evaluated in Global Clinical Development which encompasses clinical drug development programs that are executed by multi-disciplinary teams in the Therapeutic Areas (TA). The TA of Immunology & Inflammation (I&I) is one of the most active areas in Sanofi with many products in development including our flagship medicine, Dupixent. In I&I, we translate drug biology to disease
biology to develop the data that affords understanding of drug impact on disease pathogenesis and safety. We also define the target product profile (TPP) and target value proposition (TVP) together with Commercial, build the project development strategy and plan, and generate and execute the development plan. For our clinical studies, we provide relevant clinical documents (i.e., protocols, informed consents, etc), ensure appropriate medical supervision of clinical trials, develop global submission plans, and orchestrate interaction with global health authorities. We communicate evidence from our studies through scientific journals and congresses together with Medical Affairs. All of these activities require engagement with internal governance and management of key internal and external stakeholders.
Goal
Develop the fellow into a clinical development leader with a broad understanding of the drug development process.
Objectives
- Serves on a cross functional drug development team focused on the development and implementation of the program-specific strategy.
- Supports the Clinical Research Director (CRD) in clinical science aspects of the program and assists the CRD for creation of the clinical development plan (CDP) at all stages of the program taking in key inputs from other functions, e.g., biostats, clinical pharmacology, operations, etc.
- Supports the preparation of clinical and other data for governance and other presentations.
- Follows developments and trends in the medical & scientific literature and disseminates updates to the project team and beyond.
- Where required, leads project specific reviews of the competitor landscape to inform the program strategy.
- Provides scientific input on current state of disease area, other compounds in development, new insights on pathogenesis.
- Prepares and publish data in peer reviewed journals.
Sanofi component
Understanding of the drug development process: As a member of the clinical development team, the fellow will gain expertise in the drug development process, including both the strategic and operational components of clinical research.
Leadership to create impact: Over time, the fellow will have an opportunity to lead initiatives to help build the strategy of the drug program. These areas may include assessment of the scientific evidence, evaluation of the competitive landscape, and data review/analysis.
Develop study level skills: The fellow will get hands on training in study design, protocol writing, data evaluations, and safety monitoring, amongst others. The fellow will be expected to perform medical reviews
under the supervision of the CRD.
Communication and external engagement: The fellow will work on both written and verbal communications through the preparation and presentation of materials. The fellow will represent Sanofi as a support team member for external meetings such as Congresses, Advisory Boards and Investigator Meetings. The fellow interacts with Key Opinion Leaders in the field in order to the develop protocol, choose investigators, etc.
Ideal candidate
- PharmD, Biomedical Ph.D., or relevant Clinical degree
- A good understanding of the pharmaceutical and clinical drug development process; if no experience, enthusiasm and openness to learn
- Ability to work both independently and cross functionally within a team environment
- Ability to problem solve and manage issues with a solution focused approach
- Strong collaborative communications skills including the ability to engage with a diverse internal and external client base and find ways to manage through conflict
- Agility in the application of new digital solutions
- Must have permanent US work authorization
Location:
Washington DC
Clinical Sciences and Operations
Overview:
The Clinical Sciences and Operations (CSO) platform is responsible for the planning, execution, and reporting of clinical trials at Sanofi. Running trials to specific timelines, within budget, and to rigorous quality standards requires teams of dedicated associates playing a plethora of functional roles, including: medical writers, trial managers, clinical scientists, medical advisors, and supply chain managers. During the first year, the fellow will be given the opportunity to contribute to study teams in a number of roles before focusing on one area for their second year.
Goal:
Provide the fellow with insight into potential career paths in clinical development while providing opportunity to contribute to one or more clinical study teams.
Objectives:
- Develop an understanding of how the various functions contribute to a clinical study team.
- Learn how to be effective in a highly matrixed organization, as well as manage vendors.
- Become familiar with clinical study documentation (e.g., protocols, investigator brochure, informed consent form); how they are designed, written, and distributed during the course of a study.
- Contribute to a study feasibility assessment, taking into account the site, and patient perspective.
- Use multiple sources of data to build and/or manage a study budget.
- Contribute to the construction of an operational plan including supply chain management strategy.
- Become familiar with the quality and regulatory standards expected of our study teams.
- Partner with CSO to implement clinical trial diversity strategy.
Sanofi component
Leadership/Teamwork: The fellow will gain experience working in an international, multicultural team setting. The fellow will demonstrate independent thinking and develop leadership skills to challenge the status quo within the team.
Networking: The fellow will build an extensive network internally because of our team-centric approach. Additionally, there will also be opportunities to interact with patients, research sites, vendors, and key opinion leaders.
Communication: There will be significant opportunities to develop communication skills through presenting at multiple forums, including study team meetings, investigator meetings, and department meetings.
Innovation: Clinical operations is a dynamic, rapidly evolving environment with opportunities to implement new digital technologies
that will reduce the burden on the patient and study sites. The fellow will be encouraged to propose and/ or pilot new approaches to clinical development.
Ideal candidate:
The ideal candidate for Clinical Sciences and Operations should have:
- Effective communication skills to facilitate cross functional teamwork within Clinical Sciences and Operations
- Independent thinking to optimize the efficiency of clinical operations
- Flexibility to adapt to changes in a dynamic working environment
Location:
Bridgewater, NJ
CSU-SPM (site partnership manager)-Role to support many site and patient engagement activities as we build D&I strategy
Overview:
The Clinical Sciences and Operations (CSO) platform is responsible for the planning, execution, and reporting of clinical trials at Sanofi. Running trials to specific timelines, within budget, and to rigorous quality standards requires teams of dedicated associates playing a plethora of functional roles, including medical writers, trial managers, clinical scientists, medical advisors, and supply chain managers.
The Clinical Study Unit (CSU) is the country level operations arm of CSO. The CSU is a strategic function driving the end-to-end integration of our asset development by:
- Delivering studies & securing business continuity plans,
- Shaping the external environment and engaging our investigators and patients,
- Aligning the communication of the medical, digital and product strategic ambition of Sanofi in the delivery of our clinical programs,
- Supporting local market preparation, enhancing company reputation.
Goal:
Provide the fellow with insight into potential career paths in clinical development while providing opportunity to contribute to the US CSU DICT strategy.
Objectives:
- Develop an understanding of how the various functions contribute to a clinical study team.
- Learn how to be effective in a highly matrixed organization, as well as manage vendors.
- Become familiar with clinical study documentation (e.g., protocols, investigator brochure, informed consent form); how they are designed, written, and distributed during a study.
- Contribute to a study feasibility assessment, taking into account the site, and patient perspective.
- Become familiar with the quality and regulatory standards expected of our study teams.
- Partner with CSO to implement clinical trial diversity strategy to ensure historically underrepresented communities are included in clinical trials
Sanofi component:
Leadership/Teamwork: The fellow will gain experience working in an international, multicultural team setting. The fellow will demonstrate independent thinking and develop leadership skills to challenge the status quo within the team. Networking: The fellow will build an extensive network internally because of our team-centric approach. Additionally, there will also be opportunities to interact with patients, research sites, vendors, and key opinion leaders. Communication: There will be significant opportunities to develop communication skills through presenting at multiple forums, including study team meetings, investigator meetings, and department meetings. Innovation: Clinical operations is a dynamic, rapidly evolving environment with opportunities to implement new digital technologies that will reduce the burden on the patient and study sites. The fellow will be encouraged to propose and/ or pilot new approaches to clinical development.
