Clinical Science and Operations
OVERVIEW:
The Clinical Sciences and Operations (CSO) platform is responsible for the planning, execution, and reporting and clinical trials at Sanofi. Running trials to specific timelines, within budget, and to rigorous quality standards requires teams of dedicated associates playing a plethora and 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 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: Clinica 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 pharmaceutical industry.
- Eligible to work in the United States
- 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 in upholding ethics and transparency addressing environmental challenges.