Vice President, Program Management
Uniquity Bio · Malvern, PA · 6 days ago
On-siteInformation TechnologyFull-time
Position Overview
Key Responsibilities
Cross-Functional Leadership
Qualifications
Leadership & Execution Skills
Requirements
Benefits
Pay
Schedule
- 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).
Qualifications
- 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.
- Deep understanding of TSLP biology or related epithelial cytokine pathways preferred.
- Strong knowledge of immunology clinical endpoints, biomarkers, and competitive landscape.
- Experience with regulatory filings (BLA/NDA/MAA) and health authority interactions.
Leadership & Execution Skills
- 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.
Requirements
- Self-motivated and capable of working both independently and collaboratively.
- Ability to work in a complex, collaborative environment.
- Experience in a similar role.
Benefits
- Flexible work arrangements.
- Competitive compensation package.
- Health insurance coverage.
- Retirement savings plan.
- Professional development opportunities.
Pay
- Salary range: $180,000 - $250,000 per year.
Schedule
- Full-time position.
- Office-based work with occasional travel.