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

GSK•Waltham, MA

12d•Onsite

About The Position

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. About RIIRU: 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). Hear from Emma in conversation with Tonya Winders, President and CEO of the Global Allergy and Airways Patient Platform, and Dr. Jean Wright, CEO of the COPD foundation Go Behind the Science with our new article featuring Dr Kaivan Khavandi, as he talks about the importance of our respiratory innovation for COPD patients Read more from Tony Wood as he explains the importance of prevention in respiratory care Read our curtain raiser press release summarizing our key data 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.

Requirements

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.

Nice To Haves

Medical degree and clinical medical specialty training board qualification/registration in Neurology.
Thorough understanding of neurodegeneration including Alzheimer’s Dementia and the underlying biology and potential therapeutic targets.
Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements
Solid understanding of needs and priorities of regulators, payers and prescribers in relevant global market(s).
Track record of building and maintaining strong relationships with internal and external stakeholders.
Demonstrated strong problem-solving skills and innovative thinking.
Anticipate potential challenges, develop strategic approaches, and effectively communicate uncertainty to stakeholders while guiding teams through unclear circumstances.
Have an enterprise mindset by identifying opportunities for synergy across the organization.
Ability to use strategic thinking to analyze, interpret, and critically evaluate complex data and information.
Anticipate obstacles and identify innovative solutions to ensure timely delivery of evidence that supports regulatory approvals and patient benefit.
Navigate ambiguity by anticipating regulatory challenges and proactively addressing issues.

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 GSK’s competitive edge.

Benefits

Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

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