Sr. Director, ATC Operations

3 weeks ago

Houston, TX, United States Immatics Full-time

JoinImmaticsandshape thefuture ofcancerimmunotherapy; one patient at atimeImmaticsis committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting ofPRAME, a target expressed in more than 50 cancers. Ourcutting-edgescience and robust clinical pipeline form the broadestPRAMEfranchise with the mostPRAMEindications and modalities, spanning TCR T-cell therapies and TCRbispecifics.
Why Join Us?Innovative Environment:Helptopioneeradvancementsincancer immunotherapy.
Collaborative Culture:Be part ofa diverse team dedicated to yourprofessionalgrowth.
Global Impact:Contribute to therapiesthatmakealastingimpactonpatientsglobally.
Role OverviewWe 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 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 pipelineReports to: VP, Launch Excellence, Strategy, & OperationsLocation: Fully Remote (with as-needed on-site presence at Immatics US, Stafford, TX)Salary Range: $250,000
- $290,000Basic QualificationsBachelor’s degree in a clinical, life sciences or healthcare administration field12+ years of relevant experience in biotechnology or pharmaceutical industry5+ years of direct experience in cellular therapy operations — either at a treatment center (cell therapy program management, apheresis, cell processing laboratory, IEC quality, or transplant/cell therapy nursing) or in a manufacturer role authorizing and supporting treatment centers.
Working knowledge of FACT Immune Effector Cell Standards, chain of identity and chain of custody requirements, and GTP/GMP concepts as they apply at the point of care.
Preferred QualificationsAn advanced clinical degree (MSN, MHA, PharmD, MPH)Clinical background (e.g., RN, NP, PA, PharmD, MSW)Experience building an authorization or site qualification programLaunch experience with an autologous cell therapy, including the first wave of center activationsHands-on experience with leukapheresis workflows and treatment-center operations for cell therapyDemonstrated leadership and ownership of treatment center qualification, onboarding, training, and/or audit activities across commercial-stage or late-stage clinical cell or gene therapy programs.
In-depth understanding of treatment center workflows, cell therapy coordination, apheresis, and chain-of-identity / chain-of-custody logisticsWorking knowledge of ASTCT 80/20 Task Force guidance, FACT accreditation and inspection processes, and/or center-level REMS implementationTrack record of writing SOPs and quality documentation and of handling deviations and CAPAs.
In this role you will be responsible for:Authorization framework designDesign the ATC authorization program: qualification criteria, risk-based assessment tooling, ongoing monitoring, requalification triggers, suspension or disqualification pathway, and ongoing monitoring plans.
Develop the SOPs governing ATC authorization, authorized-user training and system access, product receipt and handling, and deviation escalation.
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.
Center qualification and activationSupport the site selection and prioritization process; ATC target list, activation sequence and readiness tracker.
Lead comprehensive remote and on-site treatment-center qualification assessments, evaluating readiness across clinical care, leukapheresis, cell processing, pharmacy, cryostorage, and toxicity-management infrastructure.
Report ATC readiness into launch governance; own the authorization line on the integrated launch readiness plan and flag critical-path risk early and unambiguously.
Training and authorized usersPartner cross-functionally to develop and deliver the treatment-center training curriculum for physicians, nurses, cell therapy coordinators, apheresis teams, and quality personnel. Lead delivery and documentation of treatment-center training, maintain the authorized-user registry, and oversee access to product ordering and chain-of-identity systems. Establish retraining triggers.
Chain of identity (COI), chain of custody (COC) and product handlingSupport manufacturer-side oversight of chain of identity and chain of custody at the treatment center and ensure maintenance of COI/COC.
Define and verify cente