Immatics

• Lead the operational strategy and execution of Medical Affairs activities with strong business acumen. • Ensure that strategy is translated into coordinated, high-impact execution across cross-functional stakeholders. • Partner closely across internal teams and external stakeholders to ensure compliant, efficient, and scalable solutions that support medical strategy, launch readiness, and scientific exchange. • Translate Medical Affairs strategy into aligned goals and cross-functional plans spanning scientific engagement, communications, evidence generation, and launch readiness. • Enable alignment between US and Global strategies and drive clarity on priorities and execution. • Serve as trusted advisor to Medical Affairs Leadership by synthesizing complex clinical, scientific, and market insights into actional recommendations.

• Conduct all clinical monitoring activities, including site qualification, initiation, routine monitoring, and close-out visits • Support site feasibility, site selection, and ongoing site management activities throughout the clinical trial lifecycle • Review clinical trial progress, patient recruitment, and data quality metrics, and implement actions to support study objectives • Maintain accurate and timely monitoring documentation, including trip reports and trial master file records • Collaborate with vendors, clinical sites, and cross-functional teams to support study execution and operational compliance • Participate in investigator meetings, clinical trial documentation development, and study team meetings • Mentor junior CRA team members and contribute to continuous improvement of clinical operations processes and procedures

• 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

• Oversee site management, monitoring oversight, and clinical trial operations activities to ensure compliance with GCP, regulatory requirements, and company SOPs • Work closely with cross-functional teams and clinical sites to drive study execution, site engagement, and operational excellence across clinical trials • Lead site feasibility, selection, initiation, and greenlight activities for clinical trial sites • Develop and maintain study-specific operational plans, training materials, and monitoring documentation • Review trial progress, patient recruitment, and data quality metrics, and implement actions to support study objectives

• Lead global clinical trial execution and operational delivery across internal and external stakeholders • Provide oversight of CROs, vendors, and clinical trial partners to ensure quality, compliance, timelines, and budget objectives are achieved • Drive risk identification, issue escalation, and mitigation planning across assigned studies • Support study start up, site feasibility, enrollment, and operational execution activities • Partner cross-functionally with Clinical Development, Regulatory, Safety, Biometrics, Supply Chain, and external vendors • Contribute to SOP development, process optimization, inspection readiness, and operational excellence initiatives • Mentor junior Clinical Operations team members as applicable

• Ensure clinical trial site management and monitoring activities in compliance with GCP guidelines, applicable regulations, and SOPs • Execute clinical monitoring activities, including qualification, initiation, routine monitoring, and close-out visits • Maintain Investigator Site Files and Trial Master Files • Implement site management activities in line with trial-specific functional plans • Prepare accurate and timely visit reports • Review trial progress (e.g., patient recruitment, data capture, issue resolution) and initiate appropriate actions • Serve as primary contact for clinical trial supplies and other stakeholders or vendors • Participate in clinical trial team, department and company meetings • Contribute to the development of trial specific documents • Contribute to the continuous improvement of Clinical Operations processes and procedures

• 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.

• 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

Title: Senior Clinical Research Associate Location: Remote Work (USA) time type Full time job requisition id JR100687 Join Immatics and shape the future of cancer immunotherapy; one patient at a time! Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. Why Join Us? - Innovative Environment: Help to pioneer advancements in cancer immunotherapy. - Collaborative Culture: Be part of a diverse team dedicated to your professional growth. - Global Impact: Contribute to therapies that make a lasting impact on patients globally. Role Overview: We are seeking a Senior Clinical Research Associate (CRA) to support our Clinical Operations team. The Senior CRA will be responsible for overseeing clinical trial site management and monitoring activities to ensure compliance with ICH-GCP, regulatory requirements, and company SOPs. In this role, you will partner closely with clinical sites and cross-functional teams to support high-quality study execution, patient recruitment, and operational excellence across clinical trials.   Reports to: Associate Director, Team Lead Site Operations Location: Fully Remote Salary Range: $120,000 to $135,000 Basic Qualifications: - Bachelor’s degree in life sciences, nursing, or a related field - 4+ years of on-site monitoring experience within the pharmaceutical or biotechnology industry, including all clinical monitoring visit types - Strong knowledge of ICH-GCP, FDA, EMA, and applicable clinical trial regulations - Demonstrated experience managing clinical trial sites, monitoring activities, and clinical trial documentation - Proficiency with clinical trial systems and tools (e.g., CTMS, eTMF, Microsoft Office) Preferred Qualifications: - Experience in oncology clinical trials or related therapeutic areas - Advanced presentation, organizational, and stakeholder management skills - Experience mentoring or training junior CRAs and supporting cross-functional clinical operations activities - Demonstrated ability to drive quality, efficiency, and continuous improvement initiatives in clinical operations - Strong understanding of clinical trial recruitment strategies, data capture, and site engagement best practices - Experience contributing to global harmonization, process optimization, or operational innovation initiatives In this role you will: - Conduct all clinical monitoring activities, including site qualification, initiation, routine monitoring, and close-out visits - Support site feasibility, site selection, and ongoing site management activities throughout the clinical trial lifecycle - Review clinical trial progress, patient recruitment, and data quality metrics, and implement actions to support study objectives - Maintain accurate and timely monitoring documentation, including trip reports and trial master file records - Collaborate with vendors, clinical sites, and cross-functional teams to support study execution and operational compliance - Participate in investigator meetings, clinical trial documentation development, and study team meetings - Mentor junior CRA team members and contribute to continuous improvement of clinical operations processes and procedures Travel required: Willingness to travel up to 75%. Valid Driver's License preferable. Qualified candidates will participate in a structured interview process, which includes: - An initial recruiter phone screen (conducted via video) - A recruiter-facilitated introduction and interview with the hiring leader and key stakeholders (via video) - A final-stage interview, which may include an in-person meeting at our U.S. Headquarters in Houston, TX What do we offer?  At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join Immatics   Comprehensive Benefits:  - Competitive rates for Health, Dental, and Vision Insurance - 4 weeks of vacation, granted up front each year and prorated for first and last year of employment. - 12 company paid holidays - 7 days of sick time - 100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars - 100% employer-paid short- and long-Term disability coverage  - 401(k) with immediate eligibility and company match… - The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. - Partially paid parental leave for eligible employees. - Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance. Equal Employment Opportunity  We are an equal opportunity employer and are committed to building a diverse and inclusive workplace.  We consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, marital status, disability, genetic information, veteran status, or any other status protected by applicable law.    Work Authorization  Applicants must be authorized to work in the United States without the need for current or future sponsorship.  Visa sponsorships may be available for certain roles.    Pre-Employment Requirements  Employment is contingent upon successful completion of a background check, reference checks and pre-employment drug screening, where permitted by applicable law.  For certain roles, additional screenings such as a credit check or motor vehicle record review may be required, where job-related and consistent with business necessity.

• Serve as the EU Submission Lead for assigned clinical trials • Act as primary contact for submission planning and execution • Lead the preparation and submission of initial applications and amendments via CTIS • Ensure compliance with regulatory requirements • Drive submission readiness and oversee regulatory filing readiness • Coordinate the preparation and submission of timely Request for Information responses