Clinical Development Executive Medical Director

Pfizer; Northern (KY); Hybrid; USD 274,000 - 457,000; Full time

Job summary

Pfizer is seeking a Clinical Development Executive Medical Director for the GU Therapeutic Area. The role defines and drives the development strategy for Enfortumab vedotin, reporting to the VP, GDPL, Bladder Cancer.

You will lead cross-functional teams, shape trial designs, and represent programs externally. The ideal candidate holds a medical or advanced degree with several years of industry leadership in oncology, and has experience in regulatory strategy, trial execution, and global

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
• Board certified/eligible in oncology (preferred)
• Experience across multiple phases of clinical development and NDA/MAA submissions (preferred)

Responsibilities

• Lead, develop and execute the clinical development plan of Enfortumab vedotin.
• Accountable for clinical development strategy, trial design, execution and results.
• Integrate regulatory, statistical and stakeholder input into study designs.
• Lead Global Development Team and serve as SME on clinical issues.
• Oversee clinical protocols, amendments, and regulatory documents.
• Contribute to regulatory submissions and health authority interactions.
• Provide oversight of medical directors and support governance bodies.
• Support business development activities as needed.

Skills

Leadership

Cross-functional collaboration

Clinical development

Regulatory understanding

Education

Medical degree or advanced degree

Job description

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

COMPENSATION

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 Pfizer’s 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 life’s 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 – U.S. Benefits | (uscandidates.mypfizerbenefits.com).

LOCATION

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.

EMPLOYMENT AND VISA

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.

SUNSHINE ACT

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.

Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.

If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

FRÉQUENCE DE LANGUE

Medical De carrières van Pfizer zijn uniek. In onze cultuur van individuele eigenaarschap geloven we in ons vermogen om de toekomst van de gezondheidszorg te verbeteren en in ons potentieel om miljoenen levens te transformeren. We zijn op zoek naar nieuw talent om lid te worden van onze wereldwijde gemeenschap, om nieuwe innovatieve therapieën te ontrafelen die van de wereld een gezondere plek maken.