Senior Clinical Lead, Early Clinical & Experimental Therapeutics
Sanofi
10 days ago
Remote friendly (Morristown, NJ)
United States
$236,250 - $341,250 USD yearly
Clinical Research and Development
Main Responsibilities:
- Design safe, rapid, informative First-In-Human (FIH) oncology studies (incl. natural history, experimental model validation, mechanistic/signal-seeking, Proof-of-Mechanism/Proof-of-Concept) to support early Go/No-Go and pharmacokinetic decisions.
- Plan clinical development steps and integrate into overall development strategy; provide medical/clinical guidance for preclinical data generation/interpretation.
- Make front-line decisions on protocol design/execution, dose escalation, safety, and regulatory-facing information.
- Supervise clinical study execution; oversee and perform medical monitoring.
- Review/interpret results and author ECET-related documentation (consent forms, protocols, study reports; plus clinical pharmacology/ECET components of relevant documents).
- Coordinate oversight of CROs/outsourced activities; ensure cross-functional communication; lead dose escalation meeting; review adverse event reports; oversee safety monitoring.
- Participate in data review/validation; prepare Key Results Memo and Clinical Study Report.
Study Medical Manager (selected studies):
- Design and conduct FIH to phase 2a studies within timelines; review/approve study documents; coordinate setup/follow-up; ensure Ethics Committee/Health Authority documentation.
Qualifications (Education/Experience):
- M.D. or M.D./Ph.D.
- 3+ years clinical research experience (Phase 1/2a patient oversight and interpreting preclinical/biomarker data).
- Experience designing/executing early development/exploratory studies; leading cross-functional teams; medical safety oversight.
- Experience in translational/biomarker research and using emerging digital/AI tools.
Skills/Requirements:
- Biomedical knowledge; GCP knowledge; strong verbal/written communication; risk-management mindset; matrix working; international/intercultural collaboration.
Preferred:
- MD+PhD (or equivalent bench experience); global pharma experience; combination therapy/cytoplasmic signaling targets; late-phase trial experience.
Benefits (selected):
- Health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.
- Design safe, rapid, informative First-In-Human (FIH) oncology studies (incl. natural history, experimental model validation, mechanistic/signal-seeking, Proof-of-Mechanism/Proof-of-Concept) to support early Go/No-Go and pharmacokinetic decisions.
- Plan clinical development steps and integrate into overall development strategy; provide medical/clinical guidance for preclinical data generation/interpretation.
- Make front-line decisions on protocol design/execution, dose escalation, safety, and regulatory-facing information.
- Supervise clinical study execution; oversee and perform medical monitoring.
- Review/interpret results and author ECET-related documentation (consent forms, protocols, study reports; plus clinical pharmacology/ECET components of relevant documents).
- Coordinate oversight of CROs/outsourced activities; ensure cross-functional communication; lead dose escalation meeting; review adverse event reports; oversee safety monitoring.
- Participate in data review/validation; prepare Key Results Memo and Clinical Study Report.
Study Medical Manager (selected studies):
- Design and conduct FIH to phase 2a studies within timelines; review/approve study documents; coordinate setup/follow-up; ensure Ethics Committee/Health Authority documentation.
Qualifications (Education/Experience):
- M.D. or M.D./Ph.D.
- 3+ years clinical research experience (Phase 1/2a patient oversight and interpreting preclinical/biomarker data).
- Experience designing/executing early development/exploratory studies; leading cross-functional teams; medical safety oversight.
- Experience in translational/biomarker research and using emerging digital/AI tools.
Skills/Requirements:
- Biomedical knowledge; GCP knowledge; strong verbal/written communication; risk-management mindset; matrix working; international/intercultural collaboration.
Preferred:
- MD+PhD (or equivalent bench experience); global pharma experience; combination therapy/cytoplasmic signaling targets; late-phase trial experience.
Benefits (selected):
- Health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.