Clinical Lead, Early Clinical and Experimental Therapeutics

Overview

Job Title: Clinical Lead, Early Clinical and Experimental Therapeutics

Location: Cambridge, MA, Morristown, NJ

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. This role is located within the Translational Medicine Unit (TMU)/Clinical and Patient Sciences (CPS) / Early Clinical and Experimental Therapeutics (ECET) and involves ECET contributions across all therapeutic areas, including small molecules, monoclonal antibodies, peptides, and gene therapies including nucleic acid modalities.

The Clinical Lead, ECET will translate preclinical development through early clinical development and beyond, collaborating with research scientists, toxicologists, pharmacokineticists, modelling & simulation experts, biomarker scientists, and late-phase clinicians to build an integrated translational medicine and human target validation plan.

• Participate in designing the early development plan and ECET plan, integrating into the overall development strategy in collaboration with the responsible Therapeutic Area research and development teams.
• Design safe, rapid, and informative First-In-Human studies including First-In-Patients, natural history studies, experimental model validation, mechanistic and signal-seeking approaches, and streamlined Proof-of-Mechanism and Proof-of-Concept studies for robust Go/No Go decisions and PK studies.
• Supervise execution and ensure close medical monitoring.
• Review, interpret results, and author ECET-related clinical documentation (informed consent forms, clinical protocols, study reports; abstracts and/or manuscripts as needed; components of investigator brochures and regulatory documents).
• Interact effectively with managers from various disciplines; serve as expert internal consultant on the assigned area and liaise with project partners.
• Participate in dose selection for First-In-Human studies and drive Go/No Go decisions when needed.
• Ensure adequate follow-up of studies and adherence to project timelines.
• Present data at appropriate meetings (internal and external to Sanofi).

• Serve as spokesperson for TMU and Clinical Patient Sciences, emphasizing strengths with a collaborative mindset.
• Engage with scientific challenges in early clinical development with a scientifically inquisitive, energetic, and proactive approach.
• Maintain Clinical Trial standards at the site and in collaboration with other clinical functions; demonstrate excellent communication and process management.
• Produce high-quality documents, requiring strong writing and communication skills.
• Manage aggressive timelines through cross-functional planning.
• Make front-line decisions on protocol design, execution, dose escalation, and safety information for regulatory authorities.

• Internal: TMU departments (Pre Clinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations and Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO), Regulatory Affairs, Patient Safety & Pharmacovigilance, Therapeutic Area R&D.
• External:
  Investigators, Clinical Site Services Providers, early-phase CROs, clinical trial vendors, clinical and scientific experts, key opinion leaders, ethics committees, Health Authority representatives.

At the clinical study level, the individual will also serve as Study Medical Manager (SMM) for selected clinical studies.

Duties include:

• Design and conduct early clinical development studies (phase 2a within planned timelines).
• Review and approve study documentation (monitoring plans, statistical analysis plans, contracts, regulatory documents, etc.).
• Coordinate the clinical team to set up and follow the study.
• Ensure proper documentation is provided to Ethics Committees and Health Authorities.

• Ensure 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.