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

Role Summary

Executive Medical Director, Clinical Development, Advanced Pipeline Unit (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 IPF, PPF and autoimmune-associated ILDs such as CTD-ILD. Reports to the Vice President, Clinical Research Head in Respiratory. Partners with project teams to plan and deliver clinical research and development activities and to foster collaboration across all stages of development.

Responsibilities

• Lead the clinical development strategy for 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 clinical development plans and provide strategic oversight and management of clinical trials.
• Contribute to the Integrated Evidence Strategy (IES), overseeing the CDP and its component trials, integrating scientific rationale, regulatory requirements, product development plans, and commercial goals.
• Drive clinical development timelines for complex assets with decision points, risk/cost analyses, and Go/No Go criteria; lead evaluations of probability of technical success and assess risk-benefit with mitigation strategies as needed.
• Foster collaboration with Commercial, Regulatory, Clinical Operations, Medical Affairs, and Statistics; serve as the clinical point of contact for senior management, matrix teams, regulators, payors, CROs, consultants, and investigators.
• Lead clinical development discussions and teams at global regulatory interactions; draft clinical components of regulatory submissions (IND, NDA, BLA, MAA) including briefing documents, presentations, and responses to questions.
• Manage technical and leadership development of Clinical Development staff through direct line management, mentoring, and coaching.
• Drive strategic initiatives, business development activities, and organizational initiatives in Clinical Development; promote innovative methodologies and digital tools and encourage adoption of new ways of working.
• Stay informed of advancements in therapeutic area research, trial methodologies, competitive landscape, and regulatory space to maintain competitive edge.

Qualifications

• Required: Medical degree and clinical medical specialty training board qualification/registration.
• Required: Experience in the global pharmaceutical/biotechnology industry in the field of Interstitial Lung Diseases, including IPF, PPF, and CTD-ILD.
• Required: Experience in clinical research and drug development with a focus on ILDs; late-stage Lung Disease drug development including Phase 2 and Phase 3 design, initiation, execution, and closure; experience leading NDA, BLA, or MAA submissions and managing global trials; and familiarity with biostatistics to support data-driven decision rules.
• Required: Line-management experience overseeing medical directors/clinical scientists and leading matrix teams within a clinical development setting.
• Preferred: Medical degree and board qualification/registration in Pulmonary Medicine/Pulmonary & Critical Care.
• Preferred: Thorough understanding of respiratory diseases, biology, and potential therapeutic targets; robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements; understanding of regulators’, payers’, and prescribers’ needs in global markets; strong stakeholder relationship track record.
• Preferred: Strong problem-solving, strategic-thinking, and communication skills; ability to navigate ambiguity and drive cross-organizational opportunities; enterprise mindset for synergy across the organization; capability to analyze and interpret complex data for regulatory approvals and patient benefit.

Additional Requirements

• On-site presence required (minimum two days per week) at one of GSK’s US or UK sites (US: PA or MA; UK: London or Stevenage).