Ideal candidate:
- Graduate of an Accreditation Council for Pharmacy Education (ACPE) accredited Doctor of Pharmacy Program prior to the start of the fellowship 2-year term
- Interested in pursuing a career in the pharmaceutical industry
- Eligible to work in the United States
- The fellowship programs will select PharmD graduates from Howard University. The PharmDs will work within CSO for two years. During this time, the fellows will rotate within various departments to get a glimpse into drug development. These rotations will include Diversity and Inclusion in Clinical Trials, Trial Operations, the Clinical Study Unit, Medical Writing, and Clinical Supplies.
- Eager to improve access to health care for underrepresented communities.
- Interest in developing communities and employee engagement
Committed to upholding ethics and transparency addressing environmental challenges
Location:
Bridgewater, NJ,
Washington DC,
Cambridge, MA
R&D North America- Operations
Overview:
Are you passionate about chasing the miracles of science to improve people’s lives and helping create the leading biopharmaceutical R&D organization in North America? At Sanofi, the purpose of the Global Operations team is to provide an exciting, leading and supportive environment for our people to maximize the value of our pipeline and bring transformative drugs with pace to patients. In NA R&D Operations we support R&D teams with processes and tools, knowledge and collaborative networks to ensure best-in-class implementation of our project strategies and maximize the engagement of our people across all our sites.
Goal:
The Global Operations team provides and leads a supportive environment for our people to maximize the value of our pipeline and bring transformative drugs to patients. R&D North America Operations supports R&D teams with processes and tools, knowledge, and collaborative networks to ensure best-in-class implementation of our project strategies and maximize engagement of people across all sites. The program goal is to provide the Fellow with the experience and opportunities to interact with multi-disciplinary teams in driving projects that enable R&D Operations and programs across North America.
Objectives:
- Develop R&D operations portfolio, project, and data management skills.
- Obtain experience in understanding user needs and design thinking methodologies, relevant data processing and presentation/visualization to drive continuous improvement.
- Obtain insight on how to connect different sources of data and gain insight across multiple R&D groups/ functions.
- Develop proficient communication skills when interacting with internal and external stakeholders.
- Become knowledgeable of current Biopharma and scientific trends.
Sanofi component
- Contribute to simplification and continuous improvement of R&D processes. The fellow will work with cross functional groups and colleagues to help implement and design solutions that bring simplicity and user friendliness to complex business challenges to drive efficiency, productivity for R&D processes.
- Change Management/ Teamwork/ Leadership. The fellow will actively lead or contribute to change management and future of scientific work projects and/or activities within R&D NA team. In addition, the fellow will support multidisciplinary teams that may include various therapeutic areas and external stakeholders.
- Assist in data management activities and dashboarding. The fellow will prepare various dashboards and data sets pertaining to R&D NA Operations portfolio of projects. The fellow will evaluate various technological approaches and tools as an expert user and aid in prioritizing and selecting the right tool in partnership with our Digital organization.
- Contribute to external ecosystem leadership meetings. The fellow has the opportunity to contribute to the preparation and execution of leadership meetings including developing content and briefing packages, organizing internal meetings with external stakeholders, and taking minutes for external meetings to drive the external ecosystem engagement plan.
- Become an integrated part of R&D NA Operations team. The fellow will learn how to apply and implement advanced technological approaches, user centricity, tools and strategies to improve project and process efficiency and ways of working.
- Networking. The fellow will enhance their influencing, negotiation, change management and leadership skills.
Ideal candidate
The ideal candidate for this fellowship has the desire to learn the skills needed to develop streamlined and user centric approaches and strategies to improve process efficiency and ways of working. The candidate should be eager to learn about change management, transformation, portfolio management, user centric design, use of digital tools and how to evaluate them in developing a strategic plan. Dynamic candidates with a passion for organizational culture, project and portfolio management, collaborative engagement with multiple stakeholders, data science, and strong independent work ethic are encouraged to apply.
Location:
Cambridge, MA
Global Regulatory Affairs- Specialty Care
Overview:
Sanofi's global specialty care business unit focuses on rare diseases, rare blood disorders, neurology, immunology, and oncology. Sanofi's ambition is to leverage science and innovation to improve people’s lives and be the industry leader in immunology and oncology. Its approach is shaped by a long history of developing highly specialized treatments and forging close relationships with physician and patient communities.
Goal:
Gain hands-on experience across a variety of specialties within the Global Regulatory Affairs department. Develop a well-rounded understanding of the regulatory functions and drug development process from early stage to postmarketing. Lead team meetings, develop regulatory strategy, and contribute to and lead Health
Authority submissions with increasing responsibility throughout the Fellowship program.
Objectives:
- Develop regulatory strategic skills while contributing to global pre- and post-approval planning and submissions.
- Partner with Medical, Legal, Marketing, and Safety in delivering products for diseases globally.
- Gain experience in the review and approval of promotional materials, including effective feedback skills.
- Opportunity to engage with global colleagues and learn country/region-specific regulatory processes.
- Develop strong communication and project management skills of our study teams.
Sanofi component:
The Global Regulatory Affairs Specialty Care fellowship program will allow the individual to explore and understand the broad remit of the Global Regulatory Team Lead (GRTL) role at Sanofi.
The fellow will be following a development plan with given exposure and project driven experiences working on different therapeutic modalities at various stages of clinical development, to develop the tactical and strategic
capabilities needed to be a successful regulatory professional.
Ideal candidate:
The ideal candidate would have received a PharmD from an accredited US Pharmacy School and have excellent written and verbal communication skills and basic science/clinical research or industry experience relevant to the therapeutic area where they will be working.
Location:
Cambridge, MA
Abbvie Pharmaceuticals Medical information Fellowship Program
Program Overview
This 12-month Medical Information Fellowship Program is designed to provide recent Pharm.D., MD, Ph.D., or equivalent advanced degree graduates an opportunity to learn the skills and experiences to excel in Medical Information, a key function in any Medical Affairs organization across the pharmaceutical industry. The fellowship is based in Irvine, California. The Participant will be an integral part of the Global Medical Information team and will develop/manage Medical Information content used to respond to requests for information about Allergan’s products. The overall goal is to provide an opportunity for the Participant to learn the skills necessary for a successful career in the pharmaceutical industry with an emphasis in Medical Information.
ABBVIE: Who We Are
We’re focused on sustainable growth and addressing the world’s pressing health challenges. Our mission is to create an innovation-driven, patient-focused specialty biopharmaceutical company capable of achieving sustainable top-tier performance through outstanding execution and a consistent stream of innovative new medicines. Innovative medicines provide compelling patient benefits, differentiated clinical performance, and economic value. Building on our market leadership, we will continue to bring our promoted products to patients around the world. Our strong track record of execution will be key to our success. Our strategy includes attracting and developing top talent. We do that by cultivating a culture of innovation that delivers a remarkable impact.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
- Support the Global Medical Scientific Information (GSI) function in all aspects related to the Medical Information inquiries.
- Collaborate with the Global Therapeutic Area (TA) Leads to build the CGRD.
