Director, Clinical Development Medical Director (MD Required)

Job Summary

The Director, Clinical Development Medical Director (MD Required) is accountable for the medical & scientific integrity of the study and the wellbeing of the patients enrolled in one or more clinical trials. The role applies technical and clinical/medical skills to ensure the design of efficient and high‑quality clinical trials, employing quantitative design principles, and clinical best practices to deliver both clinical and operational excellence.

Job Responsibilities

• Perform medical monitoring on one or more clinical trials.
• Provide study‑related medical information and assistance, e.g., on medical questions from investigators, site personnel and non‑study health care providers, safety findings, medical issues, and complex serious adverse events audits or inspection medical responses.
• Contribute to final significant quality event medical assessments.
• Jointly with clinical colleagues, conduct and document periodic safety data reviews, and ongoing clinical/medical data review.
• Review required safety text and endorse significant medical changes in the Informed Consent Document.
• Autonomously and independently lead clinical execution of one or more studies of medium‑high complexity and significant business impact; may be accountable for program‑level clinical deliverables.
• Provide clinical/medical input to support development of the protocol design document (PDD).
• Lead development of the protocol from the approved PDD and ensure efficient protocols that maximize operational efficiency, trial quality and participant/site engagement while minimizing likelihood of amendments or quality issues; partner with the Global Development Lead in governance review and approval process.
• Lead development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provide clinical/medical input to the development of data collection tools; responsible for providing clinical/medical input to SAP, TLFs and BDR.
• Author and manage approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Provide clinical/medical input to development of the Integrated Quality Management Plan (IQMP); review and approve final document.
• Be accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Input to, review, and approve Risk Management and Safety Review Plan; ensure activities are conducted consistent with the approved plan and partner with key stakeholders (clinical operations, safety risk lead, etc.) to develop and implement any risk mitigations.
• Review and approve country selection, develop site selection criteria, and contribute to authoring and delivery of site training materials.
• Serve as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol.
• Review, report and manage protocol deviations.
• Review patient‑level and cumulative data per the data review plan across one or more studies.
• Review safety data, SAE reports, TME’s, DME’s and ensure clinical documents (e.g., ICD) are updated as required; track and reconcile serious adverse events (SAEs) across a study and lead presentation of data during Safety Review Team meetings.
• Act as the medical monitor on one or more clinical trials.
• Ensure TMF compliance for clinical documents.
• Input and review the Clinical Study Report including the review of narratives; responsible for supporting disclosure of safety and efficacy data and trial conclusions; contribute to primary publication of clinical trial results.
• Provide clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection.
• May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and Periodic Safety Update Reports and regulatory authority responses) if required.
• May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs).
• Contribute to continuous improvement/process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
• May provide matrix management support to one or more clinical colleagues.

Basic Qualifications

• Medically qualified individual; obtain a primary medical degree (MD, DO, MBBS, MBChB) from a recognized medical school/university and have a minimum of 4 years clinical development experience in industry/CRO.
• Licensed to prescribe medicines independently for at least 2 years post the intern/house officer/foundation period.
• Maintained registration/Medical License to practice in good standing with medical licensing authority.
• Clinical research experience in phase 3/pivotal space.
• Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations.
• Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
• Demonstrated clinical/medical, administrative, and project‑management capabilities, as well as excellent verbal and written communication skills in English, relating to individuals both inside and outside Pfizer.
• Demonstrated experience establishing, managing, and training teams in clinical development.

Preferred Qualifications

• Cardiometabolic disease experience highly preferred (cardiology, obesity, endocrinology, nephrology, etc.).
• Broad diverse leadership experience and capabilities, including influence, collaboration with peers, development and coaching of others, and oversight of work to achieve meaningful outcomes and business impact.

Non‑Standard Work Schedule, Travel or Environment Requirements

Global travel may be required.

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

Compensation and Benefits

The annual base salary for this position ranges from $226,300 to $377,100. In addition, the position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25% of the base salary and eligibility to participate in our share‑based long‑term incentive program. We offer comprehensive and generous benefits, including a 401(k) plan with Pfizer matching contributions, additional retirement savings contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits such as medical, prescription drug, dental and vision coverage.

Relocation assistance may be available based on business needs and/or eligibility.

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.

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