Senior Clinical Research Director, I&I
Location: Cambridge, MA / Bridgewater, NJ
Employment: Permanent
Salary Range: USD 225,000 - 375,000
Posted on: Apr. 04, 2025
Closing on: Jul. 28, 2025
Company: Sanofi
Job Summary:
The Senior Clinical Research Director (Sr CRD) will serve as the primary clinical lead for programs in Immunology & Inflammation (I&I). This role demands a highly organized, strategic, and resourceful individual with excellent emotional intelligence, analytical skills, and the ability to manage multiple operational tasks. The Sr CRD will mentor other CRDs and Clinical Scientists and play a crucial role in defining clinical development strategies for projects.
Main Responsibilities:
Leadership & Mentorship:
Act as a mentor for other CRDs and Clinical Scientists on the same project/TA.
Coordinate with other CRDs and stakeholders to resolve project-related study issues, anticipating potential challenges and sharing lessons learned.
Medical Expertise:
Provide medical input for clinical studies, registries, and study documents (e.g., protocol, key results, Clinical Study Report).
Contribute to the clinical portion of submission dossiers, including Common Technical Documents for FDA & EMA submissions and responses to health authority questions.
Study & Data Oversight:
Review and/or contribute to clinical sections of documents such as Investigator’s brochures, INDs, DSURs, and RMPs.
Provide medical support for feasibility, study risk assessment, and medical review of data.
Prepare internal governance documents and presentations for key decision-making meetings.
Regulatory Engagement & Strategy:
Lead strategy for the clinical sections of the BLA/CTD, regulatory briefing packages, and regulatory meetings.
Represent the project at key regulatory agency meetings as the medical spokesperson.
Strategic Development & Product Value Proposition:
Contribute to defining the product value proposition (TVP), target product profile (TPP), and market access strategy.
Provide input on clinical development strategies to ensure alignment with business needs and research objectives.
Collaboration & Stakeholder Engagement:
Engage with research teams and external stakeholders to ensure alignment and provide clinical insights.
Contribute to the evaluation of potential in-licensing candidates for I&I therapeutic areas.
Minimum Qualifications:
Education:
Medical Doctor (MD) preferred (GP or specialist).
Fluent in English (both spoken and written).
Experience:
At least 4 years of experience in the pharmaceutical industry or CRO with a focus on clinical development.
Proven experience in leading clinical development strategies for immune-driven diseases.
Why Choose Us?
Growth Opportunities:
A dynamic and supportive team offering vast opportunities for career advancement, both locally and internationally.
Comprehensive Benefits:
A well-rounded rewards package including high-quality healthcare, wellness programs, and gender-neutral parental leave.
Diversity and Inclusion:
Sanofi is an Equal Opportunity and Affirmative Action employer, committed to a diverse workforce.
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