Note: The job is a remote job and is open to candidates in USA. Uniquity Bio is a clinical-stage biotechnology company committed to developing transformative new medicines for immune-mediated diseases. The Vice President of Program Management will drive the strategic and operational execution of the company’s late-stage development programs, ensuring clinical and regulatory success while partnering closely with cross-functional leaders.
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
- Collaborate with Regulatory Affairs to prepare for key interactions (e.g., End-of-Phase 2, pre-BLA/NDA meetings, and global regulatory submissions)
- 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)
- 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
- 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
- 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
Skills
- Bachelor's degree required
- 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
- Experience with regulatory filings (BLA/NDA/MAA) and health authority interactions
- Proven ability to lead complex, cross-functional programs in a matrix environment
- Highly hands-on with the ability to operate at both strategic and tactical levels
- Strong risk management, problem-solving, and decision-making capabilities
- Exceptional communication skills, including Board-level presentations
- Advance degree preferred (PhD, PharmD, MS, MBA)
- Prior experience in immunology, allergy/inflammation, or respiratory diseases strongly preferred
- Experience in small biotech or startup environments highly desirable
- Deep understanding of TSLP biology or related epithelial cytokine pathways preferred
- Strong knowledge of immunology clinical endpoints, biomarkers, and competitive landscape
Company Overview