Clinical Development Executive Medical Director

Pfizer • Bothell, WA

3d • Hybrid

About The Position

This position is for a Clinical Development Executive Medical Director within the GU Therapeutic Area. The Clinical Development Executive Medical Director will be responsible for defining and executing on the development strategy of Enfortumab vedotin. Reporting to the Vice President, GDPL, Bladder Cancer, the successful candidate should have demonstrated proficiency in leading and/or supporting development programs, cross-functional collaboration, and represent program(s) externally.

Requirements

• 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
• Candidates must be authorized to be employed in the United States.

Nice To Haves

• 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

• 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.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation support available

What This Job Offers

• Job Type: Full-time
• Career Level: Senior