Senior Clinical Lead, Early Clinical & Experimental Therapeutics
Listed on 2026-07-07
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Research/Development
Clinical Research, Research Scientist
Senior Clinical Lead, Early Clinical & Experimental Therapeutics
Location:
Cambridge, MA / Morristown, NJ
The Senior Clinical Lead will design and lead early clinical development of oncology assets—small molecules, monoclonal antibodies, antibody‑drug conjugates, and immune cell engagers—within the Translational Medicine Unit’s Clinical Patient Services Team. The role supports the Global Early Clinical and Experimental Therapeutics Oncology Team and collaborates across global asset teams, translational medicine sub‑teams, and development disease area groups from preclinical through Phase 2a.
Key focus includes rapid proof‑of‑mechanism, natural history studies, experimental model validation, human target validation, and signal‑seeking clinical and mechanistic trials.
- Design safe, rapid, and informative First‑In‑Human studies, including natural history, experimental model validation, mechanistic, and signal‑seeking studies.
- Develop and integrate clinical development plans into the overall strategy in collaboration with Therapeutic Area leaders.
- Provide medical/clinical expertise to guide pre‑clinical data generation, interpretation, and translational research for oncology assets.
- Make protocol‑design, dose‑escalation, safety, and regulatory decisions; supervise study execution and medical monitoring.
- Write and review ECET‑related clinical documentation, including informed consent, protocols, study reports, abstracts, manuscripts, and regulatory submissions.
- Lead dose‑selection for First‑In‑Human studies and drive Go/No‑Go decisions.
- Maintain clinical trial standards, manage timelines, and ensure effective cross‑functional collaboration.
- Serve as Study Medical Manager for selected studies, overseeing study preparation, conduct, safety monitoring, and reporting.
- Advanced degree: MD or MD/PhD.
- Minimum three years of experience overseeing early (Phase 1/2a) clinical trials and interpreting pre‑clinical/biomarker data.
- Experience designing and executing early development trials (Phase 1/2a) and exploratory studies in industry, academia, or CRO settings.
- Demonstrated leadership of cross‑functional teams and medical safety oversight.
- Knowledge of translational/biomarker research and emerging digital/AI‑driven tools.
- Strong communication skills, risk‑management mindset, and ability to work within a matrix organization.
- Fluent in English.
- MD + PhD or equivalent bench science experience.
- Experience with combination therapies and cytoplasmic signaling pathways.
- Postgraduate residency training and laboratory research in industry or academia.
- Experience conducting late‑phase clinical trials.
- Salary range: $236,250 – $341,250.
- Benefits include comprehensive health coverage, wellness programs, and at least 14 weeks of gender‑neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity Employers committed to a culturally inclusive workforce. All qualified applicants will be considered for employment without regard to race, color, creed, religion, national origin, age, ancestry, marital status, gender identity or expression, sexual orientation, disability, veteran or military status, or any other characteristic protected by law.
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