Clinical Development Medical Director, GU

Job Summary

The Clinical Development Medical Director will provide medical and scientific leadership for a Phase 3 oncology clinical trial within prostate cancer.

The Clinical Development Medical Director will work in close partnership with the Clinical Scientist and cross-functional study team to oversee study conduct medical monitoring safety evaluation data interpretation and delivery of high-quality clinical and regulatory documents. The individual will also contribute to broader clinical development planning and ensure that study-level decisions remain aligned with the overall program strategy.

The role requires strong clinical judgment scientific rigor and the ability to lead through influence across a global matrix organization. The Medical Director will engage with investigators external experts health authorities internal governance bodies and colleagues across Clinical Operations Safety Regulatory Affairs Biostatistics Clinical Pharmacology Medical Writing and other partner functions.

Key Responsibilities

Study-Level Clinical Development Leadership

• Provide medical and scientific leadership for a Phase 3 oncology clinical trial within prostate cancer
• Partner with the Clinical Scientist and Clinical Study Team Lead to support effective study execution and delivery.

• Ensure that study conduct and clinical decisions are scientifically rigorous clinically appropriate and aligned with the clinical development plan.
• Provide medical input into study strategy protocol implementation operational decisions and risk-mitigation plans.
• Identify emerging clinical or scientific issues and bring forward clear evidence-based recommendations.
• Represent Clinical Development in study-team and cross-functional discussions.

• Escalate material clinical safety quality or operational risks to program leadership and appropriate governance bodies

Medical Monitoring and Patient Safety

• Serve as the Medical Monitor for the assigned clinical trial.
• Conduct medical monitoring activities including eligibility consultation medical review of participant data protocol deviation assessment and ongoing safety surveillance.
• Provide timely medical guidance to investigators study teams and clinical operations colleagues.
• Review and interpret adverse events laboratory abnormalities dose modifications treatment interruptions and other clinically significant findings.
• Partner with Safety to evaluate emerging safety signals and support benefit-risk assessments.
• Contribute to the development and implementation of appropriate safety-monitoring and risk-mitigation measures.
• Support aggregate safety reviews safety governance discussions and interactions with independent data-monitoring committees as applicable.

Clinical Data Review and Interpretation

• Collaborate with the Clinical Scientist Biostatistics Programming Safety and other team members to establish and execute clinical data-review plans.
• Review and interpret efficacy safety patient-reported outcome imaging and other relevant clinical data.
• Identify clinically meaningful trends data-quality issues inconsistencies and areas requiring further analysis.
• Provide medical interpretation of study results and communicate their implications to cross-functional stakeholders.
• Contribute to data-cut planning interim analyses database-lock readiness and final study analyses.
• Support scientifically and regulatorily defensible interpretation of primary secondary and exploratory endpoints.

Clinical and Regulatory Documents

• Lead or contribute to the development review and maintenance of:
  • Clinical study protocols and amendments
  • Investigators Brochures
  • Informed-consent documents
  • Medical-monitoring plans
  • Clinical Study Reports
  • Integrated clinical and safety summaries
  • Regulatory briefing documents
  • Health-authority questions and responses
  • Risk-management and safety-communication materials
  • Publications and scientific presentations
• Ensure that clinical interpretations and conclusions are accurate balanced internally consistent and supported by available evidence.
• Collaborate closely with Medical Writing Regulatory Affairs Safety Biostatistics and other functions to deliver high-quality documents according to program timelines.

Regulatory and Governance Support

• Provide clinical and medical input into global regulatory strategy for the assigned study.
• Support preparation for and participation in health-authority interactions.
• Present study status emerging data clinical risks and recommendations to internal governance bodies as appropriate.
• Clearly communicate areas of uncertainty and provide balanced recommendations for decision-making.
• Support inspection readiness and provide clinical rationale and documentation for key study decisions.
• Ensure that important decisions and deviations from planned approaches are appropriately documented.

Investigator and External Engagement

• Lead peer-to-peer medical interactions with investigators.
• Serve as a point of contact for clinical questions involving the study team investigators steering committees ethics committees and regulatory authorities.
• Participate in investigator meetings advisory boards scientific congresses and other external engagements.
• Develop trusted relationships with investigators and external experts while maintaining appropriate scientific and compliance standards.
• Maintain current knowledge of prostate cancer treatment clinical practice relevant literature evolving standards of care and the competitive development landscape.

Cross-Functional Collaboration

• Work closely with:
  • Clinical Scientists
  • Clinical Operations
  • Biostatistics and Programming
  • Pharmacovigilance and Safety
  • Regulatory Affairs
  • Clinical Pharmacology
  • Translational Oncology
  • Medical Writing
  • Data Management
  • Health Technology Assessment and Evidence colleagues
  • Medical Affairs
• Build alignment across functions while maintaining an independent medical and scientific perspective.
• Contribute constructively to program-level discussions planning activities and risk assessments.
• Promote consistent clinical approaches across studies when scientifically and operationally appropriate.
• Support and mentor Clinical Scientists and other study-team colleagues.

Basic Qualifications

As medically qualified individual the successful candidate must have the following qualifications:

• • Obtained a primary medical degree (e.g. MD DO MBBS MBChB) from a recognized medical school/university and has 4yearsofexperience.
  • Been licensed by a licensing body/health authority to prescribe medicines independent of Supervision for at least 2 years post their intern/house officer/foundation period.
• Clinical training and meaningful patient-care experience in oncology.
• Clinical research or drug-development experience in the pharmaceutical industry biotechnology industry academia or a comparable environment.
• Working knowledge of clinical trial design conduct analysis and interpretation.
• Understanding of Good Clinical Practice and applicable ethical and regulatory requirements.
• Ability to interpret complex clinical and safety data and translate findings into clear medical recommendations.
• Strong written and verbal communication skills.
• Demonstrated ability to collaborate and influence in a cross-functional matrix environment.

Preferred Qualifications

• 2 years experience in industry.
• Board eligibility or board certification in Medical Oncology Hematology/Oncology Urology or another relevant specialty preferred
• Prostate cancer clinical or drug-development experience.
• Experience supporting Phase 3 or registration-enabling oncology trials.
• Prior experience serving as a study Medical Monitor.
• Experience evaluating oncology efficacy endpoints and imaging-based assessments.
• Experience working with blinded independent central review and radiographic progression-free survival endpoints.
• Experience supporting regulatory submissions or health-authority interactions.
• Experience contributing to Clinical Study Reports integrated summaries Investigators Brochures protocols and regulatory responses.
• Experience with independent data-monitoring committees or other safety-governance bodies.
• Familiarity with global oncology trial execution and interactions with investigators across multiple regions.
• Ability to present complex clinical issues and recommendations to senior governance audiences.

Work Location Assignment: Thisis a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

Relocation assistance may be available

The annual base salary for this position ranges from $239900.00 to $399800.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 25.0% 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 lifes 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 (). 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.

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 providers 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 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 . 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 .

Medical

Required Experience:

Director