Director Clinical Development
hace 5 días
City of London
Job Title: Clinical Development Medical Director (CDMD) Location: London / Hybrid (location flexible) Job Purpose The Clinical Development Medical Director (CDMD) is the global clinical leader for assigned programme-level activities and/or clinical trials, providing strategic medical and scientific leadership to ensure the successful delivery of clinical development objectives under the direction of the GPCH or Senior CDMD. Key Responsibilities • Provide clinical leadership and strategic medical input across assigned programme activities and deliverables, aligned to Integrated Development Plans (IDP) and Clinical Development Plans (CDP)., • Lead the development of clinical sections of regulatory and submission documents, including protocols, Investigator’s Brochures, briefing books, safety updates, submission dossiers, and Health Authority responses., • Drive execution of assigned clinical programme components in partnership with global line functions, Clinical Trial Heads (CTHs), and regional medical teams., • Provide medical oversight of clinical trials, acting as medical monitor where required, and contribute to data interpretation, Clinical Study Reports (CSRs), publications, and internal/external presentations., • Support overall benefit–risk assessment and safety monitoring, contributing to Safety Management Teams (SMTs) and safety deliverables such as PSURs, DSURs, and other regulatory safety reports in collaboration with Patient Safety., • Contribute medical expertise to IDP/CDP and Clinical Trial Protocol (CTP) reviews, and support development of disease-area clinical standards., • Represent the organisation as a medical and scientific expert in interactions with regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, and patient advocacy groups., • Support early development activities, including pre-Proof of Concept to Development Decision Point transitions, and provide medical input to Business Development & Licensing activities and due diligence as required., • Lead, mentor, and develop clinical colleagues and programme reports, supporting performance management, talent planning, onboarding, and training., • Contribute to medical and scientific training across the organisation and may act as a speaker for franchise or therapeutic-area training initiatives., • Participate in or lead global initiatives such as process improvement, SOP development, training, and other Clinical Development function activities., • Where assigned, act as Clinical Scientific Lead for individual clinical trials, providing end-to-end clinical leadership. Experience & Professional Requirements • ≥5 years’ experience in clinical research or global drug development (academic or industry), spanning Phases I–IV., • ≥3 years’ experience leading or contributing to global clinical trials in a pharmaceutical industry, matrixed environment; late-phase development experience preferred., • Advanced scientific and medical expertise, with strong ability to analyse and interpret clinical data and literature., • Deep knowledge of the assigned therapeutic area., • Strong understanding of ICH, GCP, clinical trial design, statistical methodologies, and regulatory development processes., • People management experience (≥1 year) required, including matrix leadership; global people management experience desirable., • Proven ability to operate effectively in a complex, global matrix organisation., • Excellent communication, interpersonal, negotiation, and conflict resolution skills. Why Join Us? This is a high-impact leadership role offering the opportunity to shape global clinical development strategy, influence regulatory success, and work at the forefront of innovative medicines that improve patient outcomes worldwide.