Associate Director, Clinical Development Medical Director (MD Required)
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Job Summary
* Accountable for the medical & scientific integrity of the study and the wellbeing of the patients enrolled in one or more clinical trials.
* 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.
* Responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines.
* Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical/medical issues through timely, diligent clinical data, safety and protocol deviation review.
* Primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol and partners with/supports the Global Development Lead regarding study and disease area strategy.
Job Responsibilities
* Performs medical monitoring on one or more clinical trials:
o Provides study‑related medical information and assistance on medical questions from investigators, site personnel and non‑study health care providers.
o Deals with safety findings, medical issues, and complex serious adverse events.
o Responds to audits or inspections with medical responses.
o Contributes to final significant quality event medical assessments.
o Conducts and documents periodic safety data reviews and ongoing clinical/medical data review with clinical colleagues.
* Reviews required safety text and endorses significant medical changes in the Informed Consent Document.
* Provides clinical/medical input to support development of the protocol design document (PDD) and ensures efficient protocols that maximize operational efficiency, trial quality and participant/site engagement while minimizing amendments or quality issues.
* Leads or supports development of the protocol from the approved PDD and partners with/supports the Global Development Lead in governance review and approval process.
* Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
* Provides clinical/medical input to the development of data collection tools and to SAP, TLFs, and BDR.
* Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
* Provides clinical/medical input to the development of the Integrated Quality Management Plan (IQMP) and reviews and approves the final document.
* Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
* Reviews, reports and manages protocol deviations.
* Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
* Reviews patient level and cumulative data per the data review plan across one or more studies.
* Reviews safety data, SAE reports, TME’s, DME’s and ensures clinical documents (e.g., ICD) are updated as required.
* Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
* May act as the medical monitor for one or more clinical trials.
* Ensures TMF compliance for clinical documents.
* Reviews and reports the Clinical Study Report, including narratives, and supports disclosure of safety and efficacy data and trial conclusions.
* Provides clinical support to the study team or clinical program in response to audits or inspections, including support as needed.
* May contribute to clinical sections of regulatory filings such as Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, and Periodic Safety Update Reports.
* May support responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs).
* Contributes to continuous improvement and process enhancement activities.
Basic Qualifications
* Medically qualified individual with a primary medical degree (MD, DO, MBBS, MBChB) from a recognized medical school/university.
* Clinical research experience in phase 3/pivotal space.
* Licensed to prescribe medicines independently for at least two years post‑internship/house officer/foundation period.
* Maintained registration/medical license in good standing with the medical licensing authority.
* Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations.
Preferred Qualifications
* Clinical research experience in industry or CRO.
* Cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.) highly preferred.
* Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, and adverse event management.
* Demonstrated clinical/medical, administrative, and project management capabilities with excellent verbal and written communication skills in English.
Candidate Profile
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 colleagues to achieve meaningful outcomes and create 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
The annual base salary ranges from $182,000.00 to $303,300.00, plus eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary and participation in a share‑based long‑term incentive program.
Benefits
Benefits include a 401(k) plan with Pfizer matching contributions and an additional retail contribution; paid vacation, holiday and personal days; paid caregiver/parental and medical leave; and health benefits covering medical, prescription drug, dental and vision coverage.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws. If you are a licensed physician who incurs recruiting expenses that Pfizer reimburses, your name, address and the amount of payments may be reported to the government.
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, work authorization, and employment eligibility verification requirements. This position requires permanent work authorization in the United States.
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