Associate Director, Clinical Development Medical Director (MD Required)

Role Summary

The Associate Director, Clinical Development Medical Director is accountable for the medical and scientific integrity of the study and the wellbeing of patients enrolled in one or more clinical trials. The role applies technical and clinical/medical skills to ensure the design of efficient and high-quality clinical trials, employing quantitative design principles and clinical best practices to deliver both clinical and operational excellence. They are responsible for effective execution of studies, ensuring timely delivery of a quality protocol, and supporting interpretation and communication of clinical trial data. They maintain compliance with internal and external standards, proactively mitigate risk, and may perform medical monitoring of one or more trials. They serve as the primary contact with external investigators and internal study teams for clinical/medical questions and partner with the Global Development Lead on study and disease area strategy.

Responsibilities

• Performs medical monitoring on one or more clinical trials and provides study-related medical information and assistance (e.g., responses to medical questions from investigators, site personnel, and non-study health care providers; safety findings and SAE reviews; audits or inspection medical responses; significant quality event medical assessments).
• Conducts and documents periodic safety data reviews and ongoing clinical/medical data review; reviews safety text and endorses significant medical changes in the Informed Consent Document.
• Provides clinical/medical input to protocol design (PDD) and leads or supports protocol development to maximize operational efficiency, trial quality, and participant/site engagement while minimizing amendments or quality issues; partners with the Global Development Lead in governance review and approval.
• Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
• Provides clinical/medical input to data collection tools and to SAP, TLFs, and BDR.
• Authors and manages approval of Informed Consent Documents (ICDs) and responses to external stakeholder questions.
• Provides input to the Integrated Quality Management Plan (IQMP); reviews and approves the final document.
• Establishes Data Monitoring Committees and endpoint adjudication committees, including chartering and data provision; documents outcomes.
• Reviews and approves Risk Management and Safety Review Plan; ensures activities align with the approved plan and mitigates risks with stakeholders.
• Reviews country/site selection criteria and contributes to site training materials.
• Serves as primary contact for clinical/medical protocol questions; reviews, reports, and manages protocol deviations.
• Reviews patient-level and cumulative data per the data review plan; tracks SAEs and leads data presentation at Safety Review Team meetings.
• May act as medical monitor for one or more trials; ensures TMF compliance for clinical documents.
• Inputs and reviews the Clinical Study Report; supports disclosure of safety and efficacy data and trial conclusions; contributes to primary publications.
• Provides clinical support during audits/inspections; may contribute to regulatory filings (e.g., PIP, IB, IND/NDA Annual Reports, PSI, CTAs) if required.
• Contributes to continuous improvement and process enhancements to maximize trial execution effectiveness.

Qualifications

• Obtained a primary medical degree (MD, DO, MBBS, MBChB) and has Clinical Research experience.
• 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 with publications, posters, abstracts, or presentations.

Preferred Qualifications

• Clinical Research experience in industry/CRO.
• Cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.).
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
• Strong clinical/medical, administrative, and project management capabilities with excellent English communication skills.

Skills

• Medical monitoring
• Data review and safety management
• Regulatory and protocol development
• Stakeholder communication and collaboration
• Scriptwriting and documentation
• Risk management and quality assurance

Education

• Medical degree (MD/DO/MBBS/MBChB) required.

Additional Requirements

• Global travel may be required.
• This is a hybrid role; location must be within commuting distance and on-site about 2.5 days per week.