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

Role Summary

Executive Medical Director, Clinical Development, Advanced Pipeline Unit (APU) Respiratory responsible for clinical and scientific leadership for potential new, established and emerging ILD indications, including IPF, PPF, and CTD-ILD, across all stages of development. Reports to the VP, Clinical Research Head in Respiratory. Focus on delivering clinical excellence, regulatory compliance, and operational efficiency, while inspiring teams to achieve exceptional outcomes.

Responsibilities

• Lead the clinical development strategy for a drug/program, including accountability for the clinical components of the Target Medicine Profile (TMP) and leadership of the clinical matrix team (CMT). Develop cohesive and comprehensive clinical development plans (CDP) for products/indications and provide strategic oversight and management of clinical trials.
• Contribute to the Integrated Evidence Strategy (IES), overseeing the CDP and its component trials; align 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 PTRS evaluations and assess risk-benefit with mitigation strategies as needed.
• Foster collaboration with Commercial, Regulatory, Clinical Operations, Medical Affairs, and Statistics; serve as clinical point of contact for senior management, matrix teams, regulators, payors, CROs, consultants, and investigators.
• Lead clinical development discussions at global regulatory interactions and draft clinical components of regulatory submissions/files (e.g., IND, NDA, BLA, MAA).
• Manage technical and leadership development of Clinical Development staff through direct line management, mentoring, and coaching.
• Drive strategic initiatives, BD activities, and organizational initiatives in Clinical Development; promote innovative methodologies and digital tools.
• Stay informed of advancements in respiratory/ILD research, trial methodologies, competition, and regulatory space to maintain competitive edge.

Qualifications

• Mandatory: Medical degree and clinical specialty training board qualification/registration.
• Experience in global pharma/biotech with a focus on Interstitial Lung Diseases (ILD), including IPF, PPF, and CTD-ILD.
• Experience in clinical research and drug development for ILDs; late-stage lung disease drug development including Phase 2/3 trial design, initiation, execution, and closure.
• Experience leading NDA/BLA/MAA submissions and managing global clinical trials; familiarity with biostatistics and data-driven decision rules.
• Line-management experience overseeing medical directors/clinical scientists and leading matrix teams in a clinical development setting.

Preferred Qualifications

• Medical degree with board qualification/registration in Pulmonary Medicine/Pulmonary & Critical Care.
• Deep understanding of respiratory diseases, biology, and potential targets; strong knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements.
• Strong relationships with regulators, payers, prescribers; demonstrated problem-solving and innovative thinking; enterprise mindset for cross-organizational synergy.
• Strategic thinker with ability to analyze complex data, anticipate obstacles, and propose innovative solutions to support regulatory approvals and patient benefit.
• Ability to navigate ambiguity and proactively address regulatory challenges.

Education

• Medical degree with clinical specialty training; board certification/registration as applicable.