🔬 Job Title: Clinical Lead, Early Clinical and Experimental Therapeutics (ECET)
Locations: Morristown, New Jersey / Cambridge, Massachusetts, USA
Salary Range: USD 201,000 – 290,333 per year
Company: Sanofi
Department: Translational Medicine Unit (TMU) / Clinical and Patient Sciences (CPS)
🧬 About the Role
As a Clinical Lead – ECET, you will drive the translation of preclinical discoveries into early clinical development, focusing on early Proof-of-Mechanism (PoM) and Proof-of-Concept (PoC) studies. This position plays a critical role in connecting research and clinical science to accelerate drug discovery and development.
You’ll collaborate across multiple therapeutic areas including oncology, rare diseases, neurology, and vaccines, working closely with scientists, clinicians, and data experts to generate human data that guides Go/No-Go decisions.
⚙️ Key Responsibilities
1. Strategy & Planning
Participate in designing early development plans and ECET strategies.
Develop First-In-Human (FIH), First-In-Patient, and exploratory study designs.
Integrate ECET plans into overall therapeutic development strategies.
2. Study Design & Execution
Design and oversee Phase 1a/b and 2a clinical trials and exploratory studies.
Supervise clinical execution and ensure continuous medical monitoring.
Drive dose selection, early Go/No-Go decision-making, and study progress tracking.
3. Data & Documentation
Review and interpret clinical results.
Author and approve key clinical documents (protocols, study reports, ICFs, IBs).
Present findings at internal and external scientific meetings.
4. Cross-Functional Collaboration
Liaise with internal departments: Preclinical Safety, Quantitative Pharmacology, Evidence Generation, Clinical Operations, Regulatory Affairs, and PV.
Interact with external partners: CROs, investigators, KOLs, ethics committees, and regulatory authorities.
5. Study Medical Management (SMM)
Lead preparation and conduct of early clinical trials.
Review AE reports and oversee dose escalation meetings.
Validate and report results post-study completion.
🧠 Major Challenges & Opportunities
Acting as a scientific spokesperson for Translational Medicine.
Managing complex timelines and multidisciplinary inputs.
Maintaining clinical and regulatory standards.
Contributing to innovative and AI-driven research solutions.
🎓 Qualifications
Mandatory
Education: M.D. or M.D./Ph.D.
Experience: 1–5 years in early development (Phase 1/2a) or exploratory clinical trials.
Training: Postgraduate residency or relevant laboratory research (academic/industry).
Strong biomedical knowledge base and translational research mindset.
Preferred
M.D./Ph.D. strongly preferred.
Experience in late-phase clinical trials.
Exposure to digital or AI-powered clinical tools.
💬 Skills
Excellent communication and scientific writing skills.
Ability to work in matrix, cross-functional teams.
Decision-making and risk management under tight timelines.
Culturally adaptable and internationally collaborative.
Fluent in English (mandatory).
🤝 Key Internal/External Relationships
Internal:
TMU departments (PreClinical Safety, Laboratory Sciences, Quantitative Pharmacology, etc.)
Early Development Clinical Operations (EDCO), Regulatory Affairs, PV, R&D groups
External:
Investigators, CROs, KOLs, vendors, ethics committees, and regulatory authorities
🌟 Why Work with Sanofi
Collaborate across cutting-edge fields in immunoscience and AI innovation.
Grow within a global, diverse, and inclusive organization.
Competitive compensation and benefits including:
Comprehensive healthcare
Wellness programs
14 weeks of gender-neutral parental leave
Global mobility and career growth opportunities.
🧭 Job Category
Clinical Research / Translational Medicine / Early Development (Phase 1–2a)
(Also relevant to Medical Affairs, Clinical Pharmacology, and Drug Discovery Integration)
🏢 About Sanofi
Sanofi is a global healthcare leader dedicated to chasing the miracles of science to improve lives. We focus on transformative therapies across immunology, oncology, rare diseases, vaccines, and neuroscience.
🌐 Visit: www.sanofi.com
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