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

Role Summary

Senior Medical Director, Clinical Development, Advanced Pipeline Unit (APU) Neurodegeneration – 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). Plan and ensure delivery of clinical research and development activities, and establish efficient collaboration throughout all stages of development. Report to the Vice President, Clinical Research Head, Neurodegeneration. Role supports delivering transformative medicines with clinical excellence, regulatory compliance, and operational efficiency, inspiring and empowering teams to achieve exceptional outcomes.

Responsibilities

• 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 competitive edge.

Qualifications

• 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 drug development, with a focus on Alzheimer’s Dementia
• Experience in late-stage neurodegeneration drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure
• Experience in leading NDA, BLA, or MAA submissions and managing global clinical trials in the field of neurodegenerative disease
• Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules
• Matrix team leadership experience within a clinical development setting

Skills

• Neurology/Neurodegeneration expertise; understanding of Alzheimer’s Dementia biology and targets
• ICH/GCP knowledge; regulatory and reimbursement data requirements
• Strategic thinking, problem-solving, and stakeholder management
• Strong communication and leadership in cross-functional matrices
• Ability to analyze complex data, forecast, and develop strategic approaches

Education

• Medical degree and clinical specialty training; Neurology board qualification preferred
• Additional certifications in regulatory affairs or clinical development are a plus

Additional Requirements

• On-site presence requirement in one of GSK’s US sites (minimum two days per week)