Vice President, Head Clinical Development-Respiratory

Key Responsibilities

• Collaborate with the CMO, CSO, and CDO to define and execute clinical strategies across the development lifecycle.
• Lead the development and delivery of integrated Clinical Development Plans (CDPs) for pipeline assets.
• Provide medical and strategic leadership for all phases of clinical trial execution, including: Study design and protocol development, CRO and key vendor oversight, contribute pre-study operational readiness, clinical monitoring and safety review, data analysis, interpretation, and reporting.
• Work closely with Preclinical Development, Regulatory Affairs, Clinical Pharmacology, Biometrics, and Clinical Quality to ensure alignment and integration of development strategies.
• Manage external partnerships including CROs and specialized consultants.
• Oversee clinical data interpretation and ensure scientific validity of efficacy and safety conclusions.
• Guide the preparation and quality of critical documents, such as: Clinical Study Reports (CSRs), Regulatory submissions and briefing materials, Scientific publications and presentations.
• Monitor clinical safety across studies and escalate emerging trends per the Safety Review Plan.
• Ensure the integrity and quality of clinical data, including proper patient selection and robust endpoint assessments.
• Collaborate with clinical operations, biostatisticians and medical writers on timely and accurate data reporting.

Required Education And Experience

• MD or MD, PhD with a strong background in clinical research and development; specialty training in pulmonary medicine, strongly preferred.
• 10+ years documented industry experience in the design, conduct and analysis of Phase 1, 2 and 3 studies with a track record of ph2-3 stage testing in lung function and exacerbation studies in asthma and COPD field.

Required Knowledge, Skills, Abilities & Behaviors

• Ability to work well with peers, with the executive team, and external audiences such KOLs and regulatory bodies.
• Excellent presentation and medical writing skills.
• Ability to thrive in a fast-paced, highly entrepreneurial environment.
• Excellent interpersonal skills.
• 5+ years direct people management experience required.
• Ability to travel domestically and internationally (up to 15-20% of the time).