Senior Medical Director
3 weeks ago
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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