Senior Medical Director

3 weeks ago


Massachusetts, United States Pharma People Full time

Our innovative Oncology ADC Pre-IPO biotech client is seeking a Medical Director / Senior Medical Director with strong Oncology Clinical Development experience to cover development programs spanning phases I, II, III.

Responsibilities:

  • Providing clinical leadership; from early-stage clinical trial design for novel cancer drugs through to CoP stage
  • Work closely and liaise with the clinical operations team, clinical study teams, pharmacovigilance, the VP and stakeholders
  • Involvement in protocol design through all phases
  • Support regulatory leaders with submissions and strategy development.
  • Prepare clinical reports and publications
  • Presentations at regulatory meetings, internal and external meetings

Requirements & Qualifications:

  • An M.D. or M.D/Ph.D. with 6+ years’ experience as a Medical Director in Oncology Clinical Development
  • Significant drug development experience from IND through NDA
  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in strategy development and protocol design
  • Ability to work well with others and build up members of a cross-functional team in a fast-paced start-up environment.

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