Senior Director, ATC Launch & Authorization

immatics; United States; Hybrid; USD 250,000 - 290,000; Full time

Job summary

Immatics is seeking a Senior Director, ATC Operations to lead the design and stand up the ATC authorization program across the US. You will build the program, lead a team, and activate the first wave of centers by launch readiness, with remote work flexibility and occasional on-site presence in Stafford, TX.

The role requires a clinical/biomedical degree, 12+ years in biotech/pharma, and 5+ years in cellular therapy operations, plus deep knowledge of FACT standards and COI/COC concepts.

Qualifications

• Bachelor's degree in a clinical, life sciences or healthcare administration field.
• 12+ years of relevant experience in biotechnology or pharmaceutical industry.
• 5+ years of direct experience in cellular therapy operations - either at a treatment center 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.

Responsibilities

• Authorization framework design.
• Design 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 activation.
• Support 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 users.
• Partner 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 handling.
• Support manufacturer-side oversight of chain of identity and

Education

Bachelor's degree in a clinical, life sciences or healthcare administration field

Job description

Immatics is seeking a Senior Director, ATC Operations to lead the design and stand up the ATC authorization program across the US. You will build the program, lead a team, and activate the first wave of centers by launch readiness, with remote work flexibility and occasional on-site presence in Stafford, TX.

The role requires a clinical/biomedical degree, 12+ years in biotech/pharma, and 5+ years in cellular therapy operations, plus deep knowledge of FACT standards and COI/COC concepts.