Jobs · Analyst · Massachusetts

Senior Clinical Research Director - Oncology

BioSpace · Cambridge, MA · 2 wk ago
On-siteAnalystFull-time

About the role

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.

Main Responsibilities

  • Working within a matrix model, 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 filings, annual reports, development risk management plans.
  • Lead the clinical interpretation of study results
  • Contributes 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.

About You

  • Education: Medical Doctor (MD) or equivalent; training in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies is a plus.
  • Experience: At least 4 years experience in clinical development in the pharmaceutical industry, CRO, or healthcare institution.
  • Soft skills: Excellent communication skills (verbal and written English) with both internal and external stakeholders; adept at problem solving; thoughtful risk-taking; demonstrated ability to work with a multi-functional team to achieve project milestones; understanding of and willingness to meet applicable regulatory, quality and compliance standards; quality-focused, adept at developing good practices, open-minded to data-driven approaches and new digital solutions; international/intercultural working skills.

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