Position SummaryThe 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.
Key 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 Directors on protocol strategy, clinical endpoints, efficacy measures, biomarkers, and patient-reported outcomes relevant to autoimmune studies.
- Support competitive intelligence activities and maintain awareness of evolving autoimmune treatment landscapes, clinical trial designs, and emerging therapies.
- Partner with R&D, Clinical Development 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.
Required Qualifications & Experience- 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.
Other Requirements- Legally authorized to work for any employer in the U.S.
- Position is on-site in San Diego, CA
The job responsibilities and requirements provided above are intended to describe the general nature of the work performed by individuals assigned to this job classification. It is not intended to be an exhaustive list of all duties and requirements. Tr1X retains the right to add, change, or delete duties, education, experience or any other requirements of the position at any time.
