Immatics

Compliance

• Develop, own, and continuously refine US clinical regulatory strategy aligned with global development plans and corporate objectives
• Serve as Regulatory Functional Lead for assigned US clinical programs, ensuring regulatory considerations are embedded in development decisions
• Lead preparation, strategy development, and execution of FDA interactions (e.g., INTERACT, pre-IND, Type B/C meetings, End-of-Phase meetings, pre-BLA meetings), including briefing document strategy and meeting facilitation
• Oversee and provide strategic direction for preparation and submission of INDs, amendments, annual reports, and future BLAs, ensuring scientific rigor and regulatory compliance
• Proactively identify regulatory risks and design mitigation strategies; escalate critical strategic issues only after evaluation of proposed solutions
• Ensure timely and high-quality responses to FDA requests for information and regulatory feedback
• Provide program-level regulatory updates, strategic assessments, and recommendations to senior management
• Drive cross-functional alignment across Clinical, CMC, Nonclinical, Regulatory Operations, and Commercial stakeholders
• Monitor and assess regulatory landscape and evolving FDA guidance relevant to cell and gene therapy products; translate intelligence into strategic recommendations
• Ensure regulatory timelines, deliverables, and submission milestones are achieved without need for day-to-day oversight
• Contribute to development of departmental standards, best practices, and strategic regulatory frameworks
• Model and promote a solution-oriented mindset within cross-functional teams

Director, Clinical Regulatory Affairs

Clinical Operations

• Provide strategy and operational leadership for Clinical Operations activities focusing on site management and systems
• Build, lead and inspire a high-performing Clinical Operations department within the scope of responsibilities
• Ensure timely and high-quality execution of clinical trials related to agreed timelines, budget, GCP compliance and quality
• Resource, budget Planning and Controlling Clinical Operations within the scope of activities
• Liaises with the VP Clinical Operations, Germany on budget planning
• Contribute to the global clinical development strategy in close collaboration with global cross-functional stakeholders
• Identify and mitigate operational risks proactively
• With the EU counterpart, implement scalable processes and systems that support growth and adaptability
• Champion innovation in clinical trial execution, including emerging tools and agile methodologies

Vice President, Clinical Operations

Clinical Research

• Collaborate with COL (Clinical Operations Lead) to set targets for clinical monitoring activities, and ensuring the recording of the trial in compliance with project goals
• Conduct and oversee the clinical trial site feasibility and site selection process
• Create, maintain and implement trial-specific plans, tools and documents required per SOP (Standard Operating Procedure) (e.g., training material, annotated trip reports, Clinical Monitoring Plan, Deviation Handling Plan)
• Oversee or perform collection of clinical trial site specific documents ensuring on time regulatory submissions (CA, IRB/IEC) according to local requirements
• Driving the clinical site initiation and greenlight process according to project goals
• Actively contribute to clinical trial site management and engagement to establish and maintain close site relationships
• Organize and oversee project-specific training for CRAs (Clinical Research Associate) and clinical trial sites
• Review trip reports and provide day-to-day expert advice to CRAs
• Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiates appropriate actions to achieve objectives
• Conduct Monitoring Oversight Visits ensuring clinical trial site and internal/external CRA (Clinical Research Associate) performance
• Manage protocol and GCP deviations as Deviation Manager according to SOP
• Proactively contributes to continuous improvement of Clinical Operation specific processes, procedure and templates

Clinical Trial Manager

Marketing

• Collaborate on end-to-end HCP core marketing strategy and own tactical execution for anzu-cel (IMA203)
• Define and execute prelaunch HCP marketing strategy to support the successful launch of anzu-cel
• Design and execute unbranded HLA testing awareness campaigns
• Develop HCP marketing materials in partnership with PRC and creative agencies
• Build KOLs relationship, lead ad boards, and ensure alignment
• Translate clinical trial data and scientific insights into HCP education and promotional materials
• Own congress strategy including booth design, messaging, and onsite presence
• Plan and execute digital media and non-personal promotion programs to expand reach into the community setting
• Partner with analytics and sales leadership to support account specific strategies and future field readiness
• Lead launch planning activities including positioning, sequencing, and execution readiness
• Define and track KPIs to guide optimization and investment decisions
• Manage agency partners, timelines, and budgets with disciplined prioritization
• Proactively identify risks, gaps, and opportunities and act with urgency
• Present confidently to internal and external audiences including senior leadership, KOLs, and partners

Director, Healthcare Professional

Director

• Lead market research and competitive intelligence initiatives to guide product strategy, portfolio prioritization, and business development.
• Develop and manage research plans (qualitative and quantitative) with emphasis on oncology & cell therapy markets.
• Continuously monitor the competitive landscape, providing timely insights on emerging therapies, clinical data, and market dynamics.
• Partner cross-functionally with Marketing, Sales, R&D, Clinical, and Corporate Development teams to align on strategic insights and implications.
• Present findings and strategic recommendations to executive leadership.
• Manage vendor relationships and budgets to ensure high-quality, data-driven deliverables.

