Executive Director, Medicine Development Leader
The Association of Technology, Management and Applied Engineering, New York, New York, us, 10261
Position Summary
GSK is seeking a highly skilled Medicine Development Leader (MDL), to strategically lead the optimal global development of neurodegenerative medicine at an asset level. Acting as the single point of accountability for the medicine from clinical Proof of Concept (PoC) to Approval in the first major market(s). By working with the various stakeholders across GSK's Medicine Development matrix (R&D, Manufacturing, Commercial, etc.), the MDL will define the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy. 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. Our core therapeutic areas include Respiratory, Hepatology, Nephrology, Neurodegeneration and Rheumatology. 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) or UK (London or Stevenage) sites. Responsibilities
Lead the global development strategy for a medicine, ensuring alignment with organizational goals. Chair a cross-functional Medicine Development Team (MDT) to achieve clinical, regulatory, and commercial milestones. Make evidence-based decisions to prioritize and advance the medicine's portfolio options, including new indications. Ensure compliance with quality standards, risk management, and regulatory requirements. Incorporate patient insights into development plans to enhance patient focus. Represent the medicine to senior leadership, external stakeholders, and regulatory bodies. Post-approval, provide key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets. Partner with the Pipeline Project Manager (PPM), energize and motivate the MDT to drive a high-performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development, and smart risk-taking. Partner with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning, and CMC risk mitigation. Why you?
Basic Qualifications: Advanced degree including MD, PhD, PharmD, MBA, MS Extensive and broad experience in drug development expertise in the global pharmaceutical/biotechnology industry Filing experience with BLA/NDA/MAA submissions as a core responsibility. Strong leadership and decision-making skills and prior experience leading development programs. Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing Medical, and Commercial. Experience in product development and/or commercialization, in late-phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance. Preferred Qualifications: Experience leading teams in a complex, matrixed, global, and multi-disciplinary organization with high accountability, minimal authority, and multiple lines of reporting. Experience working with regulators and with regulatory requirements including legal and government frameworks within and across global geographies. Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process. Demonstration of a thorough understanding of the healthcare environment and access in all major markets. Deep experience building budgets and leading the strategic and budget planning process. 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. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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GSK is seeking a highly skilled Medicine Development Leader (MDL), to strategically lead the optimal global development of neurodegenerative medicine at an asset level. Acting as the single point of accountability for the medicine from clinical Proof of Concept (PoC) to Approval in the first major market(s). By working with the various stakeholders across GSK's Medicine Development matrix (R&D, Manufacturing, Commercial, etc.), the MDL will define the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy. 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. Our core therapeutic areas include Respiratory, Hepatology, Nephrology, Neurodegeneration and Rheumatology. 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) or UK (London or Stevenage) sites. Responsibilities
Lead the global development strategy for a medicine, ensuring alignment with organizational goals. Chair a cross-functional Medicine Development Team (MDT) to achieve clinical, regulatory, and commercial milestones. Make evidence-based decisions to prioritize and advance the medicine's portfolio options, including new indications. Ensure compliance with quality standards, risk management, and regulatory requirements. Incorporate patient insights into development plans to enhance patient focus. Represent the medicine to senior leadership, external stakeholders, and regulatory bodies. Post-approval, provide key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets. Partner with the Pipeline Project Manager (PPM), energize and motivate the MDT to drive a high-performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development, and smart risk-taking. Partner with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning, and CMC risk mitigation. Why you?
Basic Qualifications: Advanced degree including MD, PhD, PharmD, MBA, MS Extensive and broad experience in drug development expertise in the global pharmaceutical/biotechnology industry Filing experience with BLA/NDA/MAA submissions as a core responsibility. Strong leadership and decision-making skills and prior experience leading development programs. Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing Medical, and Commercial. Experience in product development and/or commercialization, in late-phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance. Preferred Qualifications: Experience leading teams in a complex, matrixed, global, and multi-disciplinary organization with high accountability, minimal authority, and multiple lines of reporting. Experience working with regulators and with regulatory requirements including legal and government frameworks within and across global geographies. Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process. Demonstration of a thorough understanding of the healthcare environment and access in all major markets. Deep experience building budgets and leading the strategic and budget planning process. 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. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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