Sr. Director, ATC Operations

About the role

We are seeking a Senior Director, ATC Operations to lead the design and stand up the Immatics Authorized Treatment Center (ATC) authorization program including the qualification standard, the SOPs, the training curriculum, the chain of identity and chain of custody controls, the ongoing monitoring and audit plans, and lead the execution across the US authorized treatment center network. The program will be designed and operated in partnership with other areas, including but not limited to Global Patient Supplies and Global Quality Operation. The final allocation of responsibilities between those functions and ATC Operations is being confirmed as part of Immatics’ clinical-to-commercial transition and will be finalized before the role is filled. The successful candidate will design and build the program and lead a team to activate the first wave of ATCs by launch readiness, and grow a team to sustain the ongoing authorization pipeline.

Responsibilities

• Authorization framework design: Design the anzu-cel ATC authorization program (qualification criteria, risk-based assessment tooling, ongoing monitoring, requalification triggers, suspension/disqualification pathway, ongoing monitoring plans); Develop SOPs governing ATC authorization, authorized-user training and system access, product receipt and handling, deviation escalation; Partner with Regulatory Affairs and Quality to align authorization approach with BLA risk‑mitigation strategy and prepare for health authority questions; Benchmark and harmonize treatment‑center requirements with ASTCT 80/20 Task Force recommendations, FACT Immune Effector Cell Standards, existing center accreditation, and other manufacturer requirements, justifying any Immatics‑specific requirements.
• Center qualification and activation: Support site selection and prioritization (ATC target list, activation sequence, readiness tracker); Lead comprehensive remote and on‑site treatment‑center qualification assessments (clinical care, leukapheresis, cell processing, pharmacy, cryostorage, toxicity‑management infrastructure); Assessment and authorization of the apheresis unit conducted with Global Patient Supply per the roles‑and‑responsibilities model; Drive centers to activation by closing qualification gaps and confirming readiness for first patient; Report ATC readiness into launch governance, own the authorization line on the integrated launch readiness plan, and flag critical‑path risk early.
• Training and authorized users: Partner cross‑functionally to develop and deliver the anzu‑cel treatment‑center training curriculum for physicians, nurses, cell therapy coordinators, apheresis teams, and quality personnel; Lead delivery and documentation of training, maintain the authorized‑user registry, oversee access to product ordering and chain‑of‑identity systems; Establish retraining triggers for label changes, process changes, staff turnover, and post‑deviation remediation.
• Chain of identity