Clinical Development Medical Director, (MD Required)

Pfizer • San Diego, CA

1d • $239,900 - $399,800 • Hybrid

About The Position

The Clinical Development Medical Director is responsible for medical and scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies. The Director may independently lead clinical execution of studies, be accountable for program-level deliverables, and manage, supervise, mentor, or develop other clinical colleagues or contingent workers.

The role provides medical monitoring and clinical guidance throughout trial design, start-up, conduct, close-out, and reporting. It includes oversight of clinical and safety data, protocols and informed consent documents, risk management, external monitoring and adjudication committees, site training and investigator communications, regulatory and clinical study documentation, and support for audits, inspections, disclosures, and publications. The position partners with study teams and stakeholders to ensure trial quality, data integrity, compliance, and delivery of milestones.

This is a hybrid role requiring residence within commuting distance and on-site work an average of 2.5 days per week. Global travel may be required. The annual base salary range is $239,900 to $399,800, with eligibility for a performance-plan bonus targeted at 25% of base salary and a share-based long-term incentive program. Benefits include retirement contributions, paid time off and leave, and health coverage. Relocation assistance may be available based on business needs and eligibility. Candidates must have permanent U.S. work authorization; visa sponsorship is not available.

Requirements

• Primary medical degree (e.g., MD, DO, MBBS, or MBChB) from a recognized medical school or university.
• At least 4 years of biopharmaceutical-industry experience in clinical research and development.
• Licensed by a licensing body or Health Authority to prescribe medicines independently of supervision for at least 2 years after the intern, house officer, or foundation period.

Nice To Haves

• Experience in cardiometabolic diseases, such as obesity, diabetes, or endocrinology.
• Maintained medical registration or license to practice and remained in good standing with the Medical Licensing Authority.
• Biopharmaceutical clinical research experience in study design, start-up, conduct, and close-out, including regulatory submissions and inspections.
• Scientific productivity demonstrated through publications, posters, abstracts, or presentations.
• Extensive knowledge of clinical development, global and regional regulations, and ICH/GCP.
• Clinical, administrative, and project management capabilities, with effective verbal and written communication skills.
• Experience launching, managing, and training clinical development teams.
• Track record of achievement in pharmaceutical development and ability to coordinate and execute clinical development across design, start-up, conduct, close-out, and reporting.
• Understanding of complexities and recent developments in principal disease areas, and competence discussing scientific and regulatory aspects of drug development.
• Ability to prioritize and manage cross-functional teams and complex projects to deliver milestones according to budgets and priorities, and to define and manage resource requirements.
• Effective leadership skills, including mentoring, coaching, delegating, overseeing others, developing their skills, and supporting their autonomy.
• Ability to resolve conflicts equitably, foster open dialogue, negotiate agreements, and escalate issues when appropriate.
• Ability to build team morale and belonging, share successes, and define success in terms of the whole team.
• Personal accountability for delivery of results.
• Ability to demonstrate perspective and poise amid uncertainty and organizational change.

Responsibilities

• Provide medical monitoring and timely study-related medical information and guidance to investigator sites and study teams, including on clinical trial data, medical issues, and audit or inspection findings.
• Contribute to medical assessments of Quality Events and conduct and document periodic safety data reviews and ongoing clinical and medical data reviews.
• Review required safety text and significant medical changes in Informed Consent Documents.
• Independently lead clinical execution of one or more studies and, where applicable, be accountable for program-level clinical deliverables.
• Provide input to protocol design and lead development of protocols, amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Represent study teams in internal protocol review governance submissions and interactions; partner with or support Global Development Leads on study and disease-area strategy; participate in protocol-related KOL and Health Authority interactions as applicable.
• Ensure development of Study Informed Consent Documents and responses to external stakeholder requests, including those from Health Authorities and Independent Ethics Committees.
• Provide clinical guidance on Statistical Analysis Plans and Tables, Listings, and Figures.
• Guide clinical data collection strategy, instruments, and data review plans; set the clinical data review strategy; lead review of emerging data and trends; review and query data; present data; support resolution of data issues; and ensure clinical queries are addressed for database lock.
• Provide clinical guidance on Safety Review Plans and Safety Narrative Plans; review safety data and update clinical documents as the safety profile emerges; track and reconcile Serious Adverse Events; lead clinical safety discussions in Safety Review Team meetings in collaboration with medically qualified individuals; and review safety narratives.
• Provide clinical guidance on Risk Management Plans, ensure clinical activities follow approved plans, and partner with stakeholders to develop and implement risk mitigations.
• Establish and manage External Data Monitoring Committees and Adjudication Committees, including chartering, contracting, data provision and presentation, and documentation and dissemination of recommendations.
• Develop site selection criteria, provide clinical input to site selection, and ensure protocol training is delivered to site-facing colleagues.
• Participate in investigator meeting planning and develop and deliver protocol training, including ongoing training in response to amendments, emerging data issues, and quality events.
• Serve as the primary clinical point of contact for investigators and study teams on clinical aspects of protocols; manage development, delivery, documentation, and curation of clinical responses.
• Establish protocol deviation sub-categories; ensure deviations found during clinical data review are reported and managed, and lead protocol deviation trend reviews.
• Ensure TMF compliance for clinical documents.
• Provide clinical input to and review Clinical Study Reports.
• Ensure disclosure of safety and efficacy data and trial conclusions; contribute to publications as applicable.
• Provide clinical support for audits and inspections, including responding to and addressing findings.
• Contribute clinical sections to regulatory filings as applicable, including briefing documents, Pediatric Investigational Plans, Investigator Brochures, IND/NDA Annual Reports, Periodic Safety Update Reports, and responses to Health Authority requests.
• Contribute to continuous improvement, process enhancement, and innovative approaches to improve clinical trial execution.
• Where applicable, manage, supervise, mentor, or develop clinical colleagues or contingent workers.

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
• Participation in Pfizer’s Global Performance Plan, with a bonus target of 25% of base salary
• Eligibility to participate in a share-based long-term incentive program
• Relocation assistance may be available based on business needs and eligibility

What This Job Offers

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