Clinical Development Medical Executive Director (Thoracic Cancers)
Responsibilities
- Define and execute oncology program development strategy; lead one or more subteams in clinical development and/or serve as clinical lead across multiple clinical trials.
- Serve as clinical subject matter expert; lead/develop/execute clinical development plans aligned with Lifecycle Management Plan and Integrated Product Plan.
- Endorse clinical decisions with Global Development Product Lead (GDPL) and governance.
- Accountable for clinical development strategy, trial design, execution, and delivery of trial results; integrate regulatory/statistical/stakeholder input into study designs.
- Primary interface with Development Review Committee.
- Oversee clinical protocols/amendments, investigator brochures, and clinical study reports; evaluate/interpret/report/present study data.
- Accountable for safety decisions (escalate to GDPL), optimal dose/schedule selection with clinical pharmacology, and health authority interactions with 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/contribute to trial and regulatory documents.
- Represent company externally; participate in business development evaluations.
Qualifications
- Medical or advanced degree; typically 5+ years relevant clinical/industry experience.
- Licensed/registered to prescribe independently for at least 2 years.
- 5+ years leading diverse teams; prior management responsibilities of medical directors/clinical scientists.
- Late-phase drug development experience.
Preferred
- Board certified/eligible in oncology.
- Thoracic cancer and/or immuno-oncology trial experience; multi-phase oncology experience.
- Experience leading NDA/BLA/MAA.
Relocation support; hybrid role (on-site ~2.5 days/week). Base salary: $295,900β$493,100; bonus target 30% + long-term incentives; benefits include 401(k) and healthcare/leave.