Clinical Lead Early Clinical and Experimental Therapeutics
About The Job
Your skills could be critical in helping our teams accelerate progress. Join our state-of-the-art ECET department as a Clinical Lead, ECET and you'll drive the translation between preclinical development through early clinical development and beyond, while enjoying lots of opportunities to broaden your experience and hone your skills. This position located within the Translational Medicine Unit (TMU)/Clinical and Patient Sciences (CPS)/Early Clinical and Experimental Therapeutics (ECET) is responsible for ECET contributions across all therapeutic areas at Sanofi and with a scope that includes small molecule, monoclonal antibody, peptide, gene therapy including nucleic acid modalities. The individual in this position is an integral part of the therapeutic area project teams and cross-functional Translational Medicine Subteam from preclinical development through post-marketing.
Main Responsibilities
- Participate in designing the early development plan and overall ECET plan for the different steps of clinical development, integrating it into the overall development strategy in collaboration with the responsible Therapeutic Area in research and development.
- Design safe, rapid and informative First-In-Human studies including First In Patients, natural history, experimental model validation, mechanistic and signal seeking, streamlined Proof-of-Mechanism as well as Proof-of-Concept studies providing robust data for early Go/No Go decisions, and other pharmacokinetic studies.
- Serve as the Study Medical Manager (SMM) for selected clinical studies, serving as the primary point of contact for the study team.
- Ensure an adequate follow-up of studies and project timelines.
- Present data at appropriate meetings (inside or outside Sanofi).
Major Challenges And Opportunities
- Spokesperson of TMU and Clinical Patient Sciences; requires a committed and enthusiastic person to emphasize the strengths of the position and a positive, collaborative mindset.
- Take an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic and proactive person.
- Ensure Clinical Trial standards are maintained at the site and in cooperation with the other clinical functions.
- Manage aggressive timelines effectively through cross-functional planning.
- Decision Making Authority: Make front-line decisions on protocol design, execution, dose escalation and safety.
- Provide information for Regulatory authorities.
Qualifications
- M.D. or equivalent
- At least 1 year experience in the design and execution of early development clinical trials (phase 1a/b and 2a) OR at least one year experience in exploratory studies within a pharmaceutical, academia, hospital or CRO setting.
- Postgraduate residency training
Preferred Qualifications
- M.D./Ph.D
- Laboratory research experience in industry or academia
- Knowledge and mindset in translational research
- Broad biomedical knowledge base
- Able to acquire and apply new technical skills
- Experience in the conduct of late phase clinical trials
Soft And Technical Skills
- Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
- Demonstrated capability to challenge decisions and status quo with a risk-management approach
- Ability to work within a matrix organization, within CPS, TMU, R&D and beyond e.g. Medical
- International/ intercultural working skills
- Open-minded to apply new digital and/or AI-driven solutions
Languages
Fluent in English.
About You
Minimum Required Qualifications
- M.D. or equivalent
- At least 1 year experience in the design and execution of early development clinical trials (phase 1a/b and 2a) OR at least one year experience in exploratory studies within a pharmaceutical, academia, hospital or CRO setting.
- Postgraduate residency training
Preferred Qualifications
- M.D./Ph.D
- Laboratory research experience in industry or academia
- Knowledge and mindset in translational research
- Broad biomedical knowledge base
- Able to acquire and apply new technical skills
- Experience in the conduct of late phase clinical trials