Clinical Development Medical Director, (MD Required)

Pfizer • San Diego, PA

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 also manage, supervise, and mentor other clinical colleagues or contingent workers.

The role may independently lead clinical execution of one or more studies and may be accountable for program-level clinical deliverables. It provides medical monitoring, clinical guidance, and oversight across study design, conduct, safety review, data review, risk management, and reporting. The Director works with internal teams, investigators, sites, external committees, Health Authorities, and other stakeholders to support high-quality clinical trial execution.

This is a hybrid role 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. The position is based in the United States and requires permanent U.S. work authorization; visa sponsorship is not available. The annual base salary range is $239,900 to $399,800, with eligibility for a performance bonus targeted at 25% of base salary and a share-based long-term incentive program. Relocation assistance may be available based on business needs and eligibility.

Requirements

• Primary medical degree from a recognized medical school or university, such as MD, DO, MBBS, or MBChB.
• At least 4 years of experience in the biopharmaceutical industry 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.
• Permanent work authorization in the United States; U.S. work visa sponsorship is not available.
• Clinical, administrative, and project management capabilities, with effective verbal and written communication skills.
• Ability to coordinate and execute clinical development through design, start-up, conduct, close-out, and reporting, delivering milestones within budgets and priorities.
• Ability to set priorities, manage cross-functional teams and complex projects, and define and manage resource requirements.
• Effective leadership skills, including mentoring and coaching, delegation, oversight, and developing others toward autonomy.
• Ability to resolve conflicts equitably, foster open dialogue, negotiate agreements, and escalate issues appropriately.
• Ability to take personal responsibility for results and demonstrate perspective and poise amid uncertainty and organizational change.

Nice To Haves

• Experience in cardiometabolic disease, 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.
• Experience launching, managing, and training clinical development teams.
• Track record of achievement in pharmaceutical development.
• Understanding of the complexities and recent developments in principal disease areas, and ability to discuss scientific and regulatory aspects of drug development competently.
• Ability to share team success, build morale and belonging, and define success in terms of the whole team.

Responsibilities

• Provide medical monitoring for one or more clinical trials, including timely medical information and guidance to investigator sites and study teams.
• Address medical issues in clinical trial data and findings from audits or inspections, and contribute to medical assessments of Quality Events.
• Conduct and document periodic safety data review and ongoing clinical and medical data review.
• Review required safety text and significant medical changes in Informed Consent Documents.
• Lead clinical execution of studies and, where applicable, be accountable for program-level clinical deliverables.
• Contribute to protocol design and lead development of protocols, amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Represent the study team in internal protocol review governance submissions and interactions; support the Global Development Lead on study and disease-area strategy; and participate in protocol-related KOL and Health Authority interactions as needed.
• Ensure development of Study Informed Consent Documents and responses to requests from external stakeholders, including Health Authorities and Independent Ethics Committees.
• Provide clinical guidance for the Statistical Analysis Plan and Tables, Listings, and Figures.
• Guide development of clinical data collection strategies, instruments, and data review plans; lead clinical data review strategy and review emerging data and trends.
• Review and query clinical data, present data to stakeholders, support site-facing colleagues in resolving data issues, and ensure clinical queries are addressed for database lock.
• Guide development of 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 at Safety Review Team meetings with medically qualified colleagues, and review safety narratives.
• Provide clinical guidance for Risk Management Plans, ensure clinical activities align with approved plans, and work with stakeholders to develop and implement risk mitigations.
• Establish and manage External Data Monitoring Committees and Adjudication Committees, including charters, 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 the study team on clinical aspects of the protocol; manage clinical response development, delivery, documentation, and curation.
• Establish protocol deviation sub-categories; ensure deviations found during clinical data review are reported and appropriately managed and reconciled; and lead deviation trend reviews.
• Ensure TMF compliance for clinical documents.
• Provide clinical input to and review the Clinical Study Report.
• Ensure disclosure of safety and efficacy data and trial conclusions, and contribute to publications as appropriate.
• Provide clinical support for audits and inspections, including responding to and addressing findings.
• Contribute to clinical sections of regulatory filings, such as 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 clinical trial execution.
• Manage, supervise, mentor, or develop clinical colleagues or contingent workers as applicable.

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
• Performance bonus opportunity with a 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