- Write, update, and review Medical Information content such as standard response letters (SRLs), frequently asked questions (FAQ) documents, and slide decks (if applicable).
- Attend and contribute to regular GSI team meetings and share any insights and key learnings.
- Train as a member of the Medical Affairs team to gain insight into the various roles within Medical Affairs and other functional groups.
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD from Howard University
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
US Medical- Immunology
Overview:
The US Medical team leads the industry in expertise, innovation and candor by creating and executing on medical strategies that drive measurable health impact, results and value to key decision makers, health care providers and their patients.
Goal:
Provide the fellow with insight into potential career paths in Medical Affairs while providing opportunity to contribute to one or more therapeutic areas within the Immunology team.
Objectives:
- Develop an understanding of how the various functions contribute to the medical affairs team
- Learn how to be effective in a highly matrixed organization, as well as manage vendors
- Become a content expert on the clinical and scientific data around Type 2 inflammation
- Strengthen the collaborative relationships with the Field and Headquarters Medical teams
- Gain experience in field based medical affairs: support coverage and presentations at medical and scientific meetings and engage with KOLs to cultivate an in-depth understanding of cutting-edge information that will help shape the medical strategy
- Lead projects within US Medical, including creation of deliverables and internal resources for teams
Sanofi component:
Understanding medical affairs: As a member of the medical affairs team, the fellow will gain expertise in the development of medical strategy.
Leadership to create impact: Over time, the fellow will have an opportunity to lead initiatives to help build the strategy
of medical affairs for supporting the design of clinical studies, assessment of competitive landscape, and development of educational materials and training.
Develop medical strategy skills: The fellow will get hands on training in medical strategy development, content review, and study design.
Communication and external engagement: The fellow will work on both written and verbal communications through the preparation and presentation of materials. The fellow will represent Sanofi as a support team member for external meetings such as Congresses, Advisory Boards and Investigator Meetings. The fellow interacts with Key Opinion Leaders in the field in order to contribute to the medical strategy.
Ideal candidate:
The ideal candidate for US Medical - Immunology should have:
- PharmD, Biomedical PhD, or relevant Clinical degree
- Effective communication and presentation skills
- Demonstrates scientific expertise - stays abreast of data, treatment trends, and new information in
- the profession and ability to articulate therapeutic knowledge
- Skillfully plans, prioritizes, and executes multiple responsibilities and projects
Location:
Cambridge, MA
Abbvie Pharmaceuticals Medical Affairs Fellowship Program
Program Overview
This 12-month Medical Affairs Fellowship Program is designed to provide recent Pharm.D. or equivalent advanced degree graduates an opportunity to learn the essential skills and experiences required to excel in Medical Affairs organizations across the pharmaceutical industry. The fellow will be an integral part of the U.S. Medical Affairs Facial Aesthetics team and will assist in scientific content development and projects related to the development and execution of the U.S. Facial Aesthetics medical strategy. The overall goal is to provide an opportunity for the fellow to learn the skills necessary for a successful career in the pharmaceutical industry with an emphasis on Medical Affairs. The fellowship is based in Irvine, California.
ABBVIE: Who We Are
We’re focused on sustainable growth and addressing the world’s pressing health challenges. Our mission is to create an innovation-driven, patient-focused specialty biopharmaceutical company capable of achieving sustainable top-tier performance through outstanding execution and a consistent stream of innovative new medicines. Innovative medicines provide compelling patient benefits, differentiated clinical performance, and economic value. Building on our market leadership, we will continue to bring our promoted products to patients around the world. Our strong track record of execution will be key to our success. Our strategy includes attracting and developing top talent. We do that by cultivating a culture of innovation that delivers a remarkable impact.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
- Assist in projects associated with the development and execution of the U.S. Facial Aesthetics medical strategy
- Support scientific content development for products across the Facial Aesthetics portfolio
- Collaborate with the various functions across Medical Affairs, such as Publications, Medical Information, and Medical Science Liaison, and contribute to the successful execution of projects
- Assist in cross-functional projects with R&D, Clinical Development, Health Economics Outcomes Research, and Marketing
- Achieve a high-level knowledge of the therapeutic area
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD from Howard University
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
Amgen: Global Regulatory Affairs
Global Regulatory Affairs (GRA) is responsible for the planning and execution of regulatory strategies for the advancement and approval of our products. GRA colleagues develop strategies that leverage innovative clinical trial designs and expedited approval pathways to efficiently deliver our products to patients. US Regulatory Strategy Fellows are embedded in GRA project teams and directly contribute to the development of our products.
Amgen’s product portfolio spans a broad range of therapeutic areas. We focus on six therapeutic areas:
- Cardiovascular disease
- Oncology, bone health
- Neuroscience
- Nephrolog
- Inflammation
US Regulatory Strategy Fellows participate in a structured development program which is designed to prepare them for a rewarding career in regulatory affairs. Fellows are assigned to project teams and work with a designated preceptor and under the mentorship of experienced regulatory professionals.
During their time in the program, they gain a deeper understanding of the practical considerations of drug development such as navigating a matrix team environment, addressing discordant feedback from multiple regulatory authorities, and negotiating with the FDA.
In addition, Fellows are exposed to European Union, Japan, and China regulatory considerations through regular participation in Global Regulatory Teams.
Astrazeneca Pharmaceuticals Medical Affairs ONCOLOGY PharmD Fellowship Program
Program Overview
This a 2 year Medical Affairs Fellowship Program is designed to provide recent Pharm.D. or equivalent advanced degree graduates an opportunity to learn the essential skills and experiences required to excel in Medical Affairs organizations across the pharmaceutical industry. The fellow will be an integral part of the U.S. Medical Affairs Facial Aesthetics team and will assist in scientific content development and projects related to the development and execution of the U.S. Facial Aesthetics medical strategy. The overall goal is to provide an opportunity for the fellow to learn the skills necessary for a successful career in the pharmaceutical industry with an emphasis on Medical Affairs. The fellowship is based in Irvine, California.
Astrazeneca: Who We Are
We are a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide. Our business is organized to deliver our strategic priorities sustainably, supporting continued scientific innovation and commercial success. We focus on the discovery, development, and commercialization of prescription medicines in Oncology and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. At AstraZeneca, we are driven by our purpose to push the boundaries of science and deliver life-changing medicines. Building high-performing, inclusive and diverse teams that collaborate across the enterprise is part of how live our Value of playing to win.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
- First 6 months: Concentrated clinical oncology experience with Howard University Hospital* plus gradual integration into OBU US Medical Affairs
- Remaining 18 months: Full integration into OBU US Medical Affairs/Medical Strategy (ie, Director Medical Alignment, Medical Director)
- Potential Opportunity for rotation/special projects with other Medical functions
- University Component: Adjunct Faculty appointment at Howard University with teaching requirement
- * Must obtain Washington DC Pharmacy Licensure within 90 days of program start
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD OR PhD from Howard University
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
AstraZeneca Pharmaceuticals Medical Affairs ONCOLOGY PhD Fellowship Program
Program Overview
This 12-month Medical Affairs Fellowship Program is designed to provide recent Pharm.D. or equivalent advanced degree graduates an opportunity to learn the essential skills and experiences required to excel in Medical Affairs organizations across the pharmaceutical industry. The fellow will be an integral part of the U.S. Medical Affairs Facial Aesthetics team and will assist in scientific content development and projects related to the development and execution of the U.S. Facial Aesthetics medical strategy. The overall goal is to provide an opportunity for the fellow to learn the skills necessary for a successful career in the pharmaceutical industry with an emphasis on Medical Affairs. The fellowship is based in Irvine, California.
