Associate Director, Clinical Development Medical Director (MD Required)

Role Summary

Associate Director, Clinical Development Medical Director. MD required. Provides medical and scientific leadership to ensure the integrity, quality, and safety of one or more clinical trials. Partners with clinical operations and other functions to deliver high-quality protocols, clinical execution, and data interpretation.

Responsibilities

• Performs medical monitoring on one or more clinical trials, providing study-related medical information and assistance (inquiries from investigators, site personnel, and non-study healthcare providers).
• Handles safety findings, medical issues, complex serious adverse events, audits or inspection medical responses, and contributes to final quality event medical assessments.
• conducts periodic safety data reviews and ongoing clinical/medical data reviews; endorses significant medical changes in the informed consent document.
• Provides clinical/medical input to protocol design documents and supports efficient protocol development to maximize operational efficiency, trial quality, and site engagement; collaborates with the Global Development Lead on governance.
• Leads or supports protocol amendments, administrative letters, and Dear Investigator Letters; contributes to data collection tools and clinical/medical input for SAP, TLFs, and BDR.
• Authors and manages approval of informed consent documents; provides input to the Integrated Quality Management Plan and aids in establishing Data Monitoring Committees and endpoint adjudication committees.
• Reviews and approves risk management and safety plans; ensures activities align with the approved plan and develops mitigations with key stakeholders.
• Reviews country/site selection, develops site training materials, and serves as the primary clinical/medical contact for protocol questions.
• Reviews protocol deviations and data; tracks SAEs; leads data presentations in Safety Review Team meetings; may act as medical monitor.
• Ensures TMF compliance; contributes to Clinical Study Reports, safety and efficacy disclosures, and primary publications of trial results.
• Provides clinical support during audits or inspections and may contribute to regulatory filings and responses as required.
• Contributes to continuous improvement and innovative approaches to maximize trial execution effectiveness.

Qualifications

• Required: Medical degree (MD, DO, MBBS, MBChB) with clinical research experience; licensed to prescribe medicines independent of supervision (at least 2 years post-internship); maintained medical license in good standing; clinical research experience in phase 3/pivotal space; demonstrated scientific writing productivity.
• Preferred: Industry/CRO clinical research experience; cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.); extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and AE management; strong English communication and project management skills.

Skills

• Clinical monitoring and safety data review
• Protocol development and amendment leadership
• Medical documentation: ICDs, SAPs, data tools
• Regulatory knowledge: ICH/GCP; safety reporting
• Scientific writing and publication support
• Cross-functional collaboration and stakeholder management

Education

• Medical degree from a recognized medical school/university

Additional Requirements

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