Clinical Lead, Early Clinical and Experimental Therapeutics (ECET)
📍 Location: Morristown, New Jersey / Cambridge, Massachusetts
💰 Salary Range: USD 201,000 – 290,333 per year
🏢 Company: Sanofi
🌐 Work Type: Onsite / Hybrid
About Sanofi
Sanofi is a global healthcare company driven by one purpose — to chase the miracles of science to improve people’s lives.
Working at the intersection of deep immunoscience, AI-powered discovery, and translational medicine, Sanofi focuses on transforming early-stage scientific ideas into real-world healthcare breakthroughs.
Our teams collaborate across oncology, rare diseases, neurology, and vaccines, pushing scientific boundaries while nurturing personal and professional growth.
Position Overview
As a Clinical Lead in Early Clinical and Experimental Therapeutics (ECET), you will play a pivotal role in bridging preclinical discovery with early clinical development, driving rapid Proof-of-Mechanism and Proof-of-Concept studies.
This role, part of the Translational Medicine Unit (TMU) within Clinical and Patient Sciences (CPS), oversees the design, execution, and interpretation of early-phase clinical trials involving small molecules, monoclonal antibodies, peptides, gene therapies, and nucleic acid modalities.
You will collaborate with multidisciplinary teams to advance innovative therapies from research to human application — ensuring scientific excellence, patient safety, and timely project delivery.
Main Responsibilities
Strategic & Scientific Leadership
Lead ECET contributions from preclinical through early clinical development.
Design and implement First-in-Human, Proof-of-Mechanism, Proof-of-Concept, natural history, and experimental model validation studies.
Integrate translational medicine strategies to evaluate pharmacology, safety, and efficacy signals.
Contribute to Human Target Validation (HTV) efforts by translating preclinical findings into clinical hypotheses.
Clinical Study Oversight
Supervise the execution and medical monitoring of early clinical studies (Phase 1a/b, 2a).
Review and approve key study documents: clinical protocols, informed consent forms, study reports, and regulatory submissions.
Oversee dose-escalation decisions, safety assessments, and Go/No-Go evaluations.
Ensure alignment with ethical standards and regulatory expectations.
Cross-Functional Collaboration
Partner with internal teams across TMU, Regulatory Affairs, Preclinical Safety, and Quantitative Pharmacology.
Liaise with external stakeholders including CROs, investigators, clinical sites, KOLs, and Health Authorities.
Present findings and recommendations in internal and external scientific meetings.
Documentation and Communication
Author and review ECET-related documents (study protocols, reports, investigator brochures).
Communicate complex scientific and clinical findings clearly to diverse audiences.
Ensure clinical documentation meets regulatory, ethical, and scientific standards.
Major Challenges and Opportunities
Serve as a spokesperson for Translational Medicine and Clinical Patient Sciences.
Lead scientific problem-solving in complex early-phase development settings.
Manage aggressive project timelines while maintaining data integrity and clinical standards.
Act as a change leader to integrate digital and AI-driven solutions in early clinical research.
Decision-Making Authority
Make key decisions on study design, dose escalation, safety management, and regulatory communications.
Drive Go/No-Go recommendations for early development programs.
Internal & External Relationships
Internal:
Translational Medicine Unit departments (Preclinical Safety, Laboratory Sciences, Quantitative Pharmacology)
Early Development Clinical Operations (EDCO), Regulatory Affairs, Pharmacovigilance, and R&D groups
External:
Investigators, CROs, clinical vendors, ethics committees, Health Authorities, KOLs
About You
Education
🎓 Mandatory:
M.D. or M.D./Ph.D. with at least 1–5 years of research experience
Postgraduate residency training in clinical or biomedical research
🎓 Preferred:
M.D./Ph.D. strongly preferred
Experience
✅ Required:
Proven experience designing and executing early development (Phase 1a/b, 2a) and exploratory trials in pharma, CRO, or academic settings.
✅ Preferred:
Knowledge of translational research and experience in late-phase clinical development.
Skills
Strong understanding of clinical pharmacology and translational medicine principles.
Excellent communication (verbal & written) and scientific writing abilities.
Strong leadership and collaboration skills within a matrix, multicultural environment.
Comfortable applying digital tools and AI-based research approaches.
Fluent in English.
Why Choose Sanofi
✨ Innovate with Purpose: Work on pioneering therapies across multiple therapeutic areas.
🚀 Grow Without Limits: Opportunities for global mobility, leadership, and lateral growth.
💼 Comprehensive Rewards:
Competitive salary & performance-based bonuses
Health, wellness, and prevention programs
At least 14 weeks of gender-neutral parental leave
🌍 Inclusive Culture: Equal opportunity employer embracing diversity and equity.
Equal Opportunity Statement
Sanofi and its U.S. affiliates are Equal Opportunity and Affirmative Action Employers.
All qualified applicants receive consideration without regard to race, color, ancestry, religion, gender, sexual orientation, national origin, disability, or veteran status.
How to Apply
🔗 Apply via Sanofi Careers
📺 Watch: “One Day at Sanofi” and explore our Diversity, Equity & Inclusion initiatives.
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