Clinical Development Medical Director (MD required)

Role Summary

The Clinical Development Medical Director ensures medical and scientific integrity and the wellbeing of participants enrolled in clinical trials. They design and execute high-quality studies, maintain compliance, manage risks and emerging clinical issues, and support interpretation and communication of clinical data. This role serves as the primary contact for internal and external stakeholders regarding the clinical and medical aspects of the protocol and may provide matrix management to clinical colleagues.

Responsibilities

• Leadership: Autonomously leads clinical execution of one or more studies of medium to high complexity with significant business impact; may be accountable for program-level clinical deliverables; contributes to continuous improvement and process enhancements; may provide matrix management support to clinical colleagues.
• Content Creation: Provides clinical/medical input to protocol design documents; leads development of the protocol from the approved PDD to maximize operational efficiency, trial quality and participant/site engagement; partners with/s supports the Global Development Lead in governance review and approval; leads protocol amendments and related letters (Protocol Administrative Change Letters, Dear Investigator Letters).
• Informed Consent and Oversight: Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions; clinical and safety oversight responsibilities.
• Medical Monitoring and Data Tools: Performs medical monitoring on one or more trials; provides study-related medical information and assistance on investigator/site questions, safety findings, SAE/TD events, audits or inspection responses; provides input to data collection tools; contributes to SAP, TLFs, BDR; establishes DMCs and endpoint adjudication committees; contributes to IQMP; leads risk management and safety review activities; reviews country/site selection and site training materials; serves as primary contact for protocol-related clinical/medical questions; conducts safety data reviews and ongoing clinical/medical data reviews; updates ICDs as needed; tracks SAEs and TMEs/DMEs; ensures TMF compliance.
• Clinical Reporting: May contribute to regulatory filings and responses; supports preparation of Clinical Study Reports and dissemination of safety/efficacy data; contributes to primary publication of trial results; provides clinical support during audits or inspections.

Qualifications

• Required: Primary medical degree (MD/DO/MBBS/MBChB) from a recognized medical school; 4+ years of experience in biopharmaceutical clinical R&D; licensed to prescribe medicines independently for at least 2 years post-internship; in good standing with the Medical Licensing Authority.
• Required: Clinical research experience in phase 3/pivotal space; demonstrated scientific writing skills with publications/posters/abstracts/presentations; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management; strong clinical/medical, administrative, and project management capabilities; excellent verbal and written English communications; experience establishing, managing, and training clinical development teams.
• Preferred: Oncology experience; breadth of leadership experiences and ability to influence, coach, and guide others to achieve outcomes and business impact; passion for helping patients; strong analytical skills with large data sets; effective communication, presentation, and organizational skills; global perspective and ability to work with diverse cultures and geographies; solid understanding of related disciplines (clinical operations, safety, biostatistics, regulatory, study management, preclinical, pharmacology, QA); proficiency with basic IT and adaptability to changing environments; demonstrated problem-solving, agile decision-making, partnership-building, collaboration, and proactive independent work.

Additional Requirements

• Global travel may be required.
• Hybrid work location: must live within commuting distance; on-site approximately 2.5 days per week.
• Relocation support available.