Senior Vice President, Head of Clinical Operations,

Job Summary

We are seeking a dynamic and experienced leader to guide the strategic and operational execution of our expanding clinical pipeline and portfolio in serious pulmonary and vascular diseases. The ideal candidate will be a hands-on leader with deep expertise in respiratory clinical development and a proven track record of overseeing multiple programs from early to late phase in the US and globally.

Reporting to the Chief Development Officer of Clinical, this individual will help shape the future strategy, structure, and culture of Clinical Operations, influence corporate strategy, and lead innovative global clinical programs. The role involves managing a growing internal team and a network of external partners and consultants, ensuring flawless clinical execution across all active and planned programs.

Responsibilities

Leadership & Strategy

• Define and implement the long-term vision, organizational design, and operating model for Clinical Operations.
• Build, lead, and mentor a high-performing team capable of scaling with company growth.
• Serve as a trusted member of the R&D leadership team, collaborating closely with Clinical Development, Regulatory, CMC, Clinical Quality, and Commercial functions and colleagues.
• Serve as a strategic advisor to the executive leadership team.
• Evaluate and implement emerging technologies and innovative trial methodologies to improve efficiency and patient experience.

Clinical Execution

• Oversee planning, execution, and delivery of multiple concurrent clinical programs across different stages of development, including supporting investigator-led and post-marketing studies.
• Lead global study expansion, including country/region selection, feasibility, site activation, and oversight of regional CROs and vendors; ensure compliance with local regulations, ethics committee requirements, import/export (IP, samples), and data privacy laws.
• Drive operational excellence, ensuring programs are delivered on time, within budget, and in compliance with global GCP standards.
• Optimize vendor relationships (CROs, central labs, data management, etc.) for quality, accountability, and efficiency.
• Ensure consistency across and within clinical programs.

Operational Oversight

• Develop and manage departmental budgets, forecasts, and resource plans.
• Implement metrics and dashboards to monitor performance, quality, and risk across studies.
• Champion process improvement and innovation, introducing scalable tools and best practices.

Cross-Functional Collaboration

• Partner with Clinical Development, Regulatory Affairs, Safety and Pharmacovigilance, Clinical Quality, and Program Management to align operational strategy with corporate goals.
• Contribute to program governance, study design input, and clinical strategy discussions.
• Represent Clinical Operations in regulatory and partner interactions as needed.

Requirements

• Bachelor’s degree required, preferably in a related field.
• 15 years of progressive experience in clinical operations leadership within biotech or pharma.
• Demonstrated success overseeing 5 clinical programs (Phase I–IV) simultaneously.
• Proven experience leading multi-regional/global trials (e.g., U.S., EU, and APAC), including start-up through close-out.
• Deep understanding of pulmonary/respiratory therapeutic areas required.
• Proven ability to scale teams and establish efficient organizational structures.
• Strong vendor management, budgeting, and operational governance experience.
• Collaborative, decisive leader with exceptional communication and change management skills.
• Based in or willing to travel frequently to the Raleigh–Durham (RTP) area preferred; or East Coast candidates.

Location

This position is based in Morrisville, NC, a thriving area known for its vibrant community and proximity to the Research Triangle Park, offering a dynamic environment for professionals seeking growth and innovation.