Senior Clinical Lead, Early Clinical & Experimental Therapeutics
Sanofi
10 days ago
Remote friendly (Cambridge, MA)
United States
$236,250 - $341,250 USD yearly
Clinical Research and Development
Main Responsibilities:
- Design safe, rapid, and informative First-In-Human (FIH) studies (including natural history, experimental model validation, mechanistic/signal-seeking; Proof-of-Mechanism and streamlined Proof-of-Concept) to enable early Go/No-Go decisions and PK studies.
- Plan and integrate steps of clinical development into overall development strategy with Therapeutic Areas.
- Provide medical/clinical expertise to guide preclinical data generation/interpretation.
- Make front-line decisions on protocol design/execution, dose escalation, safety, and regulatory-facing information.
- Supervise clinical study execution; oversee medical monitoring; review/interpret results and author ECET clinical documentation (e.g., consent forms, protocols, study reports, investigator brochures/regulatory components).
- Participate in dose selection for FIH; drive Go/No-Go; ensure follow-up and timeline adherence; maintain GCP/comms and high-quality documents.
- Coordinate CRO/outsourced activities, safety monitoring, interim investigator reports, and dose-escalation meetings; oversee AE review.
- Contribute to data review/validation, and prepare/distribute Key Results Memo and Clinical Study Report.
Qualifications (Required):
- M.D. or M.D./Ph.D.
- 3+ years clinical research experience (Phase 1/2a oversight + interpretation of preclinical/biomarker data).
- Experience designing/executing early development and exploratory studies in pharma and/or academic/clinical site/CRO.
- Cross-functional leadership; medical safety oversight; translational/biomarker experience; digital/AI tool experience.
- GCP knowledge; strong written/verbal communication; risk-management mindset; matrix working ability; international/intercultural skills.
- English.
Preferred:
- MD+PhD; global pharma experience; combination-therapy/cytoplasmic signaling pathways experience; residency and lab research; late-phase trial experience.
Benefits (explicit):
- Health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.
- Design safe, rapid, and informative First-In-Human (FIH) studies (including natural history, experimental model validation, mechanistic/signal-seeking; Proof-of-Mechanism and streamlined Proof-of-Concept) to enable early Go/No-Go decisions and PK studies.
- Plan and integrate steps of clinical development into overall development strategy with Therapeutic Areas.
- Provide medical/clinical expertise to guide preclinical data generation/interpretation.
- Make front-line decisions on protocol design/execution, dose escalation, safety, and regulatory-facing information.
- Supervise clinical study execution; oversee medical monitoring; review/interpret results and author ECET clinical documentation (e.g., consent forms, protocols, study reports, investigator brochures/regulatory components).
- Participate in dose selection for FIH; drive Go/No-Go; ensure follow-up and timeline adherence; maintain GCP/comms and high-quality documents.
- Coordinate CRO/outsourced activities, safety monitoring, interim investigator reports, and dose-escalation meetings; oversee AE review.
- Contribute to data review/validation, and prepare/distribute Key Results Memo and Clinical Study Report.
Qualifications (Required):
- M.D. or M.D./Ph.D.
- 3+ years clinical research experience (Phase 1/2a oversight + interpretation of preclinical/biomarker data).
- Experience designing/executing early development and exploratory studies in pharma and/or academic/clinical site/CRO.
- Cross-functional leadership; medical safety oversight; translational/biomarker experience; digital/AI tool experience.
- GCP knowledge; strong written/verbal communication; risk-management mindset; matrix working ability; international/intercultural skills.
- English.
Preferred:
- MD+PhD; global pharma experience; combination-therapy/cytoplasmic signaling pathways experience; residency and lab research; late-phase trial experience.
Benefits (explicit):
- Health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.