Clinical Development Medical Executive Director (Thoracic Cancers)
Responsibilities:
- Define and execute clinical development strategy for one or more oncology program(s) in collaboration with Global Development Product Lead (GDPL).
- Lead product-specific Global Development Team(s) (GDT) and/or serve as clinical lead across multiple clinical trials and subteams.
- Serve as clinical subject matter expert; endorse clinical decisions to GPT/GDPL and governance bodies.
- Accountable for clinical development strategy, trial design, execution, and delivery of results with GDPL.
- Integrate regulatory, statistical, and stakeholder input into study designs.
- Primary interface with Development Review Committee.
- Oversee protocols/amendments, investigator brochures, and clinical study reports; lead evaluation/interpretation/reporting/presentation of study data.
- Accountable for safety decisions and escalation to GDPL as needed.
- Accountable for optimal dose/schedule selection (clinical pharmacology) and health authority interactions (regulatory).
- Conduct medical monitoring (eligibility assessment, data review, safety monitoring); lead peer-to-peer interactions with investigators.
- Serve as point of contact between study team, investigators, ethics/steering committees, and regulatory authorities.
- Lead and maintain clinical trial and regulatory documents with Clinical Scientist and cross-functional team.
- Provide clinical development leadership across multiple study teams; serve on working groups/subteams (including for Marketing Authorization Applications) and support business development opportunities.
Qualifications:
Required (Basic):
- Medical degree or advanced degree with 5+ years relevant clinical/industry experience.
- Licensed/registered to prescribe independently for 2+ years.
- 5+ years leading diverse teams.
- Prior management responsibility for medical directors or clinical scientists.
- Late-phase drug development experience.
Preferred:
- Board certified/eligible in oncology (or equivalent).
- Thoracic cancer and/or immuno-oncology trial experience.
- Experience across multiple phases and oncology drug classes.
- Experience leading NDA/BLA/MAA.
Relocation/work: Relocation support available; hybrid (live within commuting distance; average 2.5 days/week on-site).