Director, Clinical Development Medical Director (MD Required)

Role Summary

The Director, Clinical Development Medical Director (MD Required) is responsible for ensuring the medical and scientific integrity of clinical trials, leading protocol development and execution, and providing medical monitoring and leadership across studies within one or more disease areas.

Responsibilities

• Performs medical monitoring on one or more clinical trials.
• Provides study-related medical information and assistance on investigator questions, safety findings, SAEs, audits, and quality assessments.
• Conducts periodic safety data reviews and ongoing clinical/medical data review with colleagues.
• Endorses significant medical changes in informed consent and leads clinical execution of studies with medium to high complexity and potential program-level impact.
• Supports development of protocol design documents (PDD) and leads protocol development to maximize operational efficiency, trial quality, and site engagement.
• Leads protocol amendments, letters to investigators, and data collection tool development; provides input to SAP, TLFs, and BDR.
• Authors and approves Informed Consent Documents and assists with IQMP development and approval.
• Establishes Data Monitoring Committees and endpoint adjudication committees; manages risk with stakeholders to implement mitigations.
• Reviews country/site selection and contributes to site training materials; acts as primary contact for external investigators and internal study team on protocol-related questions.
• Reviews and manages protocol deviations and data across studies; tracks SAEs and leads safety data presentations.
• Serves as medical monitor for trials; ensures TMF compliance; supports regulatory submissions and trial disclosures as needed.
• Contributes to continuous improvement and may provide matrix management support to clinical colleagues.

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/house officer/foundation 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 leading and training clinical development teams.

Preferred Qualifications

• Cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.).
• Demonstrated breadth of leadership experiences, including influencing peers, coaching others, and guiding cross-functional teams to achieve meaningful outcomes.

Skills

• Medical monitoring and safety data review
• Protocol design and amendment development
• Regulatory knowledge (ICH/GCP) and data management input
• Cross-functional collaboration and stakeholder management
• Scientific writing and publication support

Education

• Medical degree (MD, DO, MBBS, MBChB) from a recognized medical school/university

Additional Requirements

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