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Clinical Research Director

5+ years
Not Disclosed
10 April 22, 2025
Job Description
Job Type: Full Time Education: MD/DO Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Director
Location: Cambridge, MA & Bridgewater, NJ
Employment: Permanent
Salary Range: USD 201,000 - 290,333
Posted on: Apr. 02, 2025
Closing on: Jun. 23, 2025
Company: Sanofi

Job Summary:
The Clinical Research Director (CRD) for Immunology & Inflammation (I&I) Therapeutic Area at Sanofi will lead the clinical development strategy for assets in Gastroenterology. The CRD will collaborate closely with cross-functional teams to design and execute clinical trials, while driving scientific innovation and advancing knowledge in immunology and gastroenterology.

Main Responsibilities:

  • Clinical Development Strategy:

    • Develop and document the clinical development plan (CDP) for one or more assets, ensuring alignment with project strategy and collaborating with global project teams and internal stakeholders (clinical operations, translational medicine, regulatory affairs, etc.).

    • Lead a clinical subteam to design clinical studies and create clinical study protocols.

  • Study Execution and Compliance:

    • Oversee the execution of clinical studies, ensuring compliance with SOPs, GCP, ICH guidelines, and other regulations.

    • Review essential documents, including Investigator’s brochures, regulatory documents, and clinical development plans.

  • Regulatory Support:

    • Support the drug registration process by contributing to submission dossiers and preparing for advisory committees.

    • Represent Clinical Development in Health Authority meetings, incorporating feedback into the development strategy.

  • Data Review and Interpretation:

    • Contribute to data analysis, interpretation, and publication of clinical study results.

  • External Scientific Collaboration:

    • Establish and maintain interactions with external scientific and clinical communities, incorporating insights into the program.

    • Align clinical strategy with partners in alliance projects and assess business development opportunities.

  • Leadership and Ethical Standards:

    • Lead with integrity and uphold high ethical standards in clinical research.

    • Provide scientific leadership in gastroenterology and translational medicine.

Scientific and Technical Expertise:

  • Requirements:

    • Medical Doctor, board-certified or equivalent in gastroenterology or allergy/immunology.

    • 5+ years of clinical experience in gastroenterology.

    • Strong scientific background in clinical research, pharmaceutical experience, or experimental medicine in the therapeutic area.

    • Proficient in clinical pharmacology, biomarkers, clinical trial designs, and statistical methods.

    • Excellent problem-solving, decision-making, and communication skills.

About You:

  • Qualifications:

    • Medical degree (MD), board certification or equivalent in gastroenterology or allergy/immunology.

    • 5+ years of clinical experience within gastroenterology.

    • Strong academic and scientific background in clinical research and drug development.

    • Exceptional interpersonal, presentation, and leadership skills.

    • Fluent in English (verbal and written communication).

Why Choose Us?

  • Growth Opportunities:

    • A supportive, growth-focused team with opportunities for promotion and lateral moves internationally.

  • Rewards and Benefits:

    • A comprehensive rewards package, including high-quality healthcare, wellness programs, and gender-neutral parental leave.

  • Commitment to Diversity:

    • Sanofi fosters a diverse, inclusive workplace and is an Equal Opportunity employer.