Clinical Development Medical Director, Inflammation & Immunology

Pfizer • New York City, MA

2d • Hybrid

About The Position

The Clinical Development Medical Director is accountable for the medical and scientific integrity of one or more clinical trials and the well-being of enrolled patients. The role applies clinical, medical, and technical expertise to design efficient, high-quality trials using quantitative design principles and clinical best practices, and partners closely with Clinical Operations to deliver clinical and operational excellence. The director leads clinical execution of medium- to high-complexity studies with significant business impact, ensuring timely delivery of quality protocols, appropriate data interpretation and communication, and compliance with internal and external standards. The position includes medical monitoring, diligent review of clinical data, safety information, and protocol deviations, and proactive identification and mitigation of clinical risks. The director is the primary contact for external investigators and the internal study team on clinical and medical protocol questions, and may provide matrix management support to clinicians. AI-enabled clinical development tools and digital approaches are used to support trial design, execution, data review, signal detection, and risk identification.

The role is hybrid, requiring an average of 2.5 days onsite, with candidates required to be commutable to a site. The U.S. annual base salary range is $239,900 to $399,800. The position is eligible for Pfizer’s Global Performance Plan, with a 25% bonus target, and participation in a share-based long-term incentive program. Relocation assistance may be available based on business needs and/or eligibility. Candidates must have permanent U.S. work authorization; visa sponsorship is unavailable.

Requirements

• MD or equivalent.
• At least 5 years of successful experience in biopharmaceutical industry clinical research and development.
• Demonstrated scientific productivity, such as a doctoral thesis, publications, or research reports.
• Extensive knowledge of clinical development, global and regional regulations, ICH/GCP, and adverse event management.
• Demonstrated clinical/medical, administrative, and project management capabilities.
• Effective verbal and written communication skills when working with people inside and outside Pfizer.
• Demonstrated experience managing and training large teams in clinical development.
• Must be commutable to a site for a hybrid schedule averaging 2.5 onsite days per week.
• Must have permanent U.S. work authorization; U.S. work visa sponsorship is not available.

Nice To Haves

• Postgraduate training, certification, or fellowship in Dermatology, Rheumatology, or Pulmonology.
• Postgraduate training, certification, or fellowship in drug development.
• Experience using AI-enabled tools, automation, data visualization, or digital clinical trial technologies.
• Demonstrated experience in designing and launching large teams.

Responsibilities

• Autonomously lead clinical execution of one or more medium- to high-complexity studies with significant business impact; may be accountable for program-level clinical deliverables.
• Contribute to development of the Protocol Design Document and lead development of the protocol from the approved document, aiming to maximize operational efficiency, trial quality, and participant and site engagement while minimizing amendments and quality issues.
• Provide clinical input to the DORA process and support data standards, optimized data collection, and timely, thorough data review.
• Provide clinical input to the Statistical Analysis Plan, tables, listings, and figures, and the BDR.
• Author and manage approval of Informed Consent Documents, including responses to external stakeholder questions.
• Provide clinical 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 the Risk Management and Safety Review Plan; ensure activities follow the plan and partner with stakeholders to develop and implement risk mitigations.
• Review and approve country selection, develop site selection criteria, ensure protocol-specific training, and approve investigator meeting plans.
• Serve as the primary contact for external investigators and the internal study team on clinical protocol questions.
• Review, report, and manage protocol deviations and approve protocol amendments.
• Review patient-level and cumulative data across studies according to the data review plan; review safety data, serious adverse event reports, and other safety events, and ensure clinical documents are updated as needed.
• Track and reconcile serious adverse events across a study and lead data presentations at Safety Review Team meetings.
• Act as medical monitor on one or more clinical trials.
• Ensure Trial Master File compliance for clinical documents.
• 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 clinical trial results.
• Provide clinical support to the study team or clinical program during audits and inspections.
• May contribute to clinical sections of regulatory filings and support colleagues with regulatory-query responses, audit and inspection findings, and Clinical Trial Applications.
• Contribute to continuous improvement, process enhancement, and innovative approaches to clinical trial execution.
• May provide matrix management support to clinical colleagues.
• Proactively mitigate risks and manage emerging clinical issues through timely review of clinical data, safety information, and protocol deviations.
• Use AI-enabled tools and analytics for clinical data review, signal detection, and risk identification; support innovation, user feedback, and adoption of digital clinical development tools.

Benefits

• 401(k) plan with Pfizer matching contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility for Pfizer’s Global Performance Plan with a 25% bonus target.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

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