Director, Clinical Development Medical Director (MD Required)

Role Summary

Director, Clinical Development Medical Director (MD Required). Accountable for the medical and scientific integrity of the study and the wellbeing of patients enrolled in clinical trials. Applies clinical skills to design efficient, high-quality trials using quantitative design principles and best practices to deliver clinical and operational excellence. Responsible for effective execution of studies, timely delivery of quality protocols, and interpretation and communication of trial data. Maintains compliance with standards, mitigates risk, and performs medical monitoring. Primary contact for external investigators and internal study team on clinical/medical aspects; may provide matrix management support.

Responsibilities

• Performs medical monitoring on one or more clinical trials.
• Provides study-related medical information and assistance, including responses 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 quality event assessments.
• Collaborates with clinical colleagues to conduct periodic safety data reviews and ongoing clinical/medical data review.
• Reviews safety text and endorses significant medical changes in the Informed Consent Document.
• Leads clinical execution of studies of medium to high complexity and significant business impact; may be accountable for program-level clinical deliverables.
• Provides input to protocol design documents and leads development of protocols to maximize operational efficiency, trial quality, and participant/site engagement; supports governance review and approval process.
• Leads protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides input to data collection tools; contributes to SAP, TLFs, and BDR.
• Authorizes and manages approval of Informed Consent Documents; responds to external stakeholder questions.
• Inputs to Integrated Quality Management Plan and reviews/approves final document.
• Establishes Data Monitoring Committees and endpoint adjudication committees, including chartering, contracting, data provision, and outcome documentation.
• Implements Risk Management and Safety Review Plan with stakeholders to develop mitigations.
• Reviews country/site selection criteria and contributes to site training materials.
• Serves as primary contact for protocol-related questions; reviews, reports, and manages protocol deviations.
• Reviews patient-level and cumulative data per Data Review Plan; monitors safety data, SAE reports, and ensures clinical documents are updated; leads SAE presentation in Safety Review Team meetings.
• Acts as medical monitor for trials; ensures TMF compliance for clinical documents.
• Supports Clinical Study Reports and narratives; contributes to dissemination of safety and efficacy data and trial conclusions; may contribute to primary publications.
• Provides clinical support during audits or inspections; may contribute to regulatory filings if required; supports responses to regulatory queries and CTAs.
• Contributes to continuous improvement and process enhancements to maximize trial execution; may provide matrix management support to colleagues.

Qualifications

• MD, DO, MBBS, or MBChB from a recognized medical school; 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 period; current medical license in good standing.
• Clinical research experience in phase 3/pivotal space.
• Strong scientific writing skills; publications, posters, abstracts, or presentations.
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
• Excellent verbal and written communication skills in English; experience building and leading teams in clinical development.

Skills

• Medical monitoring and safety data review
• Protocol development and amendment management
• Data management tool input (PDD, SAP, TLFs, BDR, ICDs)
• Regulatory and quality systems knowledge
• Cross-functional collaboration and stakeholder management

Education

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

Additional Requirements

• Global travel may be required.
• Hybrid work model: on-site an average of 2.5 days per week within commuting distance.