Associate Director, Clinical Development Medical Director (MD Required)

Pfizer • San Diego, CA

1d • $189,200 - $315,400 • Hybrid

About The Position

The Associate Director, Clinical Development Medical Director is accountable for the medical and scientific integrity of one or more clinical trials and for the wellbeing of enrolled patients. The role applies technical, clinical, and medical expertise to design efficient, high-quality trials using quantitative design principles and clinical best practices, supporting clinical and operational excellence.

The position is responsible for effective study execution and works closely with clinical and medical colleagues, clinical operations, and other functional teams. It is accountable for timely delivery of quality protocols, clinical execution, and appropriate interpretation and communication of trial data. The role maintains compliance with internal and external standards, proactively mitigates risk, and manages emerging clinical and medical issues through diligent review of clinical data, safety information, and protocol deviations. It may include medical monitoring of one or more trials.

The Associate Director is the primary contact for external investigators and the internal study team on clinical and medical questions about the protocol, and partners with or supports the Global Development Lead on study and disease-area strategy. The role may also contribute to regulatory filings and responses, audits and inspections, and continuous improvement of clinical trial execution.

This is a hybrid position requiring the employee to live within commuting distance and work on-site an average of 2.5 days per week. Global travel may be required. Candidates must be authorized to work in the United States; work visa sponsorship is not available.

Requirements

• Primary medical degree from a recognized medical school or university, such as MD, DO, MBBS, or MBChB.
• Clinical research experience.
• Licensure by a licensing body or health authority to prescribe medicines independently of supervision for at least two years after the intern, house officer, or foundation period.
• Clinical research experience in Phase 3 or pivotal trials.
• Demonstrated scientific writing skills and scientific productivity through publications, posters, abstracts, and/or presentations.
• Excellent verbal and written communication skills in English.
• Clinical/medical, administrative, and project management capabilities.
• Demonstrated ability to influence and collaborate with peers, develop and coach others, and guide colleagues' work.
• Authorization to be employed in the United States by any employer and permanent U.S. work authorization; work visa sponsorship is not available.

Nice To Haves

• Maintained medical registration or license to practice and consistently remained in good standing with the medical licensing authority.
• Clinical research experience in industry or a contract research organization.
• Cardiometabolic disease experience, such as cardiology, obesity, endocrinology, or nephrology.
• Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, and adverse event management.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and productivity.
• Curiosity about how AI tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Perform medical monitoring on one or more clinical trials, providing study-related medical information and assistance on investigator and site questions, safety findings, complex serious adverse events, and medical responses to audits or inspections.
• Contribute to final medical assessments of significant quality events.
• Conduct and document periodic safety data reviews and ongoing clinical and medical data reviews with clinical colleagues.
• Review required safety text and endorse significant medical changes to Informed Consent Documents.
• Provide clinical and medical input to the protocol design document and lead or support protocol development from the approved design document.
• Develop efficient protocols that support operational efficiency, trial quality, and participant and site engagement while reducing the likelihood of amendments or quality issues; support the Global Development Lead in governance review and approval.
• Lead development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provide clinical and medical input to data collection tools, the Statistical Analysis Plan, tables/listings/figures, and the database review plan.
• Author and manage approval of Informed Consent Documents, including responses to external stakeholder questions.
• Provide clinical and medical input to the Integrated Quality Management Plan and review and approve the final document.
• Establish Data Monitoring Committees and endpoint adjudication committees, including charters, contracts, relevant data, and documentation of outcomes.
• Input to, review, and approve Risk Management and Safety Review Plans; ensure activities follow approved plans and work with stakeholders to develop and implement risk mitigations.
• Review and approve country selection, develop site selection criteria, and contribute to site training materials.
• Serve as the primary contact for external investigators and the internal study team on clinical and medical protocol questions.
• Review, report, and manage protocol deviations; review patient-level and cumulative data according to the data review plan.
• Review safety data, serious adverse event reports, treatment-emergent and drug-related medical events, and ensure clinical documents are updated as required.
• Track and reconcile serious adverse events across a study and lead presentation of data during Safety Review Team meetings.
• Ensure compliance of clinical documents in the Trial Master File.
• Input to and review the Clinical Study Report, including narratives; support disclosure of safety and efficacy data and trial conclusions; contribute to primary publication of trial results.
• Provide clinical support to study teams or programs during audits and inspections.
• Contribute, if required, to clinical sections of regulatory filings and responses, including pediatric investigation plans, Investigator Brochures, IND/NDA annual reports, periodic safety update reports, regulatory authority responses, audit or inspection findings, and Clinical Trial Applications.
• Contribute to continuous improvement, process enhancement, and innovative approaches to clinical trial execution.
• Collaborate with and influence peers, develop and coach others, and oversee and guide colleagues' work to achieve meaningful outcomes and business impact.

Benefits

• 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.
• Medical, prescription drug, dental, and vision coverage.
• Eligible to participate in Pfizer’s Global Performance Plan, with a bonus target of 22.5% of base salary.
• Eligible to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs and/or eligibility.
• Comprehensive benefits and programs intended to support colleagues’ health and life events.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree