Executive Medical Director, Clinical Development, Advanced Pipeline Unit (APU) Respiratory

Executive Medical Director, Clinical Development, APU Respiratory

GSK is seeking a highly skilled Executive Medical Director, Clinical Development, APU Respiratory to provide clinical and scientific leadership for potential new, established and emerging indications for assets in clinical development with a strong focus on Interstitial Lung Diseases (ILD) including Idiopathic pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF) and autoimmune associated ILDs including connective tissue disease Associated ILD (CTD-ILD). 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 in Respiratory. 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).

Key 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.

Basic Qualifications :

Preferred Qualifications :

Why GSK? Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas : respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.