Clinical Lead Early Clinical and Experimental Therapeutics

About the Job

Join the Early Clinical and Experimental Therapeutics (ECET) department as a Clinical Lead, driving translation between preclinical development through early clinical development and beyond. This position within the Translational Medicine Unit (TMU)/Clinical and Patient Sciences (CPS)/ECET is responsible for ECET contributions across all therapeutic areas at Sanofi, including small molecule, monoclonal antibody, peptide, and gene therapy modalities.

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.
• 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 and Proof-of-Concept studies.
• Supervise the execution and ensure close medical monitoring.
• Review, interpret results, and author ECET-related clinical documentation, including informed consent forms, clinical protocols, study reports, abstracts and/or manuscripts, and regulatory documents.
• Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaise with partners on projects.
• Participate in dose selection for First-In-Human studies and drive Go/No Go decisions.
• Ensure adequate follow-up of studies and project timelines.
• Present data at appropriate meetings inside or outside Sanofi.

Study Medical Manager Responsibilities

• Design and conduct early clinical development studies including phase 2a within planned timelines.
• Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents).
• Coordinate clinical team to set-up and follow the study.
• Ensure proper documentation is provided to Ethics Committees and Health Authorities.
• Ensure that the study is scientifically sound and correctly conducted.
• Prepare and review interim investigator reports.
• Lead the Dose Escalation Meeting and document decision making for First-in-Human studies.
• Review Adverse Event reports.
• Participate in data review and validation meetings before database lock.
• Prepare and distribute the Key Results Memo and prepare/review the Clinical Study Report.

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

Soft and Technical Skills

• Excellent communication skills (verbal and written) for interactions across functional areas and with key regulatory agencies
• Demonstrated capability to challenge decisions and status quo with a risk-management approach
• Ability to work within a matrix organization
• International/intercultural working skills
• Open-minded to apply new digital and/or AI-driven solutions
• Fluent in English