Clinical Development Medical Executive Director (Thoracic Cancers)
Responsibilities:
- Lead product-specific Global Development Team (GDT) and serve as subject matter expert on clinical issues.
- Lead, develop, and execute clinical development plans for one or more indications in alignment with Lifecycle Management Plan/Integrated Product Plan.
- Endorse clinical decisions with Global Development Product Lead (GDPL), senior management reviews, or governance bodies.
- Provide oversight/management of medical directors (as applicable).
- Accountable for clinical development strategy, trial design, execution, and delivery of trial results with GDPL.
- Integrate regulatory, statistical, and stakeholder input into study designs.
- Primary interface with Development Review Committee.
- Oversee clinical protocols/amendments, investigator brochures, and clinical study reports.
- Oversee evaluation, interpretation, reporting, and presentation of study data.
- Accountable for safety decisions and clinical evaluations; escalate to GDPL as needed.
- Accountable with clinical pharmacology for optimal dose/schedule selection.
- Accountable with regulatory for health authority interactions (escalate to GDPL as needed).
- 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 regulators.
- Lead/contribute to development and maintenance of clinical trial and regulatory documents.
- Provide clinical development leadership across multiple study teams; serve as Clinical Development Lead on working groups/subteams incl. MAAs and business development opportunities.
- Represent the company in external engagements/joint collaborations; collaborate with Clinical Scientist to interpret clinical data and communicate findings.
Qualifications:
- Medical degree or advanced degree with 5+ years relevant clinical/industry experience.
- Licensed/registered to prescribe medicines independently for at least 2 years.
- 5+ yearsβ experience leading diverse teams.
- Prior management responsibilities of medical directors or clinical scientists.
- Late phase drug development experience.
Preferred:
- Board certified/eligible in oncology.
- Experience leading trials in thoracic cancer and/or immuno-oncology.
- Experience across multiple clinical phases and oncology drug classes.
- Experience leading NDA/BLA/MAA.
Relocation support available; hybrid work (on-site ~2.5 days/week, within commuting distance).