Astrazeneca: Who We Are
We are a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide. Our business is organized to deliver our strategic priorities sustainably, supporting continued scientific innovation and commercial success. We focus on the discovery, development, and commercialization of prescription medicines in Oncology and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. At AstraZeneca, we are driven by our purpose to push the boundaries of science and deliver life-changing medicines. Building high-performing, inclusive and diverse teams that collaborate across the enterprise is part of how live our Value of playing to win.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
- First 12 months: Full integration into OBU US Medical Affairs/Medical Strategy Team (ie, Director of Medical Alignment, Medical Director)
- Remaining 12 months: OBU US Medical Strategy plus the potential opportunity for rotation/special projects with other Medical Functions
- University Component: Adjunct Faculty appointment at Howard University with teaching requirement
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD OR Ph.D. from Howard University
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
Biomarin Pharmaceuticals Fellowship in Regulatory Affairs and Policy
Program Overview
The Howard University College of Pharmacy, in collaboration with Biomarin Pharmaceuticals and the Food and Drug Administration (FDA), have developed a Fellowship in Regulatory Affairs and Policy. This is a comprehensive program designed to develop highly competent pharmacy professionals in regulatory affairs and policy. This fellowship program seeks to attract qualified candidates with a background in the field of pharmacy, such as PharmD degree holders, who wish to gain extensive training in regulatory affairs and policy. Candidates will have the opportunity to gain hands-on experience in regulatory affairs and policy by working alongside FDA and industry professionals to address real-world challenges.
BioMarin: Who We Are
Established in 1997, BioMarin is a world leader in developing and commercializing first- or best-in-class therapies for rare genetic diseases. We take pride in going where the science leads us, pioneering breakthrough treatments for debilitating and life-threatening conditions where we can significantly improve upon the current standard of care. Our culture revolves around the ethos that no disease should go untreated, and our people are driven to discover, develop, and commercialize medicines that give patients, their families, and their caregivers hope where there was little or none. We fuel our R&D engine by looking for opportunities that align with our strengths and competencies. And we relentlessly pursue exciting, early-stage science that has the potential to change the course of disease.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
- Fellows will spend a predetermined time at Howard University, Biomarin, and the FDA.
- Fellows will matriculate in the Law School for Legislation & Regulation and Administrative Law. They will also advance their knowledge on research and design methods, sit on the Institutional Review Board, complete a teaching certificate, and sit for the Regulatory Affairs Certification examination. In addition, the fellow will gain on-the-job experience and participate in at least three rotational assignments at Biomarin and then close their experience with a six-month rotation at the FDA in either patient labeling or regulatory policy.
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD OR Ph.D.
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
GlaxoSmithKline Pharmaceuticals U.S. Medical Affairs Fellowship Program (Oncology)
Program Overview
GSK is proud to partner with Howard University College of Pharmacy to offer 2-year US Medical Affairs (USMA) Fellowship Programs with a focus in Oncology. Fellows have a unique opportunity to gain practical experience in a clinical setting and apply those learnings in a medical affairs pharmaceutical industry setting. Our goal is to provide the opportunity for fellows to gain the skills, knowledge and experience needed to pursue a career in the pharmaceutical industry. Fellow make impactful contributions to the business as they learn and develop professionally during their fellowship journey.
GSK: Who We Are
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Our values and expectations are at the heart of everything we do and help define our culture - so that together we can deliver extraordinary things for our patients and consumers and make GSK a brilliant place to work. Our values are Patient Focus, Transparency, Respect, Integrity. Our expectations are Courage, Accountability, Development, Teamwork.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
2022-2024 Available Positions – July 1, 2022-June 30, 2024
- 1 US Medical Affairs Oncology Fellow
During the 2-year Fellowship, Fellows will spend approximately 6 months at Howard University Hospital (or partnering clinic) and 18 months at GSK. The Fellowship provides an opportunity to spend 6 of the 18 months in Field Medical (i.e., Medical Science Liaison). In addition, there is an opportunity to gain 1-2 rotational experiences based on the Fellow’s interest and business need such as Global Marketing, Health Outcomes, Medical Information, Global Clinical Safety and Pharmacovigilance.
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD OR Ph.D.
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
GlaxoSmithKline Pharmaceuticals Fellowship in Regulatory Affairs and Policy (FGHRAP)
Program Overview
The Howard University College of Pharmacy, in collaboration with GlaxoSmithKline Pharmaceuticals (GSK) and the Food and Drug Administration (FDA), have developed a Fellowship in Regulatory Affairs and Policy (FGHRAP). This is a comprehensive program designed to develop highly competent pharmacy professionals in regulatory affairs and policy.
The FGHRAP program seeks to attract qualified candidates with a background in the field of pharmacy, such as PharmD degree holders, who wish to gain extensive training in regulatory affairs and policy. Candidates will have the opportunity to gain hands-on experience in regulatory affairs and policy by working alongside FDA and industry professionals to address real-world challenges.
GSK: Who We Are
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines, and consumer healthcare products. Our goal is to be one of the world’s most innovative, best performing, and trusted healthcare companies. Our values and expectations are at the heart of everything we do and help define our culture - so that together we can deliver extraordinary things for our patients and consumers and make GSK a brilliant place to work. Our values are Patient Focus, Transparency, Respect, Integrity. Our expectations are Courage, Accountability, Development, Teamwork.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
«Fellows will spend a predetermined time at Howard University, GSK and the FDA.
«Fellows will matriculate in the Law School for Legislation & Regulation and Administrative Law. They will also advance their knowledge on research and design methods, sit on the Institutional Review Board, complete a teaching certificate, and sit for the Regulatory Affairs Certification examination. In addition, the fellow will gain on-the-job experience and participate in at least three rotational assignments at GSK and then close their experience with a six-month rotation at the FDA in either patient labeling or regulatory policy.
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD OR Ph.D. from Howard University
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
GlaxoSmithKline Pharmaceuticals U.S. Medical Affairs Fellowship Program (Primary Care/Respiratory)
Program Overview
GSK is proud to partner with Howard University College of Pharmacy to offer 2-year US Medical Affairs (USMA) Fellowship Programs with a focus in Primary Care/Respiratory. Fellows have a unique opportunity to gain practical experience in a clinical setting and apply those learnings in a medical affairs pharmaceutical industry setting. Our goal is to provide the opportunity for fellows to gain the skills, knowledge and experience needed to pursue a career in the pharmaceutical industry. Fellow make impactful contributions to the business as they learn and develop professionally during their fellowship journey.
GSK: Who We Are
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Our values and expectations are at the heart of everything we do and help define our culture - so that together we can deliver extraordinary things for our patients and consumers and make GSK a brilliant place to work. Our values are Patient Focus, Transparency, Respect, Integrity. Our expectations are Courage, Accountability, Development, Teamwork.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
2022-2024 Available Positions – July 1, 2022-June 30, 2024
- 1 US Medical Affairs Primary Care/Respiratory Fellow
During the 2-year Fellowship, Fellows will spend approximately 6 months at Howard University Hospital (or partnering clinic) and 18 months at GSK. The Primary Care/Respiratory Fellowship provides an opportunity to spend 6 of the 18 months in Field Medical (i.e., Medical Science Liaison). In addition, there is an opportunity to gain 1-2 rotational experiences based on the Fellow’s interest and business need such as Global Marketing, Health Outcomes, Medical Information, Global Clinical Safety and Pharmacovigilance.
