Associate Director, Clinical Development Medical Director (MD Required)

Role Summary

The Associate Director, Clinical Development Medical Director is responsible for the medical and scientific integrity of clinical trials, ensuring high-quality designs and operational excellence. This role oversees study execution, partners with cross-functional teams, and supports interpretation and communication of clinical trial data. It maintains compliance with standards, mitigates risk, and may perform medical monitoring. The position acts as the primary contact for external investigators and internal study teams regarding clinical/medical aspects and collaborates with the Global Development Lead on strategy.

Responsibilities

• Performs medical monitoring on one or more clinical trials and provides study-related medical information and assistance on questions from investigators, site personnel, and non-study health care providers.
• Addresses safety findings, medical issues, complex serious adverse events, and audits or inspection medical responses; contributes to final quality event medical assessments.
• Conducts periodic safety data reviews and ongoing clinical/medical data reviews in collaboration with clinical colleagues.
• Reviews safety text and endorses significant medical changes in the Informed Consent Document; provides input to protocol design documents and supports efficient protocol development to maximize operational efficiency, trial quality, and site engagement.
• Leads or supports protocol amendments, administrative change letters, and Dear Investigator Letters; provides input to data collection tools and to SAP, TLFs, and BDR.
• Authors and manages approval of Informed Consent Documents; provides input to the Integrated Quality Management Plan and ensures its final approval.
• Establishes Data Monitoring Committees and endpoint adjudication committees; contributes to risk management and safety plans and ensures activities align with approved plans.
• Reviews country/site selection criteria and assists with site training materials; serves as primary contact for protocol-related questions with external investigators and internal teams.
• Reviews and manages protocol deviations; reviews patient-level and cumulative data; tracks SAEs and presents data at Safety Review Team meetings.
• May act as medical monitor; ensures TMF compliance; contributes to Clinical Study Reports and supports data disclosure and primary publications of results.
• Provides clinical support during audits/inspections and may contribute to regulatory filings and responses if required.
• Contributes to continuous improvement and innovative approaches to maximize trial effectiveness.

Qualifications

• Primary medical degree (MD, DO, MBBS, MBChB) with Clinical Research experience.
• Licensed to prescribe medicines independently for at least 2 years post-intern/house officer/foundation period; in good standing with Medical Licensing Authority.
• Clinical research experience in phase 3/pivotal space; demonstrated scientific writing skills and publications/presentations.

Preferred Qualifications

• Clinical research experience in industry/CRO; cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.).
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
• Strong clinical/medical, administrative, and project management capabilities with excellent English communication skills.

Skills

• Clinical trial medical monitoring
• Regulatory and safety reporting
• Protocol development and amendment management
• Data monitoring and risk management
• Cross-functional collaboration and stakeholder management

Education

• Medical degree from an accredited institution; relevant clinical research training or certification is a plus.

Additional Requirements

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