
Immatics
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Delivering the Power of T Cells to Cancer Patients
17 Jobs
Senior Manager, Regulatory Affairs – Submission Lead
ImmaticsDelivering the Power of T Cells to Cancer Patients
• 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
• Ensure and support GCP-compliant planning and execution of clinical studies • Oversee GCP-compliant monitoring of outsourced Clinical Operations activities • Contribute to the selection and qualification of GCP/GCLP vendors • Lead project reviews and manage processes • Provide operational support to central laboratories • Perform administrative clinical trial tasks
Role Description We are seeking a Clinical Trial Manager (CTM) to support our U.S. Clinical Operations team. The CTM will oversee site management, monitoring oversight, and clinical trial operations activities to ensure compliance with GCP, regulatory requirements, and company SOPs. In this role, you will work closely with cross-functional teams and clinical sites to drive study execution, site engagement, and operational excellence across clinical trials. Reports to: Associate Director, Team Lead Site Operations Location: Fully Remote Salary Range: $130,000 - $150,000 Qualifications - Bachelor’s degree in life sciences, nursing, or a related field - 2+ years of experience in on-site clinical monitoring - 2+ years of Clinical Trial Manager experience within the pharmaceutical or biotechnology industry - Strong knowledge of ICH-GCP, FDA, EMA, and applicable clinical trial regulations - Demonstrated experience managing clinical trial sites, monitoring activities, and regulatory documentation - Proficiency with clinical trial systems and tools (e.g., CTMS, eTMF, Microsoft Office) Requirements - Experience in oncology clinical trials or related therapeutic areas - Advanced ability to manage complex clinical operations processes and drive operational improvements - Experience leading training initiatives for CRAs and clinical trial sites - Demonstrated ability to drive quality, efficiency, and milestone achievement in fast-paced clinical environments - Experience contributing to process harmonization, innovation, and continuous improvement initiatives - Strong presentation, organizational, and cross-functional stakeholder management skills Responsibilities - Partner with Clinical Operations leadership to support clinical trial execution and monitoring activities in alignment with project goals - Lead site feasibility, selection, initiation, and greenlight activities for clinical trial sites - Develop and maintain study-specific operational plans, training materials, and monitoring documentation - Oversee site management activities, including site engagement, regulatory submissions, and monitoring oversight - Review trial progress, patient recruitment, and data quality metrics, and implement actions to support study objectives - Provide guidance and oversight to CRAs, including trip report review and training support - Manage protocol and GCP deviations and contribute to continuous improvement of clinical operations processes and procedures Travel Requirements Travel required: up to 50% travel required, domestically and internationally. Interview Process 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 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 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 - 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. Reasonable Accommodations We are committed to providing reasonable accommodations to individuals with disabilities and to applicants with sincerely held religious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contact us at RecruitingUS@immatics.com.
• Play a critical leadership role in shaping and executing our U.S. market access strategy with national and regional payers (commercial and government) in preparation for our first cell therapy launch. • Responsible for building relationships with key payer stakeholders, communicating product value and disease state unmet need, and ultimately securing favorable coverage and reimbursement pathways. • Lead strategic engagement with national and large regional payers in both the commercial and government segments. • Build and manage relationships with key decision-makers across payer organizations, including key pharmacy and medical stakeholders. • 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. • Partner with internal teams 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. • Ensure all engagements and materials are fully compliant with legal, regulatory, and corporate standards.
• Support the execution of our clinical trials, including the SUPRAME (IMA203-301) study. • Responsible for supporting patient journey navigation, primarily for U.S. sites. • Update patient-facing and clinical trial materials. • Contribute to protocol development. • Conduct literature research. • Support trial outcome reporting. • Deliver training to internal and external stakeholders. • Serve as a key point of contact for clinical trial protocol and patient-facing material inquiries from sites and internal teams. • Support patient journey navigation, including proactive management of screening activities. • Contribute to authoring and updating clinical trial documents, including protocols, reports, and investigator materials. • Support preparation of responses for IRBs and regulatory authorities. • Deliver site training on clinical trial protocols and patient-facing materials (e.g., SIVs). • Maintain accurate eTMF documentation and filing. • Travel required: up to 20% travel required , domestically and internationally.