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD OR Ph.D.
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
GlaxoSmithKline Pharmaceuticals U.S. Medical Affairs Fellowship Program (Vaccines)
Program Overview
GSK is proud to partner with Howard University College of Pharmacy to offer 2-year US Medical Affairs (USMA) Fellowship Programs with a focus in Vaccines. Fellows have a unique opportunity to gain practical experience in a clinical setting and apply those learnings in a medical affairs pharmaceutical industry setting. Our goal is to provide the opportunity for fellows to gain the skills, knowledge, and experience needed to pursue a career in the pharmaceutical industry. Fellow makes impactful contributions to the business as they learn and develop professionally during their fellowship journey.
GSK: Who We Are
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Our values and expectations are at the heart of everything we do and help define our culture - so that together we can deliver extraordinary things for our patients and consumers and make GSK a brilliant place to work. Our values are Patient Focus, Transparency, Respect, Integrity. Our expectations are Courage, Accountability, Development, Teamwork.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
2022-2024 Available Positions – July 1, 2022-June 30, 2024
- 1 US Medical Affairs Vaccines Fellow
During the 2-year Fellowship, Fellows will spend approximately 6 months at Howard University Hospital (or partnering clinic) and 18 months at GSK. This fellowship is geared towards people who are interested in pursuing a career in ID or vaccinology/vaccines.
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
PharmD with clinical experience (1-2 years of residency, or equivalent clinical experience) Preferred
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
Janssen Pharmaceuticals Medical Information | Medical Affairs | Value and Evidence Scientific Engagement Fellowship Program
Program Overview
Medical Information: Hone skills in critiquing and communicating complex scientific information to a variety of audiences, including consumers, health-care professionals, and health-care policy decision makers.
Payer & Health-Systems: Provide advanced skill training in an emerging area focused on meeting the needs of payers, health systems, and clinical decision resource organizations (CDROs) such as compendia, value framework organizations, etc.
Medical Affairs: Provide the opportunity to enhance interpersonal communications through cross-functional team collaboration and engage and collaborate with subject matter experts across medical affairs.
Value and Evidence Scientific Engagement: Work with cross-functional teams to support the generation of scientific evidence intended to inform health care decision-makers.
Janssen: Who We Are
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
Year 1:
- Janssen Medical Information and Knowledge Integration and Payer and Health Systems (12 months)
Year 2:
- Janssen Medical Affairs (6 months)
- Janssen Value and Evidence Scientific Engagement (6 months)
- Location: Horsham, PA & other travel possible
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD or will have a PharmD at the commencement of program
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
Pfizer Pharmaceuticals Global Labeling Management (GLM)/ Global Medical (GMI) Information Fellowship
Program Overview
The GLM/GMI Fellowship is a unique program that is designed to provide customized and practical learning opportunities that will provide the Fellow with valuable experience in both GLM and GMI which will enable the Fellow to prepare for a strong career in the pharmaceutical industry.
GMI: Who We Are
The mission of GMI is to empower our customers to make informed decisions through quality interactions that benefit patients. Global Medical Information aims to strengthen Pfizer’s mission and purpose by ensuring access to information and knowledge that significantly impacts patient care. Our product expertise and customer interactions enable us to share valuable insights with our internal partners and to develop innovative solutions that support the Medical Information needs of our customers.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
Year 1 of Fellowship Program
GLM will be able to provide Fellow candidates extensive exposure and hands-on experience in:
«Developing comprehensive knowledge of labeling regulations and real-world applications of development of product labels.
«Creation, revision and maintenance of our Core Data Sheets, USPIs and SmPCs.
«Working closely with matrix teams and interacting with the Subject Matter Experts (SMEs) from many areas of the company such as Regulatory Strategists, Safety, Clinical, Medical and many other colleagues.
Year 2 of Fellowship Program
The GMI fellow will expand on the development of their foundational skills. The responsibilities will include:
- Developing strong skills: written and verbal communication, literature searching and the ability to critically evaluate the scientific literature, data and evidence
- Creating, maintaining and optimizing local, regional and global MI document collections by ensuring that responses are medically and scientifically accurate, timely, fair balanced, and meet customers’ needs
- Developing strong knowledge of industry standards and guidance documents
- Synthesizing clinical data regarding marketed and investigational products and/or therapeutic areas of interest
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD or will have a PharmD at the commencement of program
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
Genentech Pharmaceuticals Product Development Operations (PDG) Focused Fellowship
Program Overview
We would welcome a Howard Fellow to join PDG and contribute to our purpose through becoming a study manager on a team that is operationalizing a trial and/or get involved in some of the enabling work that we do to innovate our clinical trial work. Work as a study manager could include working with vendors, executional planning (ie demand, budget), partnering with stakeholders in Roche that sit in other functions, working with the people in the countries where the trials are being run, managing risk and compliance, interacting with sites, making operational decisions that lead to the best decisions for patients are a few examples. Work in the enabling space would be focused on innovations that allow us to do what we do better.
Genentech: Who We Are
Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. PDG Clinical Operations is a group of people that operationalize phase 1b to phase 4 clinical trials globally. Essentially we take the great science that Roche / Genentech discovers and try to move it to an approved medication by partnering cross-functionally to develop and operationalize clinical trials in partnership with physicians who enroll patients at their clinic. We work in over 40 disease areas in the therapeutic areas of oncology, neuroscience, infectious diseases, ophthalmology, inflammation and run over 400 trials that we hope will bring benefit to all patients and their loved ones.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
- 6 months @ Howard University: Fellows will learn the foundations of legislation and regulation and administrative law from the Law School; complete a teaching certificate with the College of Pharmacy; sit on the Institutional Review Board, and prepare for RAC Certification.
- 12 months @ Genentech Washington DC Offices: The Fellow will complete at least 3 rotations while working with the Regulatory Intelligence and other cross-functional teams to gather information on the latest industry trends and health authority policies. Fellows will be exposed to policymakers both internal and external to Genentech and externally on Capitol Hill.
- 6 months @ FDA: The Fellow will operate as a contractor for either the Division of Medical Policy Program or the Division of Medical Policy Development working on innovative projects within the division.
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD OR Ph.D.
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
Genentech Pharmaceuticals Personalized Healthcare (Phc) Focused Fellowship
Program Overview
Today only a fraction of humanity receives the best healthcare. The focus needs to broaden—from treating disease…to delivering patient-centered healthcare. At Roche, personalized healthcare means better health, at a lower cost, for people and society. It means shifting from a one-size-fits-all approach to the best care for each person.
We would welcome a Howard Fellow to join our PHC team and engage in the following activities:
- Innovation lifecycle and portfolio management strategies
- Development of business models and go to market strategy development
- Idea/concept refinement for integrated solution(s)
- Ecosystem/landscape research and insights (digital health, integrated solutions, etc.)
