Clinical Development Executive Medical Director

About the role

This position is for a Clinical Development Executive Medical Director within the GU Therapeutic Area, responsible for defining and executing 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 representing program(s) externally.

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
• Serve as the subject matter expert on clinical issues
• Endorse clinical development decisions in advance of GPT, senior management reviews or governance bodies
• Provide oversight and management responsibilities of medical director(s)
• Serve 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
• Lead 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)
• Provide clinical input in the preparation and execution of meetings with health authorities, including leading discussions with regulators and leading/contributing to regulatory query responses
• Support business development initiatives, as appropriate, and as such may design/conduct/review protocols as a member of a due diligence team

Basic 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

Preferred Qualifications

• 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

Additional Information

• Individual contributor or may have management responsibilities for 1-6 Associate Medical Directors, Medical Directors or Senior Medical Directors
• Reports to Therapeutic Area Head
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
• Ability to travel globally as needed
• May be required to work outside of typical working hours to accommodate other time zones and address time sensitive business needs
• Occasional travel will be required
• Relocation support available
• Work Location Assignment: Hybrid

Pay

• Annual base salary: $274,000.00 to $456,600.00
• Eligible for participation in Pfizer's Global Performance Plan with a bonus target of 30.0% of the base salary
• Eligible to participate in share based long term incentive program

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 including medical, prescription drug, dental and vision coverage