ROLE SUMMARY
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.
ROLE 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.
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
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- 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.
OTHER 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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel will be required.
Relocation support available
Work Location Assignment:Hybrid
The annual base salary for this position ranges from $274,000.00 to $456,600.00. In addition, this position is eligible for participation in Pfizer27s Global Performance Plan with a bonus target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life27s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site 2D U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Medical
