Senior Clinical Lead, Early Clinical & Experimental Therapeutics
Sanofi
August 21, 2026
On-site
Morristown, NJ
$236,250 - $341,250 USD yearly
Clinical Research and Development
Responsibilities:
- Design safe, rapid, informative First-In-Human studies (incl. natural history, experimental model validation, mechanistic/signal-seeking, streamlined PoM/PoC) to support early Go/No-Go decisions and PK studies.
- Integrate clinical development steps into overall development strategy; provide medical/clinical expertise to guide preclinical data generation and interpretation.
- Make front-line decisions on protocol design, execution, dose escalation, safety, and information for Regulatory authorities.
- Supervise clinical study execution; oversee and perform medical monitoring.
- Review/interpret results and author ECET-related clinical documentation (ICFs, protocols, study reports, clinical pharmacology/ECET components of investigator brochures, regulatory documents).
- Participate in dose selection and drive Go/No-Go; ensure follow-up and timelines; ensure GCP/clinical trial standards.
- Maintain collaborations; coordinate CRO/outsourced oversight; lead dose escalation meetings; review AE reports; coordinate cross-functional communication.
- Participate in data review/validation; prepare Key Results Memo and Clinical Study Report.
Study Medical Manager (SMM) (selected studies):
- Design and conduct FIH to phase 2a studies; review/approve study documentation; coordinate team setup; ensure documentation to Ethics Committees/Health Authorities.
Qualifications:
- Education: M.D. or M.D./Ph.D.
- Experience: 3+ years clinical research incl. early (Phase 1/2a) patient oversight and interpretation of preclinical/biomarker data; design/execution of phase 1/2a and exploratory studies in pharma/academic/CRO settings; lead cross-functional teams; medical safety oversight; translational/biomarker research; use digital/AI tools.
Skills/Requirements:
- Biomedical knowledge to design/interpret nonclinical and clinical experiments; GCP knowledge; excellent verbal/written communication; risk-management mindset; matrix organization ability; international/intercultural working skills; challenge decisions.
Preferred:
- MD + PhD; global pharma experience; combination therapy and cytoplasmic signaling pathway drugs; residency/lab research; late-phase trial experience.
Benefits (explicit):
- High-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Design safe, rapid, informative First-In-Human studies (incl. natural history, experimental model validation, mechanistic/signal-seeking, streamlined PoM/PoC) to support early Go/No-Go decisions and PK studies.
- Integrate clinical development steps into overall development strategy; provide medical/clinical expertise to guide preclinical data generation and interpretation.
- Make front-line decisions on protocol design, execution, dose escalation, safety, and information for Regulatory authorities.
- Supervise clinical study execution; oversee and perform medical monitoring.
- Review/interpret results and author ECET-related clinical documentation (ICFs, protocols, study reports, clinical pharmacology/ECET components of investigator brochures, regulatory documents).
- Participate in dose selection and drive Go/No-Go; ensure follow-up and timelines; ensure GCP/clinical trial standards.
- Maintain collaborations; coordinate CRO/outsourced oversight; lead dose escalation meetings; review AE reports; coordinate cross-functional communication.
- Participate in data review/validation; prepare Key Results Memo and Clinical Study Report.
Study Medical Manager (SMM) (selected studies):
- Design and conduct FIH to phase 2a studies; review/approve study documentation; coordinate team setup; ensure documentation to Ethics Committees/Health Authorities.
Qualifications:
- Education: M.D. or M.D./Ph.D.
- Experience: 3+ years clinical research incl. early (Phase 1/2a) patient oversight and interpretation of preclinical/biomarker data; design/execution of phase 1/2a and exploratory studies in pharma/academic/CRO settings; lead cross-functional teams; medical safety oversight; translational/biomarker research; use digital/AI tools.
Skills/Requirements:
- Biomedical knowledge to design/interpret nonclinical and clinical experiments; GCP knowledge; excellent verbal/written communication; risk-management mindset; matrix organization ability; international/intercultural working skills; challenge decisions.
Preferred:
- MD + PhD; global pharma experience; combination therapy and cytoplasmic signaling pathway drugs; residency/lab research; late-phase trial experience.
Benefits (explicit):
- High-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.