Clinical Development Medical Director (MD required)

Role Summary

The Clinical Development Medical Director role ensures medical and scientific integrity and participant wellbeing in clinical trials. It involves designing and executing high-quality studies, maintaining compliance, managing risks and emerging clinical/medical issues, and supporting interpretation and communication of clinical data. The role serves as the primary medical contact for protocol-related clinical and medical aspects and may include matrix management and strategic development support.

Responsibilities

• Leadership: Autonomously leads clinical execution of studies of medium to high complexity with significant business impact; may be accountable for program-level clinical deliverables; contributes to continuous improvement and may provide matrix management support to clinical colleagues.
• Content Creation: Provides clinical input for protocol design; leads development of the protocol from the approved PDD; ensures efficient protocols that maximize operational efficiency, trial quality, and participant/site engagement; supports governance reviews; leads protocol amendments and Dear Investigator Letters.
• Documentation: Authors and manages approval of Informed Consent Documents; handles responses to external stakeholder questions.
• Medical Monitoring & Safety Oversight: Performs medical monitoring; provides study-related medical information and assistance (investigators, site personnel, and non-study health care providers); manages safety findings, SAE/TME/ DME events, and audit/inspection responses; contributes to data collection tools; provides input to SAP, TLFs, and BDR; establishes DMCs and endpoint adjudication committees; develops IQMP; reviews risk management plans; ensures site training materials are prepared; serves as primary contact for clinical/medical protocol questions; conducts periodic safety data reviews and supports medical changes in ICD; tracks SAEs and ensures TMF compliance.
• Clinical Reporting: May contribute to regulatory filings; supports responses to regulatory queries and CTAs; reviews Clinical Study Reports and narratives; supports safety/efficacy data disclosure and trial conclusions; contributes to primary publications; provides clinical support during audits or inspections.

Qualifications

• Required: Primary medical degree (MD/DO/MBBS/MBChB) from a recognized medical school.
• Required: 4+ years of experience in biopharmaceutical industry clinical research and development.
• Required: Licensed to prescribe medicines independently for at least 2 years post internship; in good standing with Medical Licensing Authority.
• Required: Clinical research experience in phase 3/pivotal space.
• Required: Demonstrated scientific writing skills; publications, posters, abstracts, and/or presentations.
• Required: Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
• Required: Demonstrated clinical/medical, administrative, and project management capabilities; excellent verbal and written communication in English; ability to collaborate with internal and external stakeholders.
• Required: Demonstrated experience establishing, managing, and training teams in clinical development.
• Preferred: Oncology experience highly preferred.
• Preferred: Broad leadership capabilities including influence, coaching, and guiding others to achieve outcomes and business impact.
• Preferred: Passion for helping patients; strong analytical skills with large data sets.
• Preferred: Effective communication, presentation, and organizational skills; global perspective and ability to work in diverse teams with internal/external partners.
• Preferred: Solid understanding of related disciplines (clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, QA); IT proficiency; adaptability to changing environments.
• Preferred: Demonstrates problem-solving, agile decision-making, and proactive, independent work; ability to build partnerships and promote innovation.

Skills

• Strategic leadership and cross-functional collaboration
• Scientific writing and data interpretation
• Excellent written and verbal communication in English
• Analytical thinking and ability to manage large data sets
• Project management and risk mitigation
• Technical proficiency with IT tools and data systems

Education

• Primary medical degree (MD/DO/MBBS/MBChB) from a recognized medical school.

Additional Requirements

• Travel: Global travel may be required.
• Location: Hybrid role requiring residence within commuting distance and on-site attendance approximately 2.5 days per week; relocation support available.