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 skills to design efficient, high-quality trials, employing quantitative design principles and clinical best practices to deliver clinical and operational excellence. The role ensures effective execution of studies, collaborates with clinical and medical colleagues, clinical operations, and other functions, and supports interpretation and communication of trial data. Additional responsibilities include risk mitigation, medical monitoring, and serving as the primary contact for external investigators and internal study teams on clinical/medical aspects of the protocol.

Responsibilities

• Performs medical monitoring on one or more clinical trials.
• Provides study-related medical information and assistance on: medical questions from investigators and site personnel, safety findings and complex SAE management, audits or inspection responses, and final quality event assessments.
• Conducts periodic safety data reviews with clinical colleagues and reviews safety text, endorsing significant changes in the Informed Consent Document.
• Leads clinical execution of studies of medium-high complexity and may be accountable for program-level clinical deliverables.
• Provides input to protocol design documents and leads protocol development to maximize operational efficiency, trial quality, and site engagement, while minimizing amendments or quality issues.
• Leads protocol amendments and related communications (PAB, Dear Investigator Letters).
• Provides input to data collection tools and to SAP, TLFs, and BDR; manages ICD approvals and responses to stakeholder questions.
• Develops and approves the Integrated Quality Management Plan (IQMP). Establishes Data Monitoring Committees and endpoint adjudication committees, and ensures documentation of outcomes.
• Reviews risk management plans and safety reviews, partners with stakeholders to mitigate risk.
• Reviews country and site selection criteria and contributes to site training materials.
• Serves as the primary contact with external investigators and internal study teams for protocol-related questions.
• Reviews and manages protocol deviations; reviews patient-level and cumulative data per the data review plan; tracks SAEs and presents data at Safety Review Team meetings.
• Acts as medical monitor for trials; ensures TMF compliance for clinical documents.
• Inputs to and reviews the Clinical Study Report; supports disclosure of safety and efficacy data and contributes to primary publications.
• Provides clinical support during audits or inspections and may contribute to regulatory filings if required.
• Supports responses to regulatory queries and audit findings; contributes to continuous improvement in trial execution.

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 period; in good standing with Medical Licensing Authority.
• Clinical research experience in phase 3/pivotal space.
• Strong scientific writing skills with publications, posters, abstracts, or presentations.
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and AE management.
• Excellent verbal and written communication skills in English; experience managing and training teams in clinical development.

Preferred Qualifications

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

Additional Requirements

• Global travel may be required.
• Hybrid work arrangement: reside within commuting distance and on-site approximately 2.5 days per week.