Clinical Research Director - Immunology and Inflammation
Sanofi
11 days ago
Remote friendly (Morristown, NJ)
United States
$206,250 - $343,750 USD yearly
Clinical Research and Development
Clinical Research Director (CRD), Immunology and Inflammation (Solid Organ Transplant)
Responsibilities:
- Develop, execute, and report clinical trials in support of product registration; report to the Clinical Lead responsible for clinical strategy.
- Develop Abbreviated Protocols and clinical protocols; participate in review of protocols, study reports, and labeling.
- Contribute to interactions with regulatory agencies and ethics committees.
- Contribute to development of the clinical strategy and plan.
- Provide input into the Translational Medicine Plan (biomarker strategy and drug pathway/effects knowledge).
- Ensure timely execution (protocol/abbreviated protocol before study start; committees management and centralized monitoring during study; KRM & CSR preparation at study end).
- Represent the clinical function on Clinical Study Teams and other teams as appropriate.
- Interact with opinion leaders and external consultants; serve as medical monitor for assigned studies.
- Represent the division at key regulatory meetings; ensure clinical data meets regulatory standards.
- Support registrations and label submissions/modifications (IB, DSUR, Briefing Package).
- Participate in Advisory Committee preparation.
- Ensure timely submission and dissemination of clinical data; support planning advisory boards.
- Establish and maintain collaborations with knowledge experts.
Qualifications:
- MD with transplant, nephrology, hepatology, or immunology clinical expertise preferred.
- Minimum 2 years’ experience in pharmaceutical drug development and/or clinical research.
- Phase 3 clinical development experience (advantage).
- Strong scientific/academic background; deep disease understanding.
- Proven scientific achievement (presentations/publications and/or major studies/submissions) (plus).
- Knowledge of drug development and immunology.
- Good networking in cross-cultural environments.
- Strong interpersonal, communication, presentation, and negotiation skills.
- Performance-oriented; able to work to agreed timelines and execute strategy.
- Fluent English (verbal/written).
Benefits (if applicable):
- Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs; at least 14 weeks’ gender-neutral parental leave.
Responsibilities:
- Develop, execute, and report clinical trials in support of product registration; report to the Clinical Lead responsible for clinical strategy.
- Develop Abbreviated Protocols and clinical protocols; participate in review of protocols, study reports, and labeling.
- Contribute to interactions with regulatory agencies and ethics committees.
- Contribute to development of the clinical strategy and plan.
- Provide input into the Translational Medicine Plan (biomarker strategy and drug pathway/effects knowledge).
- Ensure timely execution (protocol/abbreviated protocol before study start; committees management and centralized monitoring during study; KRM & CSR preparation at study end).
- Represent the clinical function on Clinical Study Teams and other teams as appropriate.
- Interact with opinion leaders and external consultants; serve as medical monitor for assigned studies.
- Represent the division at key regulatory meetings; ensure clinical data meets regulatory standards.
- Support registrations and label submissions/modifications (IB, DSUR, Briefing Package).
- Participate in Advisory Committee preparation.
- Ensure timely submission and dissemination of clinical data; support planning advisory boards.
- Establish and maintain collaborations with knowledge experts.
Qualifications:
- MD with transplant, nephrology, hepatology, or immunology clinical expertise preferred.
- Minimum 2 years’ experience in pharmaceutical drug development and/or clinical research.
- Phase 3 clinical development experience (advantage).
- Strong scientific/academic background; deep disease understanding.
- Proven scientific achievement (presentations/publications and/or major studies/submissions) (plus).
- Knowledge of drug development and immunology.
- Good networking in cross-cultural environments.
- Strong interpersonal, communication, presentation, and negotiation skills.
- Performance-oriented; able to work to agreed timelines and execute strategy.
- Fluent English (verbal/written).
Benefits (if applicable):
- Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs; at least 14 weeks’ gender-neutral parental leave.