Vice President Program Management

Position Overview

The Vice President of Program Management drives the strategic and operational execution of the company's late-stage (Phase 3) development program. This position will report to the CEO and is a key member of the leadership team. This individual will drive integrated program strategy, execution and decision making partnering closely with cross-functional leaders to ensure clinical and regulatory success, and deliver critical value inflection points in a lean, fast-paced biotech environment.

This role requires a highly experienced, hands-on leader with deep expertise in late-stage clinical development, who can successfully navigate complexity, manage cross functional relationships, and prepare programs for potential registration and commercialization.

Key Responsibilities

• Lead the end-to-end program strategy and execution for Phase 2 and Phase 3 programs.
• Lead team cross functional team meetings to drive decision making and timelines by synthesizing complexity into clear decision options and plans of action.
• Contribute to development strategies to support regulatory approval, label optimization, and lifecycle planning.
• Ensure clear alignment of program goals with corporate objectives, investor expectations, and clinical/regulatory milestones.
• Oversee integrated program plans supporting global Phase 2b/3 clinical trials, including timelines, budgets, and critical path activities.
• Partner closely with Clinical Development, Clinical Operations, Biostatistics, Regulatory and CMC to ensure trial execution excellence.
• Anticipate and proactively mitigate risks related to enrollment, endpoints, regulatory expectations, and data integrity.
• Prepare and deliver communications for Board meetings highlighting key risks, risk mitigation strategies, and progress against timelines and deliverables.
• Support development of target product profiles and differentiation strategies in competitive immunology markets.
• Ensure programs are aligned with future commercialization considerations (e.g., payer expectations, labeling, and evidence generation).

Cross-Functional Leadership

• Act as the central driver of alignment across functions including Clinical, Regulatory, CMC, Commercial, and Quality.
• Lead program governance meetings and ensure timely, high-quality decision-making.
• Ensure accountability, performance, and integration of external activities into overall program execution.

Operational Infrastructure & Governance

• Establish fit-for-purpose program management frameworks tailored to late-stage development in a small biotech setting.
• Develop clear and concise program reporting for executive leadership, Board of Directors, and investors.
• Drive scenario planning and contingency strategies to enable rapid decision-making.

Leadership & Team Development

• Build and lead a small, high-performing Program Management team.
• Serve as a "player-coach," remaining deeply engaged in program execution while developing team capabilities.
• Foster a culture of urgency, accountability, and collaboration.

Education & Experience

• Bachelor's degree required; Advance degree preferred (PhD, PharmD, MS, MBA)
• 15+ years in biotech/pharma with substantial experience in late-stage clinical development.
• Demonstrated leadership of Phase 2 and Phase 3 programs, including global trials.
• Prior experience in immunology, allergy/inflammation, or respiratory diseases strongly preferred.
• Experience in small biotech or startup environments highly desirable.
• Strong knowledge of immunology clinical endpoints, biomarkers, and competitive landscape.
• Experience with regulatory filings (BLA/NDA/MAA) and health authority interactions.