Clinical Development Medical Executive Director Responsibilities:
- May lead product specific Global Development Team (GDT)
- Serve as subject matter expert on clinical issues
- Lead, develop, and execute clinical development plan for one or more indications aligned with Lifecycle Management Plan and Integrated Product Plan
- Endorse clinical decisions with Global Development Product Lead (GDPL) and governance bodies
- May oversee and manage medical directors
- Accountable with GDPL for clinical development strategy, trial design, execution, and delivery of trial results
- Integrate regulatory, statistical, and stakeholder input into study designs
- Serve as primary interface with Development Review Committee
- Oversee development/management of clinical protocols and amendments, investigator brochures, and clinical study reports
- Oversee evaluation, interpretation, reporting, and presentation of study data
- Accountable for clinical evaluations and safety decisions; escalate to GDPL as needed
- Accountable with clinical pharmacology for optimal dose and schedule selection
- Accountable with regulatory for health authority interactions; escalate to GDPL as necessary
- May participate in evaluating business development opportunities
- Conduct medical monitoring (eligibility assessment, data review, safety monitoring)
- Lead peer-to-peer interactions with investigators
- Point of contact for clinical issues between study team, investigators, ethics/steering committees, and regulatory authorities
- Lead/contribute to clinical trial and regulatory document development with Clinical Scientist and cross-functional team
- Oversee clinical development leadership across several study teams
- Serve as Clinical Development Lead on working groups/subteams (including for Marketing Authorization Applications and business development)
Strategic Guidance & Clinical Insights:
- Lead, develop, and execute therapeutic-area strategy for one or multiple medicines with GDPL collaboration
- Represent the company in external engagements/joint collaborations
- Collaborate with Clinical Scientist to interpret data, identify key findings, and communicate to stakeholders
- Stay current with literature/guidelines to drive clinical development plans
Basic Qualifications:
- Medical degree or advanced degree with 5+ years relevant clinical/industry experience
- Licensed/registered to prescribe independently for at least 2 years
- 5+ years leading diverse teams
- Prior management responsibilities for medical directors or clinical scientists
- Late phase drug development experience
Preferred Qualifications:
- Board certified/eligible in oncology (or equivalent)
- Experience in thoracic cancer and/or immuno-oncology trials
- Experience across multiple phases and oncology drug classes
- Experience leading NDA, BLA, or MAA
Relocation support and hybrid work assignment (2.5 days/week on-site) are mentioned. Compensation includes base salary range ($295,900β$493,100) and eligibility for performance bonus and long-term incentives; comprehensive benefits including 401(k) match, paid time off, leave, and medical/dental/vision are listed.