Job Title:
Clinical Lead, Early Clinical and Experimental Therapeutics (ECET)
Location:
Cambridge, MA
Morristown, NJ
About the Job
Sanofi is accelerating drug discovery and development to deliver answers faster to patients and families. As a Clinical Lead, ECET, you will play a key role in bridging preclinical research and early clinical development, designing and executing innovative trials that generate rapid, reliable insights.
This role sits within:
Translational Medicine Unit (TMU)
Clinical and Patient Sciences (CPS)
Early Clinical and Experimental Therapeutics (ECET)
Scope includes:
Small molecules, monoclonal antibodies, peptides, gene therapy, and nucleic acid modalities.
Early & rapid Proof-of-Mechanism/Proof-of-Concept (PoM/PoC) studies.
Natural history studies and experimental model validation.
Human Target Validation (HTV).
Mechanistic and signal-seeking clinical trials.
You will work cross-functionally with research scientists, toxicologists, pharmacokineticists, modelers, biomarker experts, and therapeutic area clinicians to integrate data into translational medicine strategies.
Main Responsibilities
At the project level (as part of the Translational Medicine Subteam):
Contribute to early development and ECET plans, integrating them into the overall development strategy.
Design and oversee studies:
First-in-Human (FIH) & First-in-Patient.
Natural history & mechanistic studies.
Signal-seeking, PoM, and PoC studies.
Pharmacokinetic studies.
Ensure safe, rapid, and informative study designs that support early Go/No Go decisions.
Supervise execution and provide close medical monitoring.
Author/review ECET documentation: clinical protocols, ICFs, study reports, IB components, regulatory documents.
Participate in dose selection for FIH studies.
Present data internally and externally (scientific meetings, regulatory discussions).
Ensure compliance with timelines and clinical trial standards.
Study Medical Manager (SMM) Responsibilities
Study Preparation
Design and conduct early clinical development studies (up to Phase 2a).
Review/approve key documents: monitoring plan, SAP, contracts, regulatory filings.
Coordinate clinical team for study setup.
Provide documentation to Ethics Committees and Health Authorities.
Study Conduct
Ensure studies are scientifically sound and compliant.
Review AE reports, interim results, and investigator communications.
Lead Dose Escalation Meetings for FIH studies.
Study Validation & Reporting
Participate in data review and validation before database lock.
Interpret results and prepare Key Results Memos & Clinical Study Reports.
Major Challenges & Opportunities
Act as spokesperson for TMU and CPS.
Address scientific challenges in early clinical development.
Manage aggressive timelines through cross-functional planning.
Ensure high-quality clinical documents and communications.
Make front-line decisions on protocol design, safety, dose escalation, and regulatory interactions.
Key Relationships
Internal:
TMU departments (PreClinical Safety, Laboratory Sciences, Quantitative Pharmacology, Evidence Generation & Decision Science).
Early Development Clinical Operations (EDCO).
Regulatory Affairs.
Patient Safety & Pharmacovigilance.
Therapeutic Area R&D groups.
External:
Investigators & CROs.
Clinical site service providers & vendors.
KOLs & scientific experts.
Ethics Committees & Health Authorities.
About You
Education & Training
Mandatory:
M.D. or M.D./Ph.D. with 1–5 years research experience.
Postgraduate residency training.
Broad biomedical knowledge.
Experience in laboratory/clinical research.
Translational research mindset.
Preferred:
M.D./Ph.D. strongly preferred.
Experience
Mandatory:
Solid experience in early clinical development trials (Phases 1a/b, 2a).
Experience with exploratory/proof-of-concept studies.
Preferred:
Knowledge of translational research.
Experience in late-phase trials.
Skills
Excellent communication (written & verbal).
Strong clinical document writing skills.
Ability to challenge decisions with risk-management approach.
Experience working in matrix organizations.
Cross-cultural collaboration.
Open to digital/AI-driven solutions in clinical development.
Strong organizational and decision-making ability.
Languages: Fluent English required.
Why Choose Us?
Be part of a future-focused team driving innovation in clinical development.
Endless opportunities for career growth (promotions, international moves).
Competitive rewards & benefits package.
At least 14 weeks’ gender-neutral parental leave.
Supportive, inclusive, and diverse work culture.
Equal Opportunity
Sanofi is an Equal Opportunity and Affirmative Action Employer. All applicants will be considered regardless of race, color, religion, sex, gender identity, age, nationality, disability, veteran status, or other protected categories.
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