Associate Director, Clinical Development Medical Director (MD Required)

Job Summary

The Associate Director, Clinical Development Medical Director 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.

The role is responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines. The Associate Director is accountable for timely delivery of a quality protocol, clinical execution of clinical trials, and supports appropriate interpretation and communication of clinical trial data. 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. May perform medical monitoring of one or more clinical trials. Will be the primary contact with external investigators and 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: provides study-related medical information and assistance 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
• Contributes to final significant quality event medical assessments
• Jointly with clinical colleagues, conducts and documents periodic safety data reviews and ongoing clinical/medical data review
• 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)
• Leads or supports development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality, and participant/site engagement and which minimize the likelihood of amendments or quality issues
• 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
• Responsible for providing clinical/medical input 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 development of the Integrated Quality Management Plan (IQMP); reviews and approves final document
• Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data, and documentation of outcomes
• Inputs to, reviews, and approves Risk Management and Safety Review Plan; ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead, etc.) to develop and implement any risk mitigations
• Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials
• Serves as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol
• Reviews, reports, and manages protocol deviations
• Reviews patient level and cumulative data per the data review plan across one or more studies
• Reviews safety data, SAE reports, TMEs, DMEs 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
• Inputs and reviews the Clinical Study Report including the review of narratives
• Responsible for supporting disclosure of safety and efficacy data and trial conclusions
• Contributes to primary publication of clinical trial results
• Provides clinical support to the study team or clinical program in response to audits or inspections
• 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)
• Contributes to continuous improvement/process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution

Basic Qualifications

• Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university and has Clinical Research experience
• 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 research experience in phase 3/pivotal space
• Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations

Preferred Qualifications

• Have maintained registration/Medical License to practice and always have been in good standing with their Medical Licensing Authority preferred
• Clinical Research experience in industry/CRO
• Cardiometabolic disease experience highly preferred (i.e., cardiology, obesity, endocrinology, nephrology, etc.)
• 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, in relating to individuals both inside and outside Pfizer
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
• 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

Work Schedule, Travel, or Environment Requirements

Global travel may be required. This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.