Senior Clinical Lead, Early Clinical & Experimental Therapeutics
Sanofi
August 23, 2026
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 studies (including natural history, experimental model validation, mechanistic/signal-seeking, Proof-of-Mechanism/Proof-of-Concept, and PK studies) for oncology assets.
- Participate in planning steps of clinical development and integrate 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 regulatory interactions.
- Supervise clinical study execution; oversee and perform medical monitoring.
- Review/interpret results and author ECET-related clinical documentation (ICFs, protocols, study reports; ECET/regional components of investigator brochures and regulatory documents).
- Drive dose selection for FIH studies and Go/No-Go decisions; ensure follow-up and timelines.
- Maintain GCP standards; manage aggressive timelines; collaborate with investigators and external experts; present data at meetings.
Study Medical Manager (SMM) duties (selected studies):
- Design/conduct FIH to phase 2a studies within timelines; review/approve key documents; coordinate setup and documentation for Ethics Committees/Health Authorities.
- Ensure study scientific conduct, oversee CROs, lead dose escalation meetings, review AEs, and safety monitoring.
- Participate in data review pre-database lock; prepare Key Results Memo and Clinical Study Report.
Qualifications:
- Education: M.D. or M.D./Ph.D.
- Experience: 3+ years clinical research (oversight of Phase 1/2a patients + interpretation of preclinical/biomarker data); experience designing/executing early development trials; lead cross-functional teams; medical safety oversight; translational/biomarker work; use of digital/AI tools.
- Skills: biomedical knowledge for nonclinical/clinical experiments; GCP; strong verbal/written communication; risk-management mindset; matrix organization; international/intercultural collaboration.
- Language: English.
Preferred:
- MD+PhD (or equivalent bench experience); global pharma; combination therapy and cytoplasmic signaling targets; residency/lab research in industry/academia; late-phase trial experience.
Benefits (explicitly stated):
- Health and wellbeing benefits including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Design safe, rapid, and informative First-In-Human studies (including natural history, experimental model validation, mechanistic/signal-seeking, Proof-of-Mechanism/Proof-of-Concept, and PK studies) for oncology assets.
- Participate in planning steps of clinical development and integrate 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 regulatory interactions.
- Supervise clinical study execution; oversee and perform medical monitoring.
- Review/interpret results and author ECET-related clinical documentation (ICFs, protocols, study reports; ECET/regional components of investigator brochures and regulatory documents).
- Drive dose selection for FIH studies and Go/No-Go decisions; ensure follow-up and timelines.
- Maintain GCP standards; manage aggressive timelines; collaborate with investigators and external experts; present data at meetings.
Study Medical Manager (SMM) duties (selected studies):
- Design/conduct FIH to phase 2a studies within timelines; review/approve key documents; coordinate setup and documentation for Ethics Committees/Health Authorities.
- Ensure study scientific conduct, oversee CROs, lead dose escalation meetings, review AEs, and safety monitoring.
- Participate in data review pre-database lock; prepare Key Results Memo and Clinical Study Report.
Qualifications:
- Education: M.D. or M.D./Ph.D.
- Experience: 3+ years clinical research (oversight of Phase 1/2a patients + interpretation of preclinical/biomarker data); experience designing/executing early development trials; lead cross-functional teams; medical safety oversight; translational/biomarker work; use of digital/AI tools.
- Skills: biomedical knowledge for nonclinical/clinical experiments; GCP; strong verbal/written communication; risk-management mindset; matrix organization; international/intercultural collaboration.
- Language: English.
Preferred:
- MD+PhD (or equivalent bench experience); global pharma; combination therapy and cytoplasmic signaling targets; residency/lab research in industry/academia; late-phase trial experience.
Benefits (explicitly stated):
- Health and wellbeing benefits including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.