Vice President, Clinical Development

Role Summary

Vice President, Clinical Development responsible for leading clinical development strategy, medical oversight of trials, and collaboration with cross-functional teams in pulmonary therapeutics. Focused on molgramostim nebulizer solution, with responsibilities spanning regulatory input, safety oversight, and external collaborations.

Responsibilities

• Ensure an effective and high-performing clinical development function with adequate resources.
• Oversee clinical development activities: trial design, implementation, conduct and reporting, safety surveillance, and vendor oversight.
• Provide input into clinical development plans and trial protocols, including analysis plans, informed consent forms, CRFs, and clinical study reports.
• Oversee review of SAE reports for medical accuracy, causality, and expectedness.
• Function as or oversee the medical monitor for selected studies, ensuring medical oversight and pharmacovigilance alignment with available evidence.
• Collaborate with senior leaders to review and evaluate business development opportunities.
• Collaborate with Quality Assurance to create and update clinical development procedures.
• Serve as primary liaison with Clinical Operations to ensure timely delivery of milestones and data.
• Ensure cohesion with Medical Affairs and provide clinical support for publications, advisory boards, and presentations at medical congresses.
• Prepare or review documents for regulatory submissions, including CSR, safety summaries, overviews, and Investigator's Brochures.
• Support business development with clinical input, technical expertise, and medical evaluation of new indications; develop development plans and rationales.
• Keep up-to-date with medical knowledge through literature reviews and interactions with clinical experts.
• Maintain and expand the global clinical network with experts and key opinion leaders.
• Hire, provide feedback, monitor, manage performance, and coach direct reports.
• Other duties and projects as assigned.

Qualifications

• Doctorate degree (MD, DO) with 10+ years in pharmaceutical/biotechnology/clinical development, preferably in Pulmonary Medicine.
• Board certification in pulmonary medicine desirable.
• Ability to understand and effectively communicate scientific and medical information.
• Proven leadership skills.
• Excellent written and oral communication skills.
• Ability to anticipate and adapt to change; strong interpersonal skills for collaboration across functions.
• Ability to communicate well with health care professionals and establish relationships with peer groups and external parties.

Work Location and Travel

This role is US-based and requires the ability to work in the US Eastern Time Zone. Remote candidates within the US may be accepted; preference for greater Philadelphia area. Travel to the US HQ outside Philadelphia is required; other travel may be required quarterly.