Director, Clinical Development Medical Director (MD Required)

Role Summary

The Director, Clinical Development Medical Director (MD Required) is accountable for the medical and scientific integrity of the study and the wellbeing of patients enrolled in clinical trials. The role applies technical and clinical/medical skills to design efficient, high-quality trials using quantitative design principles and clinical best practices to deliver clinical and operational excellence. The role ensures timely delivery of a quality protocol, clinical execution of large or complex trials, and interpretation and communication of trial data.

Responsibilities

• Performs medical monitoring on one or more clinical trials.
• Provides study-related medical information and assistance to investigators, site personnel, and non-study health care providers.
• Addresses safety findings, medical issues, and complex serious adverse events; supports audits or inspection medical responses.
• Contributes to final significant quality event medical assessments.
• Conducts periodic safety data reviews and ongoing clinical/medical data reviews with clinical colleagues.
• Reviews required safety text and endorses significant medical changes in the Informed Consent Document.
• Autonomously leads clinical execution of studies of medium to high complexity and significant business impact; may be accountable for program-level clinical deliverables.
• Provides clinical/medical input to the protocol design document (PDD) and leads protocol development to maximize operational efficiency, trial quality, and participant/site engagement; minimizes amendments or quality issues.
• Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides clinical/medical input to data collection tools; contributes to SAP, TLFs, and BDR.
• Authors and manages approval of Informed Consent Documents and responses to external stakeholder questions.
• Develops the Integrated Quality Management Plan (IQMP) and reviews/approves the final document.
• Establishes Data Monitoring Committees and endpoint adjudication committees, including chartering and documentation of outcomes.
• Reviews and approves Risk Management and Safety Review Plans; collaborates with stakeholders to mitigate risks.
• Reviews country/site selection criteria and contributes to site training materials.
• Serves as the primary contact with external investigators and internal study team for clinical/medical protocol questions.
• Reviews, reports, and manages protocol deviations; reviews patient-level and cumulative data per the data review plan.
• Monitors safety data, SAE reports, and ensures clinical documents (e.g., ICD) are updated; tracks and presents SAEs at Safety Review Team meetings.
• Acts as the medical monitor on trials and ensures TMF compliance for clinical documents.
• Reviews the Clinical Study Report and narratives; supports disclosure of safety and efficacy data and trial conclusions; contributes to primary publication of results.
• Provides clinical support during audits or inspections; may contribute to regulatory submissions if required.
• Contributes to continuous improvement and process enhancements in clinical trial execution.

Qualifications

• 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 internship/foundation period; in good standing with Medical Licensing Authority.
• Clinical research experience in phase 3/pivotal space.
• Demonstrated scientific writing skills and 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; excellent English communication skills.
• Experience establishing, managing, and training teams in clinical development.

Preferred Qualifications

• Cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.).
• Diversified leadership experience including influencing, coaching, and guiding others to achieve meaningful outcomes and business impact.

Additional Requirements

• Global travel may be required.
• Hybrid role requiring residence within commuting distance and on-site work about 2.5 days per week.