Role Summary
Vor Biopharma is seeking a highly motivated and experienced 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.
- Lead effective Program Team meetings and present program strategy to various audiences.
- Accountable for the cross-functional execution of one or more program strategy plans, independent of indication or asset.
- Manage program timeline, cost, quality, and risk mitigation as well as timely escalation where needed.
- Act as a leader in the clinical development organization to help build cross-portfolio capabilities; recognize challenges and innovate solutions, coach junior staff.
- Evaluate new assets, determine time to approval, risks, budget, and overall development plan.
- Manage the effective operations of Vor Bio cross-functional program teams focused on disease area programs.
- Proactively coordinate risk management and ensure contingency and/or risk mitigation plans are developed.
- 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.
- Drive development of the Program Strategy Plan with insights from cross-functional discussions.
- Facilitate business decisions by integrating cross-functional input and robust scenario analysis; communicate decisions to stakeholders.
- 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 develop contingency plans.
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.
- Strong knowledge in drug discovery and development and/or clinical research with solid understanding of project strategy and disease content.
- Experience with operational start-up into Registrational/Phase 3 trials across multiple regions (US, EU, Japan, China).
- 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.
Education
- Advanced degree preferred (PhD, MD, PharmD, or equivalent in life sciences).