Clinical Research Director - Immunology and Inflammation
Sanofi
August 06, 2026
Remote friendly (Cambridge, MA)
United States
$206,250 - $343,750 USD yearly
Clinical Research and Development
Responsibilities:
- Develop, execute, and report clinical trials for product registration (Solid Organ Transplant; Immunology & Inflammation TA), reporting to the Clinical Lead.
- Develop abbreviated protocols and clinical protocols; participate in reviews for protocols, study reports, and labeling.
- Support interactions with regulatory agencies and ethics committees; represent the division as medical spokesperson at key regulatory meetings.
- Contribute to clinical strategy and plan; represent clinical function on Clinical Study Teams and other teams.
- Provide input to the Translational Medicine Plan (biomarker strategy).
- Ensure timely development activities (protocols before study start; committee management/centralized monitoring; KRM & CSR preparation).
- Interact with opinion leaders and external consultants; serve as medical monitor for assigned studies.
- Ensure clinical data meets regulatory standards; support registrations and label submissions/modifications (IB, DSUR, Health Authority briefing package) and Advisory Committee preparation.
- Ensure timely submission/dissemination of clinical data; support advisory board planning; establish/maintain collaborations with knowledge experts.
Qualifications/Skills:
- Medical Doctor with transplant, nephrology, hepatology, or immunology clinical expertise preferred.
- Minimum 2 years’ experience in pharmaceutical drug development and/or clinical research.
- Deep transplant/immunology understanding; strong scientific/academic background; critical appraisal of medical literature.
- Demonstrated clinical development track record (Phase 3 advantage); knowledge of drug development and immunology (antibody knowledge plus).
- Strong analytical skills; self-starting, creative, well-organized, strategic, resourceful; excellent emotional intelligence.
- Ability to operate independently and in matrix teams (onsite/remote); strong communication/presentation/negotiation skills; fluent in English.
Benefits:
- Healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Develop, execute, and report clinical trials for product registration (Solid Organ Transplant; Immunology & Inflammation TA), reporting to the Clinical Lead.
- Develop abbreviated protocols and clinical protocols; participate in reviews for protocols, study reports, and labeling.
- Support interactions with regulatory agencies and ethics committees; represent the division as medical spokesperson at key regulatory meetings.
- Contribute to clinical strategy and plan; represent clinical function on Clinical Study Teams and other teams.
- Provide input to the Translational Medicine Plan (biomarker strategy).
- Ensure timely development activities (protocols before study start; committee management/centralized monitoring; KRM & CSR preparation).
- Interact with opinion leaders and external consultants; serve as medical monitor for assigned studies.
- Ensure clinical data meets regulatory standards; support registrations and label submissions/modifications (IB, DSUR, Health Authority briefing package) and Advisory Committee preparation.
- Ensure timely submission/dissemination of clinical data; support advisory board planning; establish/maintain collaborations with knowledge experts.
Qualifications/Skills:
- Medical Doctor with transplant, nephrology, hepatology, or immunology clinical expertise preferred.
- Minimum 2 years’ experience in pharmaceutical drug development and/or clinical research.
- Deep transplant/immunology understanding; strong scientific/academic background; critical appraisal of medical literature.
- Demonstrated clinical development track record (Phase 3 advantage); knowledge of drug development and immunology (antibody knowledge plus).
- Strong analytical skills; self-starting, creative, well-organized, strategic, resourceful; excellent emotional intelligence.
- Ability to operate independently and in matrix teams (onsite/remote); strong communication/presentation/negotiation skills; fluent in English.
Benefits:
- Healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.