Clinical Development Executive Medical Director, Thoracic

Clinical Development Medical Executive Director (Thoracic Cancers)

Responsibilities:

• Define and execute clinical development strategy for oncology program(s) in alignment with Lifecycle Management Plan and Integrated Product Plan.
• Lead product specific Global Development Team (GDT) and/or serve as clinical lead across multiple clinical trials.
• Serve as subject matter expert on clinical issues; endorse clinical decisions with Global Development Product Lead (GDPL) and governance bodies.
• 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 and amendments, investigator brochures, and clinical study reports.
• Oversee evaluation, interpretation, reporting, and presentation of study data.
• Accountable for safety decisions and clinical evaluations; coordinate with clinical pharmacology for optimal dose/schedule selection.
• Accountable for regulatory interactions with health authorities (as needed); serve as point of contact among study team, investigators, ethics/steering committees, and regulators.
• Conduct medical monitoring (eligibility assessment, data review, safety monitoring); lead peer-to-peer interactions with investigators.
• Lead and contribute to development/maintenance of clinical and regulatory documents with Clinical Scientist and cross-functional team.
• Participate in business development opportunity evaluation; serve on working groups including for Marketing Authorization Applications.

Qualifications (Basic):

• Medical degree or advanced degree with relevant clinical/industry experience (typically 5+ years).
• Licensed/registered to prescribe medicines independently for at least 2 years.
• 5+ years leading diverse teams.
• Prior management responsibilities of medical directors or clinical scientists.
• Late phase drug development experience.

Preferred:

• Board certified/eligible in oncology (or equivalent).
• Experience in thoracic cancer and/or immuno-oncology trials.
• Experience across multiple oncology phases and drug classes.
• Experience leading NDA/BLA/MAA.

Benefits/Relocation:

• Relocation support available.

Work location:

Hybrid; commute distance; on-site ~2.5 days/week.