Senior/Director, Program Management

Role Summary

Vor Biopharma is seeking a highly motivated and experienced Director/Senior Director, Program Management to oversee the strategic and operational management of a late-stage clinical program in autoimmune diseases. This individual will provide leadership across cross-functional teams to ensure successful execution of Phase 3 clinical trials, regulatory interactions, and preparation for potential product launch. The Director will play a pivotal role in aligning scientific, clinical, regulatory, and commercial strategies to drive the program forward in a fast-paced, small biotech environment.

Responsibilities

• Lead the overall strategy and execution of a global Phase 3 clinical program in autoimmune diseases.
• Serve as the accountable owner for program deliverables, timelines, and budget.
• Ensure alignment of program objectives with company goals and long-term strategy.
• Partner with Clinical Operations, Medical, Regulatory, and Biostatistics teams to ensure Phase 3 trial execution meets quality, compliance, and regulatory standards.
• Support preparation and submission of regulatory documents (NDA/BLA, briefing books, responses to regulatory queries).
• Oversee interactions with the FDA, EMA, and other global regulatory agencies.
• Lead cross-functional core teams (Clinical, Regulatory, CMC, Commercial, Medical Affairs) to ensure integrated program planning and decision-making.
• Provide clear communication of program progress, risks, and mitigation strategies to executive leadership and the Board of Directors.
• Collaborate with Commercial and Medical Affairs to prepare for launch readiness and market access planning.
• Manage relationships with CROs, investigators, advisory boards, and key opinion leaders in autoimmune diseases.
• Represent the company at scientific conferences, investor updates, and industry meetings as appropriate.
• Oversee program budgets, contracts, and resource planning.
• Identify risks and proactively develop contingency plans to maintain trial integrity and timelines.

Qualifications

• Advanced degree preferred (PhD, MD, PharmD, or equivalent in life sciences).
• 12+ years of biotech/pharma experience, with at least 5 years in program or project leadership.
• Proven track record leading late-stage (Phase 2/3) clinical programs, ideally in autoimmune or immunology-related indications.
• Experience in regulatory submissions (NDA/BLA) and health authority interactions.
• Demonstrated ability to thrive in a small-company, fast-paced environment with limited infrastructure.
• Strong leadership, strategic thinking, and communication skills.

Skills

• Visionary leadership with hands-on execution ability.
• Deep understanding of clinical development and regulatory pathways.
• Excellent cross-functional collaboration and influence.
• Entrepreneurial mindset and adaptability.
• High integrity and commitment to patients and compliance.