Genentech: Who We Are
Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. We endeavor to be a connector, catalyst and contributor in this effort - and our PHC team is responsible for driving this progress across our product development organization and beyond. We are partnering across society to create new approaches and solutions, mindful of the urgency of this moment. To us, personalized healthcare means far more than improving treatment—it’s about improving life for every person.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
- 6 months @ Howard University: Fellows will learn the foundations of legislation and regulation and administrative law from the Law School; complete a teaching certificate with the College of Pharmacy; sit on the Institutional Review Board, and prepare for RAC Certification.
- 12 months @ Genentech Washington DC Offices: The Fellow will complete at least 3 rotations while working with the Regulatory Intelligence and other cross-functional teams to gather information on the latest industry trends and health authority policies. Fellows will be exposed to policymakers both internal and external to Genentech and externally on Capitol Hill.
- 6 months @ FDA: The Fellow will operate as a contractor for either the Division of Medical Policy Program or the Division of Medical Policy Development working on innovative projects within the division.
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD OR Ph.D.
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
Genentech Pharmaceuticals Regulatory Policy Fellowship
Program Overview
Regulatory Policy Fellows are assigned their responsibilities as business needs dictate, and often perform work that transcends multiple or all therapeutic areas. Regulatory Policy Program Fellows work in close coordination with other members of the policy team and under the supervision of their manager. They project manage the implementation of regulatory policy strategies based on regulatory and legislative trends important to Roche’s product portfolio. Regulatory Policy Fellows work to support planning regulatory and advocacy positions and facilitate engagement with regulators and Key Opinion Leaders on key topics of interest. Regulatory Policy Fellows support and participate in activities with trade associations, think tanks, advocacy organizations, and regulatory authorities. They are also responsible for identifying, documenting, coordinating, and communicating regulatory policy activities and information.
Genentech: Who We Are
Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Regulatory Policy is part of the broader Product Development Regulatory (PDR) organization that interprets the needs of worldwide health authorities and provides strategic information necessary to advance the development and business priorities of, the Roche Group (“Roche”). PDR policy is committed to developing regulatory frameworks that are evidence-based, innovative, ethical, and influential in the industry.
HOWARD: WHO WE ARE
Howard University is a comprehensive, research-oriented, historically Black private university providing an educational experience of exceptional quality to students of high academic potential with particular emphasis upon the provision of educational opportunities to promising Black students. Further, the University is dedicated to attracting and sustaining a cadre of faculty who are, through their teaching and research, committed to the development of distinguished and compassionate graduates and to the quest for solutions to human and social problems in the United States and throughout the world.
JOB Summary
«The fellow will function as a Regulatory Policy Analyst and will support the Regulatory Policy team on the following activities at Genentech:
«Continues to expand his/her knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics
«Obtains and applies in-depth knowledge of regulatory guidelines, procedures and best practices
«Writes, coordinates analyzes, and/or reviews comments on regulatory or legislative initiatives and guidance
«Supports interactions on policy and advocacy issues, including building relationships with key regulatory decision-makers
Application Requirements
Curriculum Vitae, Letter of Intent, Official Transcript, and 3 Letters of Recommendation
ELIGIBILITY CRITERIA
Graduated with PharmD OR Ph.D.
How to Apply:
Submit application via email Earl.Ettienne@Howard.edu upon completion
Genentech: Regulatory Program Management
The successful candidate will participate directly with one or more of our current molecule teams, develop and implement innovative regulatory strategies from pre-clinical through to Phase 4 molecules, including direct interactions with the FDA. This is an opportunity to explore applying a science background in a business environment for the development of new medicines.
The successful candidate will be working towards or have recently (within the last two years) completed an undergraduate degree, preferably in the biological sciences. Candidates may have recently completed a graduate degree (within 2 years of graduation) or be currently enrolled in a graduate program. Candidates may be PharmD or PhD graduates, but those degrees are not required.
- Understand the needs of the project and proactively drive them
- Adapt and respond to changes in a positive and thoughtful manner
- Be comfortable with uncertainty and support a team through challenges
- Able to balance multiple priorities and organize their time effectively
- Identify and solve problems and, if needed, escalate issues appropriately
- Use of interpersonal skills and influence to accomplish work without formal authority
Genentech: US Regulatory Policy
Regulatory Policy interprets the needs of worldwide health authorities and provides strategic information necessary to advance Genentech/ Roche’s development and business priorities. The regulatory policy group is committed to developing frameworks that are evidence-based, innovative, ethical, and influential in the industry.
- Knowledge: Understanding/ familiarity with US regulations pertaining to drugs, biologics, and devices; understanding of processes, procedures, and issues in drug/biologics/device development. Includes knowledge of ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, and other relevant guidelines.Understanding/familiarity with the US system of government.
- Understanding of processes in the US Congress, the relationship between the three branches of government, and basic understanding of the legal processes underpinning regulations and regulatory frameworks as relates to the Food, Drug and Cosmetics Act. Understanding and familiarity with the Prescription Drug User Fee Act Reauthorization process and contents. Familiarity with competitive activity in the field
- Communication: Strong written and verbal communications skills, as well as the ability to draw on various techniques to connect and engage a range of internal and external individuals, groups, and cultures, is critical.
- Project Management Skills: The capability to both gain and apply knowledge of fundamental project management processes.
- Planning Skills: The capability to create and deliver creative and efficient plans, strategies, programs, and tactics against advocacy engagement is critical.
- Strategic Business Acumen: The capability to both gain and employ knowledge of Genentech and its business, strategy, priorities, and activities -- as well as the ability to understand a cohesive strategy and align tactical work to that vision.
- Time Management: The capability to manage both one’s own time and that of an initiative/project to a very high standard.
- Team-Building Skills: The capability to encourage and enable people to work together as a team to accomplish the project, including nurturing relationships with agency and external consultant resources.
Genentech: Product Development Medical Affairs, Patient Partnerships
The Global Patient Partnership team leads patient community engagement for specific disease areas (DAs) and/or above-DA topic(s) with the goal of driving the inclusion of the patient perspective into all aspects of the company’s plans. Facilitates, initiates, streamlines, and manages collaborations between Roche and the patient community that follow key principles of mutual value, Integrity and equity, independence and mutual respect, and transparency.
- Ability to build deep and meaningful relationships with patient stakeholders
- Emotional intelligence and ability to see issues from both, a patient/patient community and Roche perspective to drive mutually valuable solutions forward
- Adaptability and open-mindedness to collaboratively learn, address and solve new topics and situations
- Ability to learn and work across multiple cultures and countries
- High ethical standards and the ability to view the world from the patient’s perspective
Genentech: US Patient Advocacy Relations
Genentech's External Affairs department is seeking a fellow to help Genentech prioritize and evaluate policies and partnerships with a health equity lens. Possible projects could be:
- Craft a Health Equity set of guidelines or practices for the internal application of a health equity lens in policy and or partnership development. Such guidelines should explicitly acknowledge the existence of structural racism as well as other structural barriers to health.
- Identification of key data elements that are necessary to evaluate policy impacts on equitable access and inform creation of policy.
- Explore partnerships and policy avenues for assisting underserved and marginalized patients with Alzheimer's Disease
Qualified candidates would have a background in external affairs, policy development, and/or health equity work.
