Director Clinical Regulatory Affairs (US)

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.The Director of Clinical and Regulatory Affairs (US) serves as the clinical regulatory lead for assigned programs within the cell and gene therapy portfolio at Immatics. This role owns and executes US clinical regulatory strategy, independently leading cross-functional efforts to advance development programs with precision, compliance, and speed. The Director anticipates regulatory risk, drives mitigation strategy, and operates as a trusted strategic partner to senior leadership. FLSA Classification: Salaried, Exempt Salary: $221,000 - $253,830Schedule: 8:00 AM - 5:00 PM; Monday to Friday; RemoteReports to: Senior Director, Regulatory Affairs Location: Remote or 13203 Murphy Road Suite 100 Stafford, TX 77477 What You'll Do: As Director of Clinical and Regulatory Affairs, you will: Develop, own, and continuously refine US clinical regulatory strategy aligned with global development plans and corporate objectivesServe as Regulatory Functional Lead for assigned US clinical programs, ensuring regulatory considerations are embedded in development decisionsLead 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 facilitationOversee and provide strategic direction for preparation and submission of INDs, amendments, annual reports, and future BLAs, ensuring scientific rigor and regulatory complianceProactively identify regulatory risks and design mitigation strategies; escalate critical strategic issues only after evaluation of proposed solutionsEnsure timely and high-quality responses to FDA requests for information and regulatory feedbackProvide program-level regulatory updates, strategic assessments, and recommendations to senior managementDrive cross-functional alignment across Clinical, CMC, Nonclinical, Regulatory Operations, and Commercial stakeholdersMonitor and assess regulatory landscape and evolving FDA guidance relevant to cell and gene therapy products; translate intelligence into strategic recommendationsEnsure regulatory timelines, deliverables, and submission milestones are achieved without need for day-to-day oversightContribute to development of departmental standards, best practices, and strategic regulatory frameworksModel and promote a solution-oriented mindset within cross-functional teamsSecondary Functions: Contribute to development and review of SOPs and policies related to Clinical Regulatory AffairsProvide mentorship and informal leadership to junior regulatory staff and matrix team membersSupport continuous improvement of regulatory processes and systemsRequired Experience and Education: Master's degree or higher in a scientific or similar discipline10+ years of regulatory affairs experienceDemonstrated experience independently leading FDA interactionsExperience developing regulatory strategy for complex clinical programsAbility to lead and execute self-sustainably with minimal supervisionStrong strategic thinking and risk assessment capabilitiesDemonstrated ability to influence cross-functional stakeholders without formal authorityPreferred Experience and Education: Advanced degree (PhD, PharmD, MD) preferredExperience in Cell & Gene Therapy or advanced therapeutic modalitiesExperience supporting BLA preparation or late-stage clinical developmentCompetencies Ability to lead and execute self-sustainably with minimal supervisionAbility to lead self and others; accountable for strategy and operational execution within area of responsibilityHigh strategic impact with enterprise-level thinkingStrong executive communication and presentation skillsProactive problem-solving and solution orientationAbility to anticipate regulatory challenges and drive innovative approachesAbility to act as deputy to A-level leadership for assigned programsWork Environment: This position works in a typical office environment with moderate noise levels and uses phone, computer, and office supplies regularly. Travel required: Limited travel required onsite to Immatics Houston, Immatics Germany, or meetings with external parties (health authorities, vendors, collaborators). 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.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. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. 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 - 7 days (56 hours)12 Paid Holidays100% Employer-Paid Life Insurance up to 1x annual salary100% Employer Paid Short- and Long-Term Disability Coverage401(k) with Immediate Eligibility & company match...Eligible for 401(k) plan participation as of your first paycheckThe 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 employmentPartially 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 InsuranceProfessional Growth: Opportunities to work with leading experts in the field of T-cell immunotherapy.Company provided learning and development opportunitiesFast paced, high demand, collaborative and dynamic environment.

Created: 2026-04-15