• Lead site touchpoint calls, document key updates, and coordinate next steps to support timely patient progression and randomization • Align cross-functionally with internal stakeholders to ensure consistent, accurate guidance is provided to sites • Manage and adapt patient journeys in real time based on individual needs and site constraints, following the defined V2V pathway • Drive end-to-end patient workflows to achieve rapid, compliant progression pre- and post-randomization • Coordinate key milestones including eligibility, randomization, and manufacturing timelines with internal teams • Provide sites with clear guidance on required EDC completion and support issue resolution, including out-of-specifications communication • Serve as a responsive, reliable point of contact for site stakeholders, including availability outside standard hours
Role Description We are seeking a Senior Manager Regulatory Affairs to strengthen our Regulatory Affairs department. In this role, you will lead and further develop our Regulatory Intelligence capabilities, helping translate emerging global regulatory developments into actionable insights for Regulatory Affairs and cross-functional stakeholders. In addition, you will provide targeted support to development programs, including CTA-related clinical and/or CMC documentation. You will work in Tübingen, Munich, or remote within Germany in an interdisciplinary environment with colleagues across Germany and the US, contributing to our mission of delivering novel PRAME immunotherapies to patients with cancer. This position is a fixed-term role of 18 months as it covers a maternity leave. Your responsibilities will include but are not limited to: - Lead the development, optimization and continuous improvement of Regulatory Intelligence tools and processes - Proactively monitor, assess and interpret emerging global regulatory developments, guidelines, and relevant competitive intelligence - Translate Regulatory Intelligence information into clear, actionable insights that support our regulatory strategy and cross-functional decision-making - Drive the review, synthesis and dissemination of regulatory intelligence within Regulatory Affairs and to relevant stakeholders - Oversee and coordinate the structured documentation, tracking and maintenance of Regulatory Intelligence information within internal systems - Provide regulatory support for Immatics development programs, including preparation, review and contribution to documentation for CTA applications and subsequent modifications, with a focus on clinical and/or CMC aspects - Help ensure that regulatory documentation meets applicable requirements, guidelines, and quality standards Qualifications - Master’s degree in Life Sciences, Healthcare, or a related discipline; a Master’s degree in Regulatory Affairs is a plus - 5+ years of experience in Regulatory Affairs within the biopharmaceutical industry; experience in Regulatory Intelligence and/or development Regulatory Affairs - Experience with biologics and/or ATMPs is strongly preferred - Strong analytical mindset with the ability to interpret complex regulatory environments and translate insights into strategy - Proven ability to work independently while effectively collaborating in cross-functional and international teams - Highly organized, proactive, and adaptable, with a forward-thinking and solution-oriented approach - Excellent stakeholder engagement and communication skills in English (C1 or higher); German is advantageous Benefits - Job bike - Job ticket - Health Programs - Childcare benefits - Relocation allowance - Company summer and winter events Company Description 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.
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. We are seeking a Clinical Trial Associate II to support our US Clinical Operations team. The Clinical Trial Associate II will be responsible for Providing support for the GCP compliant clinical trial planning, conduct and oversight of clinical trials. FLSA Classification: Salary, Exempt Schedule: 8:00 AM – 5:00 PM; Monday to Friday Reports to: Associate Director, Team Lead Trial Management Location: Remote Salary Range: $80,000 - $100,000 What You’ll Do: Main responsibilities of this position include but are not limited to the following tasks: - Keeping oversight, incl. but not limited to: - tracking tools set-up and maintenance - report preparation - clinical trial documents preparation, performing review and/ or quality control - Providing support to the administration of clinical trials, incl. but not limited to: - meeting organization - preparation of meeting minutes - coordinating review processes and signature rounds - printing / arranging printing service - preparation of the Investigator Site File template - Organization of investigator grant payments and oversight of investigator grant payments - Development and maintenance of SOPs, guidance documents & training material - Minimal supervision required for routine tasks Required Experience and Education: - Bachelor's degree in a life science/medical field or equivalent experience - 2+ years working experience in the clinical research area in the pharmaceutical/biotech industry with ICH-GCP knowledge - Proactive contribution to development of team structure and processes - Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS). - Team-oriented and a strong team player - Ability to identify, analyze and communicate problems and suitable solutions - Independent, accurate and attention to detail working style - Good understanding of priorities within own scope, prioritization requires limited interaction with supervisor - High degree of initiative and intrinsic motivation to exceed basic expectations for own tasks and responsibilities Competencies - Intermediate organizational skills to structure own tasks and predefined working packages - Ability of need and room for improvement within own scope - Initiative - Problem Solving - Critical Thinking - Interpersonal Communication - Customer Service - Attention to Detail Work Environment: This is a sedentary position (at least 50% of time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs is expected. 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 Travel Requirement: less than 10%. Physical demands: - Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. - Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. - Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others. - Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder. - Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers). - Pushing - Exerting force upon an object so that the object moves away from the object. - Pulling - Exerting force upon an object so that the object moves toward the force. - Sitting – remaining in a sitting position for at least 50% of the time. - Standing/Walking - remain on one's feet in an upright position at a workstation. - Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles. Work authorization/security clearance requirements: Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment Affirmative Action/EEO statement: Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. 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 Paid Time off, granted up front each year and prorated for first and last year of employment. - Sick Time Off – 7 days - 12 Paid Holidays - 100% Employer-Paid Life Insurance up to at 1x annual salary - 100% Employer Paid Short- and Long-Term Disability Coverage - 401(k) with Immediate Eligibility & company match… - You are eligible for 401(k) plan participation as of your first paycheck. - 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. (3 weeks) - Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance. Professional Growth: - Opportunities to work with leading experts in the field of T-cell immunotherapy. - Company provided learning and development opportunities - Fast paced, high demand collaborative and dynamic environment.