Genentech: Chief Diversity Office
Genentech embraces the increasingly diverse world around us. Our mission is to be the industry leader to deliver scientific innovations that drive better outcomes for our people, patients, business, and communities by advancing and boldly championing diversity, equity, and inclusion. We have three pillars to anchor our D&I work, to Foster Belonging, Advance Inclusive Research (AIR) & Health Equity (HE) and Transform Society. (See our annual report https://www.gene.com/stories/our-commitment-to-diversity-inclusionengage)
The Fellow has an opportunity to contribute to our 2025 Diversity & Inclusion commitments in Health Equity to establish Genentech as a leader and partner of choice. The Fellow will have exposure to a variety of CDO AIR/HE partnerships including Regional HE Symposia, External Council of diverse advisors in Medicine, Site Alliance, and external communication and publication strategy. The individual will be exposed to the business enterprise as part of our overall health equity engagement strategy.
Skillsets that the candidate can lean into:
- Diverse Leadership, Enterprise mindset
- Scientific development process
- Health Equity integrated into medicine and business
- Presentation/Communications skills, Scientific writing
- Interview skills, Networking
Genentech: US Medical Affairs SciOps/EG, MedInfo or US Patient Safety
For USMA Scientific Operations, we propose that the Fellow would do two 6 month rotations of the Fellow's choosing. Our preference is for a PharmD graduate only as this qualification would enable the Fellow to do any of the rotations. The Fellow can choose 2 rotations from the below 5 options.
- Sr. Clinical Trial Leader, Evidence Generation (EG)
- Works within a cross-functional EG cluster to develop the USMA data and insights generation strategy as part of the USMA Strategic Medical Plan, and to execute clinical trials, studies, and projects, and/or manage systems, vendors, and data.
- Pharmacovigilance Operations Associate, US Patient Safety (US PS)
- Provides operational support to the US Patient Safety Clinical and Vendor Oversight teams to ensure proper performance of baseline PV compliance-based responsibilities. This is done through implementation and regulation of global processes, local legislation, case investigation, and study management. Responsibilities are performed under the direction of the PV Operations Manager.
- Product Lead, Medical Information (MI)
- Focused on developing the implementation plan as well as executing on content creation for multiple channels in a specific therapeutic area to assure scientifically accurate, impactful communications to patients, healthcare professionals, and/or access stakeholders. Key responsibilities include planning, execution, creation, and review of scientific content for customer engagement, responding to medical and/or access inquiries, and strategic application of customer insights.
- Compliance Manager, Medical Compliance (gMAC)
- Provides trusted compliance guidance for Healthcare, Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) activities that impact U.S. Medical Affairs. This position works closely with other members of gMAC, U.S. Medical Affairs functions, and other compliance teams to advance innovative, patient-focused solutions.
- Business Strategy and Operations Manager, Business Strategy and Operations (BSO)
- Provides strategic thought partnership to USMA stakeholders, manages functional and network activities and facilitates multiple business processes required to ensure the function or network is able to successfully and compliantly execute on its strategic plans.
Genentech: US Medical Affairs (USMA) /Customer Engagement
The USMA, Customer Engagement - Field Medical Fellowship is a one-year program designed to expose and immerse the Fellow into a range of corporate and field-based initiatives that influence and enable patient care across the healthcare landscape. The focus will be on gaining exposure and understanding of how patient care delivery decisions are made across the broad customer landscape from providers, payers, health system administrators, and others instrumental to the patient journey.
Key Competencies and Requirements for Field Medical Fellow
Seeking candidates who are passionate about enhancing patients’ lives and contributing to innovation in our healthcare system, with a curiosity and drive to learn about the pharmaceutical industry through the lens of Medical Affairs as a Field Medical Fellow. Experience in leadership roles and as a team player is highly preferred. Additional attributes include openness to other viewpoints, willingness to try different approaches, and exceptional communication and interpersonal skills.
- Demonstrates understanding of pharmacist roles within the industry as well as across the healthcare landscape (payer, PBMs, health systems, clinical, etc)
- Prior experience (internship, rotation, etc) preferred but not required
- Demonstrates knowledge of Medical Affairs/Field Medical function
- Prior experience (internship, rotation, etc) preferred but not required
- Demonstrates understanding that the U.S. healthcare system provides disparate access to care and is passionate about improving care holistically
- Must be able to prioritize customer engagements locally and regionally on a regular basis with field medical colleagues. Strong desire to understand who, what, and how customers make decisions on behalf of patients.
- Displays professional maturity during the interview process and any additional engagements
- History of past projects that display leadership, taking initiative, and the ability to work independently to achieve an outcome
- Past or current experience as a leader
- Formal (Student societies, professional groups, etc.) or informal (project-based)
- Determine actual contribution to team and leadership presence regardless of title
- Should be a “self-starter” with the ability to make an immediate impact
- The candidate should be adaptable and able to work independently, with little direct guidance/supervision
- Exhibits excellent communication skills - verbal, written, and interpersonal
- Demonstrates ability to communicate across various platforms (presentations, WebEx/telecons, etc.)
- Ability to leverage baseline therapeutic knowledge achieved through Pharm. D. training to shift quickly across opportunities that may require deeper therapeutic area knowledge or broader application. Demonstrated clinical acumen with the ability to learn quickly.
- Ability to develop relationships quickly and work across multiple stakeholders. Contributes to overall success of a team or cross-functional group.
- Demonstrates a “patients first” mindset and recognizes that to continually help patients, one must embrace a life of continuous learning
- Mindset – how does the candidate approach:
- Navigating ambiguity and change
- Collaboration across teams
- Handling challenging situations
- Customer focus and impact
- Enterprise mindset and portfolio impact
Genentech/Howard Fellowship in Clinical Pharmacology
General Program Mission
A world leader in clinical research, Genentech has generated large clinical databases from multiple randomized clinical trials and registries. Genentech believes in the importance of building on this data. Genentech has established the Fellowship to rely on the synergy between Genentech’s focus on continued innovation and clinically relevant research and the Fellow’s clinical expertise and passion for clinical research.
Scope of Work
The Fellow will function as a clinical pharmacologist and will support research and development projects, which may include the following activities:
· With guidance from the Genentech and Institution mentors, design and implement a clinical pharmacology and/or modeling and simulation research project(s);
· Present the results of the research project(s) at Genentech, Institution, a local and/or national scientific meeting and/or publish them in a peer-reviewed journal;
· Serve as a Clinical Pharmacology lead for a healthy volunteer study for a small and/or large molecule project (e.g., food effect, drug-drug interaction, comparability);
· Serve as a Clinical Pharmacology lead on cross-functional project sub-teams (i.e. clinical, pharmacology, biomarkers), facilitating discussions of clinical pharmacology-related issues;
· Develop clinical pharmacology plans for small and/or large molecule projects and obtain buy-in from the project team with support from their mentor;
· Author clinical pharmacology sections of clinical documents (e.g., clinical trial protocols, investigator brochures, clinical study reports);
· Develop modeling and simulation skills (e.g., non-compartmental, compartmental, pharmacokinetic/pharmacodynamics (“PK/PD”), and population PK modeling);
· Develop an understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”), Food and Drug Administration (“FDA”), European Medicines Agency (“EMA”), and other relevant Clinical Pharmacology guidances and apply relevant guidance in their work.
