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Senior Clinical Research Director - Bone Marrow Transplantation

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

Senior Clinical Research Director - Bone Marrow Transplantation
Location: Cambridge, MA
Employment: Permanent
Salary Range: USD 225,000 - 325,000
Posted on: Apr. 05, 2025
Closing on: Jun. 06, 2025
Company: Sanofi

Job Summary:
The Senior Clinical Research Director for Bone Marrow Transplantation will lead the execution of clinical development strategies for assigned Phase 2 and Phase 3 programs. This role will include overseeing clinical trials, evaluating business development opportunities, and providing clinical leadership in the stem cell transplant program. The Director will work cross-functionally to ensure optimal planning and execution of clinical programs.

Main Responsibilities:

  • Leadership & Supervision:

    • Supervise Clinical Research Directors and Clinical Scientists of ongoing clinical trials.

    • Lead clinical interpretation of study results and generate clinical study reports and regulatory submissions.

  • Collaboration & Strategy Development:

    • Work with cross-functional teams (Clinical Operations, Medical, Biostatistics, Regulatory, etc.) to ensure efficient execution of clinical programs.

    • Establish clinical development strategies for the program and engage with clinical investigators, advisors, and regulatory authorities.

  • Clinical Development & Documentation:

    • Lead the authoring of key clinical documents including protocol synopses, Investigator Brochures, IND/IMPD filings, and development risk management plans.

    • Lead responses to clinical questions from health authorities and present clinical program plans or results to regulatory bodies.

  • Clinical Guidance & Support:

    • Provide clinical guidance to various functions including Clinical Operations, Biostatistics, and Translational Medicine.

    • Assist in authoring clinical abstracts, presentations for conferences, and manuscripts when appropriate.

  • Business Development & Stakeholder Engagement:

    • Evaluate business development opportunities within stem cell transplant programs.

    • Present clinical development strategy results to internal stakeholders and governance bodies.

Minimum Qualifications:

  • Education:

    • Medical degree required.

    • Oncology and/or Hematology fellowship training or significant clinical experience (6+ years) in Oncology/Hematology.

  • Experience:

    • At least 5 years of clinical practice in bone marrow transplantation.

    • Minimum of 5 years in translational or clinical trials as an investigator in academia or as a study lead in industry.

  • Skills & Abilities:

    • Ability to work independently and in teams to execute clinical development plans.

    • Strong communication skills to interact with internal and external stakeholders.

    • Proficiency in speaking and writing in English.

Why Choose Us?

  • Growth Opportunities:

    • A dynamic and supportive team offering career advancement opportunities, 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.