Associate Director, Clinical Development Medical Director (MD Required)

Role Summary

The Associate Director, Clinical Development Medical Director provides medical and scientific leadership for clinical trials, ensuring integrity and quality of studies and patient wellbeing. The role partners with clinical and medical colleagues, operations, and other functions to deliver high-quality protocols and trial execution, while maintaining compliance and mitigating risks. The position serves as the primary contact for external investigators and internal study teams on clinical/medical aspects of the protocol and supports study and disease area strategy.

Responsibilities

• Performs medical monitoring on one or more clinical trials, including responding to investigator questions, safety findings, and complex adverse events; participates in audits or inspections and supports quality event assessments.
• Conducts periodic safety data reviews and ongoing clinical/medical data review with clinical colleagues; reviews safety text and endorses significant changes in informed consent documents.
• Provides clinical/medical input to protocol design documents (PDD) and leads or supports protocol development to maximize operational efficiency, trial quality, and site engagement; collaborates with Global Development Lead on governance and approval processes.
• Leads development of protocol amendments, letters to investigators, and data collection tools; provides clinical/medical input to SAP, TLFs, and BDR.
• Authors and manages approval of informed consent documents and responses to external stakeholder questions; contributes to IQMP and approves final document.
• Establishes Data Monitoring Committees and endpoint adjudication committees; supports risk management and safety review plans and implements mitigations with key stakeholders.
• Reviews country/site selection criteria and training materials; serves as primary contact for protocol-related clinical/medical questions; reviews protocol deviations and data per the data review plan.
• Reviews safety data, SAE reports, and related documents; tracks SAEs and presents data at Safety Review Team meetings; may act as medical monitor for trials.
• Ensures TMF compliance; contributes to Clinical Study Reports and supports safety/efficacy data disclosure; contributes to primary publication of results.
• Supports audits/inspections and regulatory filings as needed; contributes to responses to regulatory queries and CTAs; drives continuous improvement in trial execution.

Qualifications

• Required: Primary medical degree (MD, DO, MBBS, MBChB) and Clinical Research experience; licensed to prescribe medicines independently for at least 2 years post-internship; good standing with Medical Licensing Authority; clinical research experience in phase 3/pivotal space; demonstrated scientific writing skills and publications.
• Preferred: Industry/CRO clinical research experience; cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.); extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management; strong verbal/written communication in English; demonstrated leadership, project management, and ability to influence cross-functional teams.

Skills

• Medical monitoring and safety data review
• Protocol development and amendment leadership
• Data management and regulatory documentation (ICDs, SAP, TLFs, BDR, IQMP)
• Risk management and safety planning
• Regulatory submissions support and QA/audit response
• Strong communication and cross-functional collaboration

Education

• Medical degree (MD, DO, MBBS, MBChB) from an accredited school; active license to practice medicine

Additional Requirements

• Global travel may be required
• Hybrid work arrangement; on-site 2.5 days per week within commuting distance