Job Information
GlaxoSmithKline LLC VP Clinical Research Head, Neurology Therapeutic Areas in Collegeville, Pennsylvania
Reference #: 414492 Site Name: USA - Massachusetts - Waltham, USA - California - San Francisco, USA - Pennsylvania - Upper Providence Posted Date: Jan 31 2025
Are you energized by a medical leadership role that allows you to drive and shape GSK's Neurology strategy and programs across the full discovery and development lifecycle? If so, the Vice President, Clinical Research Head, Neurology Therapeutic Areas role could be an exciting opportunity to explore.
GSK is seeking an exceptional leader in translational medicine and clinical development to join as VP Clinical Research Head (CRH) for Neurology within the Respiratory & Immunology Unit (RIRU). This senior role offers the opportunity to provide leadership throughout the discovery and development lifecycle, collaborating closely with biology and translational sciences leaders, and overseeing early to late-stage clinical development (Ph1 through Ph3) of Neurology programs. The role will help define the overall strategy for integrating new areas into the R&D pipeline, with a focus on Renal and Neurosciences, and identifying other promising scientific areas. Responsibilities also include setting disease area strategies, ensuring quality and robustness of medicine vision, integrated evidence plans, and innovative trials to support the development, approval, commercialization, and patient access to differentiated medicines, and potentially overseeing Medical Governance for clinical programs.
About RIRU: The Respiratory & Immunology Research Unit (RIRU) 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 biology unit within RIRU (aka RIBU) works across multiple therapy areas including neurodegenerative, immune, and metabolic disease. Neurodegenerative disease portfolio includes projects in Alzheimer's, Parkinson's, and ALS. The remit of RIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform up to Phase 2 studies in clinic. This goal is enabled through strategic external (23andMe, UK Biobank, FinnGen, Laboratory of Genomic Research, Public-Private Consortia like Accelerated Medicines Partnership, GSK-Oxford University joint Institute for Molecular and Computational Medicine, Biotech partnerships - Alector, Vesalius, Muna Therapeutics) and GSK-internal partnerships (Research Technologies).
This career opportunity requires an on-site office presence (minimum of two days a week) in one of GSK's US (preferred - Upper Providence, PA or Waltham, MA) or (considered - San Franscico, CA) sites.
Responsibilities include This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Build a portfolio of programs within Neurology TAs that have clear potential for product differentiation, tractability in development and with associated technical success probabilities that can support investment decisions. Act as single point of accountability for disease area strategy developed with input from internal GSK leaders & external academic thought leaders, research leads, regulatory authorities, investigators, and patient groups. Key leader involved in inputting/recommending milestone transitions from candidate selection through to commit to file/launch, and guiding team of Early and Late Clinical Leads to employ optimized translational and clinical strategies for programs, including optionality for alternative development pathways, enabling smart risk-taking by decision-makers for assets with indications in the disease area. Provide Medical Governance with accountability for managing and mentoring clinical staff and ensuring compliance with internal and external policies, guidance, laws, and codes. Develop and mainta n excellence in translational and clinical leadership in the disease area through talent identification, recruitment, development, and retention, to support the pipeline and marketed portfolio. Ensure quality of clinical deliverables within the disease area including all documents and submissions including clinical data, through methods such as peer review, knowledge sharing/management, and standards and compliance. Function as Data Steward of the clinical data for the disease area (may include multiple assets), with oversight of breadth of disease data strategies and related data science efforts relevant to Neurology TAs, to ensure activities are applied to benefit and impact of programs. Manage resourcing of Clinical projects within the disease area across the assets in scope including portfolio projects and programs (encompassing early projects prior to candidate selection, through early and late-stage clinical development) and business development/due diligence activities).
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Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Medical degree with specialty training in neurology. Experience across translational medicine and early clinical development (first-in-human trials & proof of mechanism), Ph2 (proof of concept), and Ph3 (registrational studies), with experience leading regulatory interactions and submissions across these phases (pre-IND/IND, scientific advice, end-of-phase 2, pre-NDA/BLA and files, advisory committee meetings). Experience in designing and executing clinical strategies, including advanced trial designs (adaptive and platform trials). Leadership experience in organizational transformation and change implementation, in a large and matrixed organization. Experience leading projects that harness digital, technological, and statistical tools and with accountability to support early-stage programs in the disease area by bringing in disease insights and clinical research expertise. Experience of clinical safety and pharmacovigilance, evaluation of safety signals, and proactive risk management strategies, gained through serving as safety risk lead, or as a clinical leader accountable for cross-functional deliverables. Experience with the local and global pharmaceutical industry, competitive landscape, how end-to-end life, and revenue cycles operate. Experience serving as representative on joint oversight committees for strategic external partnerships, and co-development arrangements.
Preferred Qualifications: If you have the following characteristics, it would be a plus: Medical degree with specialty training in neurology and PhD. Experience in leveraging expert knowledge for scientific, technical, clinical, and regulatory strategic thinking, problem solving and decision making in the evolving healthcare and digital data environments. A talented and experienced leader motivated by the desire to make a difference in patients' lives. Experienced people management, leadership, and motivational skills. Including stakeholder management, across scientific, academic, regulatory, and political communities to identify and achieve mutual goals for the well-being of patients and our communities. Ability to think and plan uniquely and strategically, to collaborate with members of other functions within a matrix environment. Intrigued by innovation, creativity, and new opportunities to gain experience. Energized by delivering ambitious standards through collaboration and motivating others across the organization. Committed to maintaining the highest compliance standards.
The annual base salary for new hires in this position ranges