Senior Medical Director, Clinical Development, Advanced Pipeline Unit; APU), Neurodegeneration

GSK is seeking a highly skilled Senior Medical Director, Clinical Development, Advanced Pipeline Unit (APU) Neurodegeneration to provide clinical and scientific leadership for potential new, established and emerging indications for assets in clinical development with a strong focus on neurodegenerative disease including Alzheimer’s Dementia (AD). You will work with project teams to plan and ensure delivery of clinical research and development activities and establish efficient collaboration throughout all stages of development.

You will report to the Vice President, Clinical Research Head, Neurodegeneration. This role is pivotal in driving GSK’s mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency. The successful candidate will not only deliver results but also inspire and empower teams to achieve exceptional outcomes.

The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease based on the foundational observation that targets with human genetic evidence supporting their causal role in the intended indication improves clinical success by two-fold. The remit of RIIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals.

This goal is enabled through strategic external (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics and others) and GSK-internal partnerships (Research Technologies).

PLEASE NOTE:

This career opportunity requires an on-site office presence (minimum of two days a week) in one of GSK’s US (PA or MA) sites.

• Lead the clinical development strategy from a drug or program including accountability for the clinical components of the Target Medicine Profile (TMP) and leadership of the clinical matrix team (CMT). Ensure cohesive and comprehensive clinical development plans (CDP) for product(s) and/or indication(s) and provide strategic oversight and management of clinical trials. Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.
• Contribute to development of the Integrated Evidence Strategy (IES), including oversight of the CDP and its component clinical trials. Integrate scientific rationale, regulatory requirements, product development plans, and commercial goals to optimize asset indications and programs.
• Drive clinical development timelines for complex assets with clear decision points, risk/cost analyses, and Go/No Go criteria. Lead probability of technical success PTRS evaluations and assess study/project risk-benefit, implementing mitigation strategies as needed.
• Foster collaboration with Commercial, Regulatory, Clinical Operations, Medical Affairs, and Statistics teams. Act as the clinical point of contact for senior management, matrix teams, and external stakeholders, including regulators, payors, CROs, consultants, and investigators.
• Lead clinical development discussions and teams at global regulatory interactions. Draft clinical components of global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions.
• Manage technical and leadership development of Clinical Development staff via direct line management, mentoring and coaching across the organisation.
• Drive strategic initiatives, business development activities, and organizational initiatives in Clinical Development. Promote innovative methodologies and processes including digital tools, encouraging others to think differently and adopt new ways of working.
• Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK’s competitive edge.

#LI-GSK

• Medical degree and clinical medical specialty training board qualification/registration
• Experience in the global pharmaceutical/biotechnology industry in the field of Neurodegeneration.
• Experience in clinical research and…