Global Oncology Clinical Development Director

Biopharma Careers; Bothell (WA); Hybrid; USD 274,000 - 457,000; Full time

Benefits offered by this job

401(k) with Pfizer matching

Health benefits

Job summary

Pfizer is seeking a Clinical Development Executive Medical Director in the United States to define and execute development strategies for Enfortumab vedotin in oncology. The role reports to the VP and leads cross-functional teams across discovery, development, and regulatory interfaces.

The candidate should have extensive experience leading multi-phase oncology programs, regulatory interactions, and managing medical directors, with global travel as needed.

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

Responsibilities

• Work across the organization and on the cross-functional Global Development Team to 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.

Skills

Leadership

Cross-functional collaboration

Clinical development

Regulatory input

Education

Medical degree or advanced degree

7+ years industry experience

5+ years leading diverse teams

Job description

Pfizer is seeking a Clinical Development Executive Medical Director in the United States to define and execute development strategies for Enfortumab vedotin in oncology. The role reports to the VP and leads cross-functional teams across discovery, development, and regulatory interfaces.

The candidate should have extensive experience leading multi-phase oncology programs, regulatory interactions, and managing medical directors, with global travel as needed.