Clinical Lead, Early Clinical and Experimental Therapeutics

Role Summary

Clinical Lead, Early Clinical and Experimental Therapeutics (ECET) in Translational Medicine Unit, responsible for ECET contributions across therapeutic areas including small molecules, monoclonal antibodies, peptides, and gene therapy modalities. Drives translation from preclinical development through early clinical development and beyond, enabling early Proof-of-Mechanism/Proof-of-Concept, natural history studies, and human target validation, with cross-functional collaboration to integrate outputs into a coherent translational plan. Location: Cambridge, MA; Morristown, NJ.

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 studies, 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).

Qualifications

• Required: 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 institutions/hospitals and/or in clinical site/CRO.
• Preferred: Knowledge and mindset in translational research; experience in the conduct of late-phase clinical trials.

Education

• Mandatory: Advanced degree (MD or MD/PhD) with at least 1–5 years of research experience; postgraduate residency training; laboratory research in industry or academia; broad biomedical knowledge; ability to acquire/apply new technical skills; knowledge/mindset in translational research.
• Preferred: MD/PhD strongly preferred.

Skills

• Very good communication skills (verbal and written) for interactions across functional areas and with regulatory agencies.
• Demonstrated capability 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 beyond (e.g., Medical).
• International/intercultural working skills.
• Open-minded to apply new digital and/or AI-driven solutions.
• Languages: fluent in English.