Program Description
· The Fellowship builds on the synergy between the Fellow’s broad Doctor of Pharmacy training and Genentech’s innovation in drug development to prepare the individual for a career in the biotechnology/pharmaceutical industry. The Fellow will be part of the Genentech Research and Early Development (“gRED”) Clinical Pharmacology Department, which is responsible for applying the principles of quantitative pharmacology to enable the selection of a safe and effective dose, route, and regimen for small molecules and biologics. The Fellow will gain drug development experience at Genentech by completing research projects in clinical pharmacology and/or modeling and simulation and collaborating with scientists across disciplines. These experiences will potentially lead to publications and presentations at scientific conferences and give the Fellow exposure to career opportunities in the biotechnology/pharmaceutical industry.
Sanofi: US Medical-Immunology
The US Medical team leads the industry in expertise, innovation, and candor by creating and executing medical strategies that drive measurable health impact, results, and value to key decision-makers, health care providers, and their patients.
Program Goal:
Provide the fellow with insight into potential career paths in Medical Affairs while providing an opportunity to contribute to one or more therapeutic areas within Immunology team.
Primary Objectives:
- Develop an understanding of how the various functions contribute to the medical affairs team
- Learn how to be effective in a highly matrixed organization, as well as manage vendors
- Become a content expert on the clinical and scientific data around Type 2 inflammation
- Strengthen the collaborative relationships with the Field and Headquarters Medical teams
- Gain experience in field based medical affairs: support coverage and presentations at medical and scientific meetings and engage with KOLs to cultivate an in-depth understanding of cutting-edge information that will help shape the medical strategy
- Lead projects within US Medical, including the creation of deliverables and internal resources for teams
Understanding medical affairs: As a member of the medical affairs team, the fellow will gain expertise in the development of medical strategy.
Leadership to create impact: Over time, the fellow will have an opportunity to lead initiatives to help build the strategy of medical affairs for e.g. supporting the design of clinical studies, assessment of competitive landscape, and development of educational materials and training.
Develop medical strategy skills: The fellow will get hands-on training in medical strategy development, content review, and study design.
Communication and external engagement: The fellow will work on both written and verbal communications through the preparation and presentation of materials. The fellow will represent Sanofi as a support team member for external meetings such as Congresses, Advisory Boards, and Investigator Meetings. The fellow interacts with Key Opinion Leaders in the field in order to contribute to the medical strategy
The ideal candidate for US Medical-Immunology should have:
- PharmD, Biomedical PhD, or relevant Clinical degree
- Effective communication and presentation skills
- Demonstrates scientific expertise - stays abreast of data, treatment trends, and new information in the profession and ability to articulate therapeutic knowledge
- Skillfully plans, prioritizes, and executes multiple responsibilities and projects
Sanofi: Translational Medicine and Early Development (TMED)
Program Goals: To provide the fellow with exposure to multiple fields, which comprise Translational Medicine and Early Development during the initial months. Subsequently, to provide intensive hands-on training in one of the disciplines for the majority of the fellowship, based on the fellow’s preference. Upon successful completion of the program, the fellow will have gained considerable expertise in the chosen field of interest in the setting of an innovative R&D organization in a large biopharmaceutical company.
Objectives:
- In the initial months, the fellow will be introduced to three fields within Translational Medicine and Early Development. These are PKDM (Pharmacokinetics, Pharmacodynamics and Metabolism), TMCP (Translational Medicine and Clinical Pharmacology, and EDO (Early Development Clinical Operations).
- PKDM is likely to be of particular interest to the fellow with extensive quantitative skills. TMCP may be especially appealing to the fellow interested in the bridge between Research and Development, biomarkers, and Phase 1 study design. EDO is likely to be attractive to the fellow who wants to be closest to the nuts and bolts of study execution and the patient-centric perspective.
- In the selected field of focus, the fellow will be closely mentored by a staff member and will gain hands-on experience in actual clinical trials
The fellow will also attend seminars and other group meetings to ensure a deep and broad learning experience
Sanofi: Clinical Science & Operations
Program Goals: Provide the fellow with insight into potential career paths in clinical development while providing the opportunity to contribute to one or more clinical study teams.
Objectives:
- Develop an understanding of how the various functions contribute to a clinical study team
- Learn how to be effective in a highly matrixed organization, as well as manage vendors
- Become familiar with clinical study documentation (e.g. protocols, investigator brochure, informed consent form); how they are designed, written, and distributed during the course of a study
- Contribute to a study feasibility assessment, taking into account the site, and patient perspective
- Use multiple sources of data to build and/or manage a study budget
- Contribute to the construction of an operational plan including supply chain management strategy
- Become familiar with the quality and regulatory standards expected of our study teams
- Partner with CSO to implement clinical trial diversity strategy
Sanofi: Global Regulatory Affairs – Specialty Care
Program Goals: Gain hands-on experience across a variety of specialties within the Global Regulatory Affairs department. Develop a well-rounded understanding of the regulatory functions and drug development process from early stage to postmarketing. Lead team meetings, develop regulatory strategy, and contribute to and lead Health Authority submissions with increasing responsibility throughout the Fellowship program.
Objectives:
- Develop regulatory strategic skills while contributing to global pre- and post-approval planning and submissions.
- Partner with Medical, Legal, Marketing, and Safety in delivering products for diseases globally.
- Gain experience in the review and approval of promotional materials, including effective feedback skills.
- Opportunity to engage with global colleagues and learn country/region-specific regulatory processes.
Develop strong communication and project management skills.
Sanofi: R&D North America Operations
Program Goals: The Global Operations team provides and leads a supportive environment for our people to maximize the value of our pipeline and bring transformative drugs to patients. R&D North America Operations supports R&D teams with processes and tools, knowledge, and collaborative networks to ensure best-in-class implementation of our project strategies and maximize engagement of people across all sites. The program goal is to provide the Fellow with the experience and opportunities to interact with multi-disciplinary teams in driving projects that enable R&D Operations across North America.
Objectives:
- Develop R&D operations project and data management skills
- Obtain experience in relevant data processing and presentation/visualization
- Obtain insight on how to connect different sources of data and gain insight across multiple R&D groups/ functions
- Develop proficient communication skills when interacting with internal and external stakeholders
Become knowledgeable of current Biopharma and scientific trends
Sanofi: Government Relations and Patient Advocacy Fellow
Program Goals: Provide the Fellow with the necessary hands-on experiences, knowledge, and skills to make a positive impact for patient health outcomes. The Fellow will enhance their understanding of the US healthcare system through leadership on cross-functional projects that aim to develop timely, evidence-based, and patient-centric solutions. Projects will be within US and Global Public Affairs & Patient Advocacy, US Government Relations, and US Public Policy, all under the Corporate Affairs umbrella.
Objectives:
- Build and maintain external advocacy relationships by liaising with patient groups, medical and professional societies, health foundations, and other stakeholders in the advocacy community, to inform internal decision-making and patient-centric initiatives.
- Analyze the impacts of US legislative and reimbursement developments for patient access to Sanofi medicines and vaccines.
- Work with the team on the Hill that enables policy makers to make informed decisions, incorporating the patient perspective.
- Gain exposure within different treatment areas such as oncology, rare diseases, rare blood disorders, immunology, general medicines, and vaccines.
Opportunity to work with global colleagues and gain perspectives beyond the US healthcare ecosystem.