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

Role Summary

Executive Medical Director, Clinical Development, Advanced Pipeline Unit (APU) Respiratory. 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 IPF, PPF and CTD-ILD. Plan and ensure delivery of clinical research and development activities, and establish efficient collaboration throughout all stages of development. Report to the Vice President, Clinical Research Head in Respiratory. Drive clinical excellence, regulatory compliance, and operational efficiency, inspiring and empowering teams to achieve exceptional outcomes.

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‚Äôs competitive edge.

Qualifications

• Medical degree and clinical medical specialty training board qualification/registration.
• Experience in the global pharmaceutical/biotechnology industry in the field of Interstitial Lung Diseases.
• Experience in IPF, PPF and autoimmune associated ILDs including CTD-ILD.
• Experience in clinical research and drug development, with a focus on ILDs.
• Experience in late-stage Lung Disease drug development, including Phase 2 and Phase 3 trial design, initiation, execution, and closure.
• Experience leading NDA, BLA, or MAA submissions and managing global clinical trials.
• Experience of clinical research methodology and biostatistics to facilitate innovative and efficient designs with data-driven decision rules.
• Line-management experience overseeing medical directors and/or clinical scientists and leading matrix teams within a clinical development setting.

Preferred Qualifications

• Medical degree and clinical medical specialty training board qualification/registration in Pulmonary Medicine/Pulmonary & Critical Care.
• Thorough understanding of respiratory diseases, underlying biology and potential therapeutic targets.
• Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements.
• Strong understanding of regulators, payers and prescribers needs in global markets.
• Track record of building and maintaining relationships with internal and external stakeholders.
• Strong problem-solving and innovative thinking; ability to navigate ambiguity and guide teams through uncertain circumstances.
• Enterprise mindset to identify synergies across the organization.
• Strategic thinking to analyze and interpret complex data; identify innovative solutions to support regulatory approvals and patient benefit.
• Ability to anticipate regulatory challenges and address issues proactively.