Director, Clinical Development Medical Director (MD Required)

Role Summary

The Director, Clinical Development Medical Director (MD Required) is responsible for the medical and scientific integrity of clinical trials and the well-being of patients enrolled. The role ensures high-quality trial design and execution, applies medical expertise to deliver clinical and operational excellence, and partners with clinical operations and other functions to deliver timely, quality protocols and trial outcomes. The position may involve matrix management across R&D teams and requires strong medical monitoring and leadership across medium-to-high complexity studies.

Responsibilities

• Performs medical monitoring on one or more clinical trials.
• Provides study-related medical information and assistance on investigator questions, safety findings, adverse events, audits/inspections, and quality assessments.
• Collaborates with clinical colleagues to conduct periodic safety data reviews and ongoing clinical/medical data reviews.
• Reviews safety text and endorses significant medical changes in informed consent documents.
• Leads clinical execution of studies with medium to high complexity and significant business impact; may be accountable for program-level clinical deliverables.
• Contributes to protocol design and development, ensuring efficient protocols and maximal operational efficiency, trial quality, and participant/site engagement.
• Leads protocol amendments and related communications; contributes to data collection tool development and input to SAP, TLFs, and BDR.
• Authors and approves informed consent documents and responds to external stakeholder questions.
• Develops and approves the Integrated Quality Management Plan; establishes Data Monitoring Committees and endpoint adjudication committees.
• Contributes to risk management and safety review planning; collaborates with stakeholders to implement mitigations.
• Reviews country/site selection criteria and contributes to site training materials.
• Acts as primary contact for external investigators and internal study teams on protocol-related questions.
• Reviews protocol deviations, patient-level and cumulative data, safety data, SAE reports, and ensures TMF compliance.
• Supports the Clinical Study Report, narratives, and contributes to primary publications; may assist in regulatory filings as needed.
• Provides clinical support during audits/inspections and may respond to regulatory queries and CTAs as required.
• Contributes to continuous improvement and innovative approaches for trial execution; may provide matrix management support to clinical colleagues.

Qualifications

• Obtained a primary medical degree (MD, DO, MBBS, MBChB) with a minimum of 4 years of Clinical Development experience in industry/CRO.
• 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 scientific productivity (publications, posters, abstracts, presentations).
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
• Strong clinical/medical, administrative, and project management capabilities with excellent English communication skills.
• Experience establishing, managing, and training teams in clinical development.

Preferred Qualifications

• Cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.).
• Diverse leadership experiences, with ability to influence, coach, and guide colleagues to achieve outcomes and business impact.

Education

• Primary medical degree (MD/DO/MBBS/MBChB) from a recognized medical school.

Additional Requirements

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