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 non-clinical and clinical development. BCB functions as 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 biding 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 non-clinical or clinical development.
- The fellow will lead a non-clinical or clinical program while being closely mentored by staff member and gain hands-on experience in non-clinical 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 are 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 communications skills.
- Networking: The fellow will have extensive opportunities 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.