Clinical Development Senior Medical Director - Vascular

Job description

Job Description For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029. Working model: This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days. Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary You will lead clinical development medical activities for vascular programmes across early and later phase studies. You will work closely with colleagues in clinical operations, translational science, regulatory, safety, and commercial teams. We value clear clinical judgement, collaborative leadership and a focus on patient impact. You will shape clinical plans that accelerate safe, meaningful medicines to people with vascular disease while growing your career and influence at GSK. Join us to unite science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: In the Respiratory, Immunology, and Inflammation Research Unit (RIIRU), our enduring purpose is to leverage immune science to address underlying organ dysfunction and disease. We are trailblazing a pipeline of medicines to dramatically improve how we cure and care for patients. We are a diverse team of industry-leading experts who channel our passion for scientific exploration into true value for patients and GSK. We drive the end-to-end R&D journey, fuelling early discovery and our mid-stage pipeline while also advancing our late-stage medicines to launch. We are combining field-leading data sets, capabilities and methods with decades of knowledge, to transform our success in how we innovate new medicines. We are seeking experienced a Clinical Development Senior Medical Director to join the Cardiovascular Medicine group in GSK’s Respiratory, Immunology & Inflammation Research Unit. The group focusses on translation and early clinical development of programmes in heart failure and atherosclerotic disease, particularly in people with comorbid chronic inflammatory disease. In addition to providing clinical and scientific leadership to clinical and translational studies or programmes for asset-level projects, you will contribute to the assessment of potential mechanisms and targets, target validation programs, life-cycle expansion and innovative clinical development opportunities. You will work cross-functionally to develop and execute clinical development plans (CDPs) and contribute to above-project development of foundational and real-world data, and translational and biomarker capabilities, within a department that prioritizes understanding mechanism and unmet need alongside innovative clinical development, helping us deliver differentiated medicines that change the course of disease and improve patients’ lives. What you’ll do: • Lead the formulation of translational and clinical plans and study designs with project strategies to ensure quality design and execution of the CDP. Develop sections of core regulatory documents. • Generate the data and evidence required to determine a target’s potential efficacy, safety profile, key areas of differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe. • Define and deliver the clinical pillars of the translational table. Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and go/no-go criteria for the CDP. • Establish and maintain relationships with program counterparts in biology, translational sciences, commercial, regulatory, clinical operations, market access, medical affairs and statistics. • Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development. Clinical Development Strategy and Study & Program Design • Provide effective and experienced support and oversight of R&D evidence generation strategy, plan and activities to ensure patient safety and on-time, in-full study delivery. • Contribute to the study team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc.) to contribute to vital deliverables including early medicine profile, target validation, translational plans, candidate selection. • Lead the design of clinical development plans, study protocols and associated documents across all phases of development, reflecting internal and external stakeholder input (e.g., patients, evidence generation, regulators, payors, pharmacovigilance), with an emphasis on early development. • Bring clinical expertise to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs. • Provide medical monitoring and oversight of the safety of study participants on behalf of the sponsor during the study, together with pharmacovigilance physician. You will be accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study. Clinical Leadership • Accountable for leading the clinical matrix team (CMT) for a program. Serve as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study, and represent the CMT at early/medicine development teams. • Actively lead the end-to-end clinical development strategy for an early program and may contribute to later stages. • Serve as the primary clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators and with the relevant internal review boards (e.g., technical review or governance) and/or Protocol Review Board. • Lead clinical evaluation of business development opportunities. • Remain abreast of advancements in research, clinical trial methodologies, competitive environment and regulatory space in the relevant disease area to maintain GSK’s competitive edge, and disseminate information about recent advances to the relevant GSK colleagues. • Identify and highlight transformational opportunities for GSK program, for example where projects can offer highly significant benefit to patients in ways not possible with existing approaches. • Oversee the gathering and support the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the medicine profile. • Consistently contribute to solving study and overall clinical development challenges, including leading through others. • Demonstrate ability to lead and influence others at project, departmental and inter-departmental levels, as appropriate. Creating Innovative Scientific and Technical Solutions • Embrace challenge as an oppor