Immatics

Manager

• Author, review, and maintain CMC and GMP documentation in accordance with regulatory requirements and industry best practices
• Prepare and review technical and GMP documentation supporting development, manufacturing, technology transfer, validation, and PPQ activities
• Support late-stage GMP manufacturing, commercial readiness, and PPQ execution
• Collaborate with CDMOs, CROs, Qualified Persons (QPs), and internal stakeholders to ensure successful program delivery
• Contribute to CMC content for BLA, NDA, and other global regulatory submissions
• Act as a key scientific subject matter expert (SME), supporting manufacturing investigations, technical issue resolution, and technology transfer activities
• Partner with CMC Biologics, Regulatory Affairs, Quality Assurance, and Project Management teams to ensure milestones, supply continuity, and compliance
• Maintain effective communication with internal and external stakeholders

Senior Manager, CMC Biologics

Director

• Lead strategic engagement with national and large regional payers in both the commercial and government segments (e.g., UnitedHealthcare, Aetna, Anthem, Cigna, Aetna, Elevance/Anthem, BCBS Plans, State Medicaid Agencies, etc.)
• Build and manage relationships with key decision-makers across payer organizations, including key pharmacy and medical stakeholders
• Effectively and efficiently engage with all key targeted accounts while making key prioritization decisions
• Analyze current treatment guidelines, competitive landscape, and relevant coverage policies to anticipate payer needs and potential barriers, while setting expectations on acceptable future coverage for anzu-cel (TCR-T cell therapy) and other future Immatics’ products
• Develop and execute early account engagement plans in anticipation of launch, educating payer stakeholders on Immatics, our unique science targeting PRAME, cell therapy process, disease state burden, and anzu-cel value proposition
• Partner with internal teams (Market Access Strategy, Contracts and Pricing, HEOR, Medical Affairs, Clinical, Regulatory) to develop and tailor payer-facing materials, including early scientific exchange, evidence dossiers, PIE and Value Proposition presentations, and budget impact model
• Drive payer insight generation to inform pricing strategy, contracting models, and patient access programs in pre-launch and launch phases
• Influence the issuance of positive payer policies that enable appropriate patient access for anzu-cel and other future commercially available products without major patient specific impediments
• Ensure all engagements and materials are fully compliant with legal, regulatory, and corporate standards
• Travel Required: Up to 50%, including partner meetings, conferences, and internal cross-functional workshops

Senior Director, Payer Accounts

Research Analyst

• Support clinical trial site management and monitoring activities
• Perform and support on-site monitoring visits
• Support the maintenance and updating of trial-specific tracking tools
• Collect site-specific clinical trial documents
• Support Trial Master File filing activities and TMF completeness checks
• Contribute to clinical trial site management and engagement
• Review patient recruitment progress and clinical data capture

Freelance Clinical Research Associate, CRA

• Develop and execute the patient access and support strategy for Immatics' cell and gene therapy portfolio.
• Build and lead patient support programs that facilitate timely therapy access and deliver an exceptional patient and provider experience.
• Establish scalable operating models, processes, and capabilities to support commercial launch readiness.
• Lead cross-functional collaboration across internal stakeholders and external partners to ensure seamless patient journey coordination.
• Oversee patient navigation, reimbursement support, financial assistance, and access-related operations.
• Drive launch planning and execution, ensuring operational readiness and alignment with commercialization objectives.
• Develop performance metrics, governance structures, and continuous improvement initiatives to measure program effectiveness and patient outcomes.
• Serve as a key strategic advisor and leader within the broader Market Access organization.

Executive Director, Patient Access, Support

Compliance

• Serving as the primary U.S Regulatory expert for promotional materials through Immatics’ pipeline and any future commercial launches
• Chair and lead PRC, ensuring “fair balance,” alignment with Prescribing Information (PI), and compliance with scientific exchange and misbranding rules
• Ensure U.S advertising and promotional strategy consistency with FDCA, FDAMA, FD&C labelling, and OPDP guidance
• Prepare and file pre-clearance materials via Form FDA 2253, lead OPDP interactions, and respond to enforcement letters/advisories
• Support label negotiations for PI, carton/container, and PPI
• Review advertising copy, promotional claims, speaker programs, digital/social media materials, and HCP-facing promotions for FDA compliance
• Identify and remediate claims, manage recall and mitigation activities when necessary
• Mentor junior RA professionals; oversee operational delivery and resource allocation
• Manage budget for Ad/Promo activities and ensure cohesive execution across programs

Senior Manager, CMC Biologics

Senior Director, Payer Accounts

Freelance Clinical Research Associate, CRA

Executive Director, Patient Access, Support

Senior Director, Regulatory Affairs – Advertising & Promotion