Clinical Development Medical Director (Director)

The Clinical Development Medical Director (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.

Responsibilities:

• Provides medical monitoring on one or more clinical trials
• Provides timely, study-related medical information and guidance
• Contributes to medical assessments of Quality Events
• Conducts and documents periodic safety data review and ongoing clinical/medical data review
• May independently lead clinical execution of one or more studies
• May provide input to the protocol design document
• Represents the study team in internal protocol review governance submissions and interactions
• Ensures development of Study Informed Consent Documents and responses to external stakeholder requests
• Provides clinical guidance to the development of the Statistical Analysis Plan and Tables, Listings, and Figures
• Provides clinical guidance to the development of the clinical data collection strategy, instruments, and data review plan
• Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan
• Establishes and manages External Data Monitoring Committees and Adjudication Committees
• Develops site selection criteria and provides clinical input to selection of sites
• Participates in investigator meeting planning and develops and delivers protocol training
• Serves as the primary clinical point of contact with investigators and study team
• Ensures protocol deviation sub-categories are established and reported
• Ensures TMF compliance for clinical documents
• Provides clinical input and review of the Clinical Study Report
• Ensures disclosure of safety and efficacy data and trial conclusions
• Provides clinical support to audits and inspections
• May contribute to clinical sections of regulatory filings
• Contributes to continuous improvement / process enhancement activities
• May have managerial responsibility for other clinical colleagues or contingent workers

Basic Qualifications:

• Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university
• 4+ years of experience in biopharmaceutical industry in clinical research and development
• Licensed by a licensing body/health authority to prescribe medicines independent of Supervision for at least 2 years

Preferred Qualifications:

• Cardiometabolic disease experience
• Maintained registration/Medical License to practice and always in good standing with Medical Licensing Authority
• Clinical research experience in biopharmaceutical industry
• Scientific productivity via publications, posters, abstracts, and/or presentations
• Extensive knowledge of clinical development, global and regional regulation, and ICH/GCP
• Clinical, administrative, and project management capabilities
• Experience launching, managing, and training clinical development teams
• Track record of achievement in pharmaceutical development
• Understands complexities and recent developments in principal disease areas
• Able to set priorities and manage cross-functional teams and complex projects
• Effective leader; able to mentor/coach, delegate to, and oversee others

Benefits:

• Comprehensive and generous benefits and programs
• 401(k) plan with Pfizer Matching Contributions and additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits, including medical, prescription drug, dental, and vision coverage

Salary Range: $239,900.00 - $399,800.00 per year Bonus Target: 25.0% of base salary Eligibility to participate in share-based long-term incentive program