Clinical Development Executive Medical Director, Thoracic

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; elevate to GDPL as needed
• Accountable with clinical pharmacology for optimal dose and schedule selection
• Accountable with regulatory for health authority interactions; elevate 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 ($295,900–$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.