Clinical Development Medical Senior Director
Locations:
United States – Pennsylvania, Collegeville
United States – Massachusetts, Cambridge
United States – Connecticut, Groton
United States – New York, New York City
Denmark – Ballerup
Employment Type: Full-Time
Posted: 2 Days Ago
Job Requisition ID: 4951415
Role Summary:
Pfizer is seeking a Clinical Development Medical Senior Director to lead innovative clinical development strategies, provide expert guidance on complex medical challenges, and ensure the highest scientific and ethical standards in clinical trials. This role oversees protocol design, clinical execution, risk management, and stakeholder engagement across global programs, influencing senior leaders and guiding cross-functional teams at category or portfolio levels.
Key Responsibilities:
Leadership & Strategy
Independently lead clinical execution of high-complexity studies with significant business impact.
Develop innovative approaches to clinical development and implement solutions for complex medical challenges.
Chair or lead cross-functional teams, governance, or advisory committees.
Provide matrix management to clinical colleagues and cross-functional teams.
Protocol & Content Development
Provide clinical/medical input to the protocol design document (PDD) and lead efficient protocol development to optimize operational efficiency, trial quality, and participant engagement.
Lead development of protocol amendments, administrative change letters, and Dear Investigator Letters.
Author and manage approval of Informed Consent Documents (ICDs) and respond to external stakeholder inquiries.
Clinical & Safety Oversight
Perform medical monitoring and provide clinical guidance on safety findings, serious adverse events (SAEs), audits, inspections, and investigator inquiries.
Provide clinical input for statistical analysis plans (SAP), tables, listings, figures (TLFs), and study data review.
Establish and manage Data Monitoring Committees (DMCs) and endpoint adjudication committees.
Review and approve risk management and safety review plans, ensuring adherence and implementation of mitigation strategies.
Contribute to site selection, training material development, and overall clinical program support.
Clinical Reporting & Regulatory Support
Contribute to clinical sections of regulatory filings, including Pediatric Investigational Plans, Investigator Brochures, IND/NDA annual reports, and Periodic Safety Update Reports.
Support responses to regulatory queries and Clinical Trial Applications (CTAs).
Review Clinical Study Reports and support disclosure of safety and efficacy data for publications and regulatory submissions.
Required Qualifications
Medical degree (MD, DO, MBBS, MBChB) from a recognized institution.
Minimum 7+ years of clinical research experience in the biopharmaceutical industry, including Phase 3/pivotal trials.
Licensed to prescribe medicines independently and in good standing with the relevant Medical Licensing Authority.
Extensive knowledge of clinical development, global and regional regulations, ICH/GCP, and adverse event management.
Strong project management, leadership, and team development skills.
Proven scientific writing skills with publications, posters, abstracts, or presentations.
Preferred Qualifications
Expertise in cardiometabolic diseases (cardiology, obesity, endocrinology, nephrology).
Demonstrated ability to influence peers, mentor colleagues, and guide cross-functional teams.
Strong analytical, problem-solving, and data interpretation skills for large clinical datasets.
Effective communication, presentation, and organizational skills in global, multicultural settings.
Knowledge of related disciplines: clinical operations, safety, biostatistics, regulatory affairs, pre-clinical research, pharmacology, and quality assurance.
Familiarity with IT tools, clinical trial systems, and agile decision-making processes.
Experience Required
7+ years of leadership experience in clinical development, with proven success in managing global programs and high-complexity trials.
Hands-on experience in Phase 3/pivotal trial design, safety oversight, regulatory interactions, and cross-functional team leadership.
Demonstrated track record of driving clinical strategy, mentoring teams, and ensuring high-quality clinical execution.
Work Arrangement & Benefits
Global travel may be required.
Relocation support available based on business needs.
Annual base salary range: $254,100 – $403,400, with participation in Pfizer’s Global Performance Plan (25% bonus target) and long-term incentive programs.
Comprehensive benefits including 401(k) with company contributions, paid vacation, caregiver/parental leave, and health coverage.
Why Pfizer
Pfizer is an equal opportunity employer committed to diversity, inclusion, and global compliance with employment laws. Join a collaborative environment where your clinical leadership drives innovation, ensures patient safety, and supports the advancement of global healthcare.
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