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Senior Medical Director, Clinical Development (Psychiatry)

APX Life Sciences

Senior Medical Director, Clinical Development (Psychiatry) APX Life Sciences is currently partnered with an established specialist biopharmaceutical company to appoint a Senior Medical Director, Clinical Development (Psychiatry) . This is a highly visible leadership opportunity within an innovative organisation focused on advancing therapies for neuropsychiatric disorders. The successful candidate will play a key role in shaping clinical development strategy across multiple programmes, working closely with senior leadership and cross-functional teams. Responsibilities include leading protocol design, providing medical oversight of clinical trials, supporting regulatory interactions, and representing the organisation externally with investigators, key opinion leaders, regulatory authorities, and scientific organisations. Key Responsibilities Lead the design, execution, and medical oversight of clinical development programmes in neuropsychiatric disorders. Serve as the Global Clinical Lead for one or more development programmes, providing scientific and strategic leadership to multidisciplinary project teams. Author and review clinical development documents, including study protocols, clinical study reports, investigator materials, regulatory submissions, and scientific publications. Provide medical monitoring and review of Phase II and Phase III clinical trial data in collaboration with CRO medical monitors. Partner with senior leadership to shape clinical development strategy and future indication prioritisation. Collaborate cross-functionally with teams including Regulatory Affairs, Clinical Operations, Translational Medicine, Clinical Pharmacology, Toxicology, CMC, Medical Affairs, Commercial, Market Access, Legal, Finance, and Project Management. Build and maintain relationships with investigators, key opinion leaders, patient advocacy organisations, and scientific collaborators globally. Support regulatory interactions, including INDs, NDAs, BLAs, and health authority meetings. Participate in investigator meetings, advisory boards, and major international scientific congresses. Mentor and develop junior clinical development colleagues where appropriate. Contribute to business development evaluations and due diligence activities as required. Candidate Profile MD (or equivalent medical degree) with significant clinical drug development experience in psychiatry or neuropsychiatry. Minimum of 5-7 years' experience within the pharmaceutical or biotechnology industry. Strong experience across early- and late-stage clinical development. Demonstrated success leading global clinical programmes and multidisciplinary teams. Experience interacting with global regulatory authorities and supporting successful regulatory submissions is highly desirable. Excellent written and verbal communication skills with the ability to engage effectively with executive leadership and external stakeholders. Strong strategic thinking, leadership, and collaborative skills. Comfortable working within a fast-paced, matrixed environment. Ability to prioritise multiple projects while maintaining high scientific and operational standards. Willingness to travel domestically and internationally (approximately 25%). Why Join? This is an opportunity to join an established, science-driven biopharmaceutical organisation developing innovative therapies for patients with serious neuropsychiatric disorders. The role offers significant strategic influence, broad cross-functional exposure, and the opportunity to shape the future direction of a growing clinical development organisation while working alongside experienced industry leaders. #J-18808-Ljbffr APX Life Sciences

Vacancy posted 4 days ago
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