Clinical Development Executive Medical Director, Thoracic

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).