Sanofi: 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 multidisciplinary 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.
GOALS:
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 and disease area, other compounds in development, new insights on pathogenesis.
- Prepares and publish data and 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 fellows interact with Key Opinion Leaders in the field in order to the develop protocol, choose investigators, etc.
IDEAL CANDIDATE:
- PharmD or Ph.D.
- 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
- Agility in the application of new digital solutions
PRECEPTOR:
Annie Kruger