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, ensuring high-quality design and execution, and safeguarding patient wellbeing. The role involves medical monitoring, protocol development, risk management, and collaboration with internal and external stakeholders to deliver clinically meaningful trial outcomes.

Responsibilities

• Performs medical monitoring on one or more clinical trials.
• Provides study-related medical information and assistance on medical questions from investigators, site personnel, and non-study health care providers; safety findings and complex adverse events; audits or inspection medical responses; contributes to final quality event assessments.
• Conducts periodic safety data reviews with clinical colleagues and reviews ongoing clinical/medical data.
• 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.
• Leads development of protocol amendments and related communications (Protocol Administrative Change Letters, Dear Investigator Letters).
• Provides clinical input to data collection tools and documentation (SAP, TLFs, BDR); authors and manages approval of ICDs and responses to external questions.
• Provides input to IQMP; approves final document.
• Establishes Data Monitoring Committees and endpoint adjudication committees, including chartering and documentation of outcomes.
• Reviews and approves Risk Management and Safety Review Plan; collaborates with stakeholders to mitigate risks.
• Reviews country/site selection criteria and assists in site training materials; serves as primary contact for protocol-related questions.
• Reviews protocol deviations and analyzes patient-level and cumulative data; tracks SAEs and leads data presentation in safety meetings.
• Acts as the medical monitor for trials; ensures TMF compliance for clinical documents.
• Contributes to Clinical Study Reports and supports safety/efficacy data disclosure and primary publications.
• Provides clinical support during audits/inspections; may contribute to regulatory filings and responses if required.
• Contributes to continuous improvement initiatives and may provide matrix management support to clinical colleagues.

Qualifications

• Primary medical degree (MD/DO/MBBS/MBChB) with a minimum of 4 years in industry CRO Clinical Development experience.
• Licensed to prescribe medicines independently for at least 2 years post-intern period; active medical license in good standing.
• Clinical research experience in phase 3/pivotal space.
• Strong scientific writing ability; publication activity recommended.
• Extensive knowledge of clinical development, global/regional regulations, ICH/GCP, and adverse event management.
• Demonstrated clinical/medical, administrative, and project management capabilities with excellent English communication skills; experience leading and training teams in clinical development.

Skills

• Medical monitoring and safety data review
• Protocol development and amendment management
• Regulatory knowledge (ICH/GCP, AE management)
• Data collection tool development and SAP/BT/RBD input
• Stakeholder collaboration and cross-functional leadership
• Clinical Study Report preparation and publication support

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.