GU Oncology: Clinical Development Executive & Medical Director

Pfizer; Cambridge (MA); Hybrid; USD 274,000 - 457,000; Full time

Job summary

Pfizer is seeking a Clinical Development Executive Medical Director in the GU Therapeutic Area to shape and execute development strategy for Enfortumab vedotin. You will lead cross-functional teams, drive trial design, and deliver study results while interfacing with regulators and health authorities.

The role demands a medical or advanced degree with substantial industry experience, demonstrated leadership, and ability to travel globally; hybrid work arrangement offered with comprehensive

Qualifications

• Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
• 7+ years industry experience.
• 5+ years of experience leading diverse teams.
• Prior management responsibilities of medical directors or clinical scientists.
• Board certified/eligible in oncology or equivalent.
• Experience across multiple phases of clinical development and across drug classes in oncology.
• Experience in leading NDA, BLA or MAA.

Responsibilities

• Lead, develop and execute the clinical development plan of Enfortumab vedotin in alignment with the Lifecycle Management Plan and Integrated Product Plan.
• Accountable for the clinical development strategy, trial design, execution, and delivery of trial results.
• Accountable for integrating regulatory, statistical and other internal and external stakeholder input into study designs.
• Lead product specific Global Development Team.
• Serves as the subject matter expert on clinical issues.
• Endorses clinical development decisions in advance of GPT, senior management reviews or governance bodies.
• Provide oversight and management responsibilities of medical director(s).
• Serves as primary interface with Development Review Committee.
• Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports.
• Oversee the evaluation, interpretation, reporting, presentation and publication of study data.
• Accountable with safety for clinical evaluations and safety decisions.
• Accountable with clinical pharmacology for defining and identifying optimal dose and schedule selection.
• Leads the preparations of the clinical content of regulatory submissions/documents (e.g., NDA, MAA, IND, sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert).
• Provides clinical input in the preparation and execution of meetings with health authorities, including leading discussions with regulators and leading/contributing to regulatory query responses.
• Supports business development initiatives, as appropriate, and as such may design/conduct/review protocols as a member of a due diligence team.

Education

Medical degree or advanced degree

Job description

Pfizer is seeking a Clinical Development Executive Medical Director in the GU Therapeutic Area to shape and execute development strategy for Enfortumab vedotin. You will lead cross-functional teams, drive trial design, and deliver study results while interfacing with regulators and health authorities.

The role demands a medical or advanced degree with substantial industry experience, demonstrated leadership, and ability to travel globally; hybrid work arrangement offered with comprehensive