Director / Senior Director, Program Management

Tr1X • San Diego, CA

1d • Onsite

About The Position

The Director/Senior Director, Program Management provides strategic leadership and performs hands-on operational activities supporting cell therapy programs in autoimmune indications. This individual aligns cross-functional teams, manages dependencies and risks, and ensures programs deliver against milestones and organizational objectives. The Director/Senior Director partners closely with Clinical Development, Clinical Operations, Regulatory, Technical Operations and R&D, along with external partners to drive execution of complex preclinical and clinical programs from early development through registrational studies.

Requirements

• A minimum BA/BS and 10+ yrs in a relevant Program/Project management role supporting drug development; advanced degree (Ph.D., MS, MD) and/or PM Certification strongly preferred.
• Exceptional communication skills (in person and written word) and the ability to interact and directly engage with a diverse group of individuals.
• Extensive experience managing and partnering with contract development and manufacturing organizations in the cell and gene therapy space.
• Experience on the sponsor side with cell or gene therapy development programs required.
• Experience applying the principles, concepts, practices, and standards of project management for drug development.
• Ability to understand and communicate scientific and business elements associated with Tr1X's engineered Tr1 Treg cell therapies is a must.
• Strong skills in management of external stakeholders and ability to influence and guide them toward decisions and outcomes that support company goals.
• Excellent interpersonal skills, ability to develop relationships with key internal and external stakeholders, and effective conflict management skills.
• Results and detail-oriented for achievement of program timeline and deliverables; self-motivated, ability to work with minimal supervision.
• Ability to adapt and perform in a fast-paced environment under tight deadlines.
• Strong analytical and problem-solving capabilities.
• Legally authorized to work for any employer in the U.S.

Nice To Haves

• advanced degree (Ph.D., MS, MD) and/or PM Certification strongly preferred.

Responsibilities

• Translate program strategy into integrated timelines, milestones, and deliverables, ensuring coordination across all contributing functions.
• Provide program/project management expertise and support to advance Tr1X's Tr1, CAR-Tr1 and in vivo cell therapy programs.
• Provide program management of one or more highly complex R&D programs and/or high-profile partnerships.
• Communicate with project team members, management leadership team, department heads, and key stakeholders including KOLs.
• Track and monitor key milestones and decision points to drive delivery of project objectives.
• Develop and refine tools for project governance and program timelines, as well as the communication of program KPIs, risks and achievements.
• Manage the interfaces between cross-functional teams and ensure effective handoff and communication between department functions.
• Lead cross-functional program management activities supporting autoimmune clinical development programs.
• Develop and maintain integrated clinical development plans, timelines, milestones, budgets, and risk management strategies across multiple functional areas.
• Partner with Clinical and senior leadership to support development strategy, indication prioritization, and pipeline programming.
• Ensure program activities support regulatory milestones including INDs, protocol amendments, health authority interactions, and potential BLA/MAA submissions.
• Partner with Clinical Operations to proactively identify enrollment, operational, and site-performance risks and implement mitigation strategies to ensure on time and on budget study recruitment.
• Ensure seamless coordination between clinical and CMC activities supporting cell therapy manufacturing, supply planning, patient scheduling, and supply chain/delivery logistics.
• Facilitate governance meetings, cross-functional team meetings including program team meetings, clinical strategy meetings and executive program reviews.
• Collaborate with Clinical Development, Regulatory and Medical Writing teams to support preparation of grants, posters, presentations and external-facing materials.
• Establish and maintain program dashboards, KPIs, and governance frameworks to ensure transparency and accountability.
• Support budget forecasting, scenario planning, and resource prioritization across the entire pipeline.
• Perform other responsibilities based on business needs.

Benefits

• discretionary annual target bonus
• incentive stock options
• 401(k) retirement plan with company contribution
• health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance
• paid time off (PTO)
• paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Senior