Director, Market Research, Competitive Intelligence

Research Analyst

• Support clinical trial site feasibility and site selection process
• Conduct all aspects of clinical monitoring for clinical trials including conduct of site qualification visits, site initiation visits, routine monitoring visits and close-out visits at clinical trial sites
• Support the maintenance of the Investigator Site Files and sponsor Trial Master Files
• Conduct all aspects of site management as prescribed in the clinical trial specific functional plans
• Prepare accurate and timely trip visit reports
• Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiates appropriate actions to achieve objectives
• Organize and make presentations at Investigator Meetings
• Participate in the development of Case Report Forms and clinical trial documents
• Act as primary contact for clinical trial supplies and other suppliers (vendors)
• Participate in regular clinical trial team meetings
• Mentor less experienced or new CRA colleagues
• Perform CTM tasks as appropriate and as delegated by the CTM
• Proactively contributes to continuous improvement of Clinical Operation specific processes, procedure and templates

Senior Clinical Research Associate

• Establish and lead the Eastern region of MSLs, including recruitment, onboarding, and performance development.
• Manage a geographically dispersed team covering the Eastern half of the US, ensuring consistent, high-quality scientific engagement and field execution.
• Build a culture of scientific excellence, accountability, and collaboration aligned with Immatics’ mission.
• Ensure the team operates in compliance with internal SOPs, company standards, and regulatory requirements.
• Provide coaching, mentorship, and performance management to ensure MSL effectiveness and growth.
• Translate Medical Affairs objectives into clear field medical strategies that enhance scientific exchange, trial support, and data generation activities.
• Guide MSL engagement with investigators, opinion leaders, and treatment centers to support trial execution, insights capture, and regional education.
• Drive regional readiness and scientific fluency for launch and pipeline programs, ensuring alignment with overall US strategy.
• Oversee field medical coverage for national and regional congresses ensuring seamless pre-, on-site, and post-congress execution.
• Ensure external scientific interactions are conducted in a compliant and balanced manner.
• Drive regional execution of launch readiness for TCR T-cell therapy programs, including scientific education, stakeholder mapping, and insights integration.
• Partner with cross-functional teams to ensure consistent launch messaging and field preparedness.
• Contributes to early engagement and launch planning for future pipeline programs across solid tumors.
• Provide strategic oversight for Patient Advocacy, including trial awareness and education, sponsorship support, professional society collaboration, and executive-level advocacy engagement that strengthen Immatics’ partnerships with the patient community.
• Partner with the Medical Training & Content Senior Director to ensure MSLs are equipped with accurate, compliant, and effective field materials.
• Identify regional training needs, refine resources, and continuously strengthen field capabilities.
• Collaborate closely with the Executive Director, Medical Affairs (West) to ensure national alignment of field medical strategy, processes, and communication.
• Collaborate with other internal partners to align external engagement strategies and optimize impact.
• Establish processes for capturing and reporting actionable insights from KOLs, investigators, and treatment centers.
• Monitor team performance using KPIs, dashboards, and qualitative impact measures to assess field effectiveness.
• Translate regional insights into strategic recommendations that inform medical planning and decision-making.

Senior Director, Medical Communication and Training

QA Engineer

• Provide QA oversight for validation and revalidation activities of enterprise GxP systems (e.g. SAP, MES, LIMS) across the system development life cycle (SDLC)
• Ensure business processes are harmonized for inter-departmental digital system implementations
• Provide Insight and guidance for effective implementation of inter-departmental business processes related to quality control and manufacturing
• Provide validation strategies for complex systems in compliance with risk management and GAMP principles
• Review and approve validation deliverables, including User Requirements Specifications (URS), Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and Validation Summary Reports
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable FDA/EMA/ICH guidance
• Support implementation and qualification of new system functionalities, integrations, and upgrades under change control
• Oversee periodic review and system retirement/decommissioning activities to maintain validation status and data integrity
• Serve as QA approver for key validation and system lifecycle documents within global enterprise systems
• Ensure adherence to internal policies, procedures, and validation master plans
• Support development and continuous improvement of Computerized System Validation (CSV) and Computer Software Assurance (CSA) processes
• Partner with IT, Manufacturing, Quality Control, and Business Process Owners to ensure system compliance and readiness for inspection
• Mentor validation specialists and provide training on QA validation procedures and regulatory compliance
• Support needed within cross functional teams as CSV or QA role to help keep global application implementations on track