• Lead the Global Publication Planning Team cadence (agendas, decisions, timelines, action tracking) and execute the rolling 12–24 month publication plan. • Drive end-to-end delivery of peer-reviewed and congress outputs (abstracts, manuscripts, posters, oral presentations), including author coordination and internal review cycles. • Define and maintain a global congress and publication disclosure calendar (12–24 months) that integrates analysis readiness, internal governance milestones, and external submission deadlines. • Own author/KOL strategy for priority publications (target journals/congress slots, authorship planning, competitive differentiation, and submission positioning) • Lead congress strategy and readiness for priority meetings (e.g., ASCO/ESMO/SITC/SMR/SGO), including narrative strategy, data packages, internal review governance, and post-congress dissemination planning • Execute high-priority anzu-cel market preparation tactics, including manuscripts and congress packages that support clinical practice adoption, competitive differentiation, and launch readiness • Lead publication tactics involving complex analyses (secondary/tertiary/post hoc exploratory) and/or nontraditional datasets (e.g., compassionate use case studies, collaborative translational analyses with academia, and patient-authored manuscripts where appropriate) • Partner with cross-functional teams to translate evidence into medical education and scientific enablement needs (e.g., narrative modules, FAQs, scientific decks) that stand up to peer review and KOL scrutiny, maintain clear separation from promotional content, and adhere to compliance guardrails • Develop, maintain, and operationalize the Scientific Platform & Lexicon for anzu-cel and priority programs (core scientific narrative, terminology standards, claims language, data interpretation guardrails, data tables, and approved phrasing) • Ensure consistent scientific language and message discipline across publications, congress assets, advisory board materials, and insight outputs • Lead day-to-day Medical Communications vendor execution: scopes of work, resourcing plans, quality standards, timelines, and performance scorecards/quarterly business reviews • Build scalable processes (templates, checklists, SOPs) that improve quality, compliance, and cycle time.
• Lead end-to-end recruitment processes across assigned functions • Develop and execute targeted sourcing strategies utilizing direct sourcing, networking, industry research, and talent pipeline development • Manage hard-to-fill requisitions with a proactive, research driven sourcing methodology which may include partnering with external search partners • Ensure a high-quality candidate experience aligned with Immatics’ values and employer brand. • Oversee requisition management and reporting within Workday Applicant Tracking System (ATS) • Optimize workflows, data integrity, and recruiting metrics (time-to-fill, quality of hire, offer acceptance rate, etc.) • Drive continuous improvement in TA processes, tools, and systems. • Establish and maintain structured interview processes to improve hiring quality, reduce bias, and enhance decision-making. • Ensure compliance with applicable employment laws and pay transparency requirements. • Partner with HR and Compensation teams on offer strategy, competitive benchmarking, and negotiation for critical hires. • Manage relationships with external search firms, recruiting vendors, temporary agencies, and talent platforms to ensure optimal sourcing strategies and cost effectiveness. • Partner with HR and Communications to strengthen Immatics’ employer brand, ensuring consistent messaging across talent attraction channels and positioning the organization competitively within the biopharmaceutical talent market. • Support organizational growth in both start-up and post-FDA approval environments • Build scalable hiring frameworks to support rapid headcount growth • Provide day-to-day guidance, mentorship, and subject-matter expertise to members of the Talent Acquisition team, supporting development of recruiting capabilities and best practices. • Serve as a trusted advisor and strategic partner to senior leaders and hiring managers, coaching on role definition, interview best practices, selection methodology, and inclusive hiring. • Partner cross-functionally to align talent acquisition considerations into business planning, growth initiatives, and organizational design discussions. • Leverage Workday ATS to manage requisitions, maintain data integrity, track recruiting metrics, and optimize hiring workflows. • Drive continuous process improvement, scalability, and operational excellence within the Talent Acquisition function.
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