Associate Director, Clinical Development Medical Director

The Associate Director, Clinical Development Medical Director is accountable for the medical and scientific integrity of a study and the wellbeing of patients enrolled in one or more clinical trials.

The role involves ensuring the design of efficient and high-quality clinical trials, employing quantitative design principles and clinical best practices to deliver both clinical and operational excellence.

Key responsibilities include:

• Performing medical monitoring on one or more clinical trials
• Providing study-related medical information and assistance
• Contributing to final significant quality event medical assessments
• Conducting and documenting periodic safety data reviews
• Reviewing required safety text and endorsing significant medical changes in the Informed Consent Document
• Leading or supporting development of the protocol from the approved Protocol Design Document (PDD)
• Providing clinical/medical input to support development of the protocol design document (PDD)
• Developing and implementing risk mitigations
• Reviewing and approving country selection, developing site selection criteria
• Serving as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol
• Reviewing, reporting and managing protocol deviations
• Tracking and reconciling serious adverse events (SAEs) across a study
• Ensuring TMF compliance for clinical documents
• Supporting disclosure of safety and efficacy data and trial conclusions
• Contributing to primary publication of clinical trial results

The ideal candidate has:

• A primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university
• Clinical Research experience in phase 3/pivotal space
• Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations
• Been licensed by a licensing body/health authority to prescribe medicines independent of Supervision for at least 2 years post their intern/house officer/foundation period

Preferred qualifications include:

• Clinical Research experience in industry/CRO
• Cardiometabolic disease experience
• Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
• Demonstrated clinical/medical, administrative, and project management capabilities
• Excellent verbal and written communication skills in English
• Experience using common AI tools

The annual base salary for this position ranges from $189,200.00 to $315,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share-based long-term incentive program.