Clinical Lead, Early Clinical and Experimental Therapeutics

Role Summary

Clinical Lead, Early Clinical and Experimental Therapeutics (ECET) drives translation between preclinical development and early clinical development across therapeutic areas, including small molecules, monoclonal antibodies, peptides, and gene therapies. The role focuses on rapid proof-of-mechanism/concept, natural history studies, and human target validation, collaborating with multidisciplinary teams to assess pharmacology, efficacy signals, and safety to inform early Go/No Go decisions.

Responsibilities

• Participate in designing the early development plan and overall ECET plan for the different steps of clinical development, integrating 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.
• 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; some abstracts and/or manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents.
• Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaises with partners on projects.
• Participate in the dose selection for First-In-Human studies, drive Go/No Go decisions when needed.
• Ensure an adequate follow-up of studies and project timelines.
• Present data at appropriate meetings (inside or outside Sanofi).
• Present data at appropriate meetings (inside or outside Sanofi).
• Design and conduct early clinical development studies including phase 2a within planned timelines (supported by an operational team).
• Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.).
• Coordinate clinical team to set-up and follow the study.
• Ensure proper documentation is provided to the Ethics Committees and Health Authorities.
• Ensure that the study is scientifically sound and correctly conducted.
• Prepare and review the interim investigator reports.
• Lead the Dose Escalation Meeting and document decision making (for First-in-Human studies).
• Review the Adverse Event reports.
• Participate in the data review and validation meetings before database lock.
• Review and interpret the results.
• Prepare and distribute the Key Results Memo and prepare/review the Clinical Study Report.

Qualifications

• Solid Experience in the design and execution of early development clinical trials (phase 1a/b and 2a) and exploratory studies in pharmaceutical industry and/or in academic institution/hospital and/or in clinical site/CRO.
• Knowledge and mindset in translational research (Nice to Have).
• Experience in the conduct of late phase clinical trials (Nice to Have).

Education

• Mandatory Qualifications: Advanced degree: M.D. or M.D./Ph.D with at least 1-5 years of research experience; Postgraduate residency training; laboratory research in industry or academia; broad biomedical knowledge base; knowledge and mindset in translational research; ability to acquire and apply new technical skills.
• Nice to Have Qualifications: M.D./Ph.D. strongly preferred.

Skills

• Very good communication skills (verbal and written) for interactions across functional areas and with regulatory agencies.
• Demonstrated ability to challenge decisions and the status quo with a risk-management approach.
• Ability to work within a matrix organization across CPS, TMU, R&D and related functions.
• International/intercultural working skills.
• Open-minded to apply new digital and/or AI-driven solutions.
• Fluent in English.