Clinical Research Director - Oncology
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Upload Your ResumeAbout This Role
Lead clinical trial strategy for multiple myeloma assets, creating synergy across multiple departments to establish and execute development plans at Sanofi, a biopharma company using AI-powered research to improve lives.
Responsibilities
- Establish or adapt clinical development and contingency plans by engaging with clinical investigators, advisors, and regulatory authorities
- Author protocols, extended synopses, clinical sections of the Investigator Brochure, IND/IMPD fillings, annual reports, development risk management plans
- Lead the clinical interpretation of study results
- Contribute to clinical study reports and clinical summaries, including regulatory submissions
- Provide expert medical guidance to other functions, including Clinical Operations, Biostatistics, and Translational Medicine, to ensure optimal planning and execution of clinical trials
- Present and discuss development strategy and clinical study results with key internal stakeholders, external investigators, advisory boards, and regulatory authorities
- Author clinical abstracts, presentations for conferences, and manuscripts
Requirements
- Medical Doctor (MD) or equivalent
- Training in Oncology and/or Hematology
- 4+ years experience in clinical development in the pharmaceutical industry, CRO, or healthcare institution
- Excellent communication skills (verbal and written English)
- Adept at problem solving
- Understanding of and willingness to meet applicable regulatory, quality and compliance standards
Qualifications
- Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology
- At least 4 years experience in clinical development in the pharmaceutical industry, CRO, or healthcare institution
Nice to Have
- Experience in myeloma or hematologic malignancies
- Thoughtful risk-taking: challenge decisions and status quo with a risk-management approach
- Demonstrated ability to work with a multi-functional team to achieve project milestones
- Quality-focused, adept at developing good practices, open-minded to data-driven approaches and new digital solutions
- International/ intercultural working skills
Skills
* Required skills
Benefits
About Sanofi
Sanofi is a leading investor in life sciences, manufacturing and research and development, focusing on addressing unmet medical needs and improving people's lives through science.