Director Clinical Regulatory Affairs (US) at Immatics

Houston, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

23 May, 26

Salary

253830.0

Posted On

22 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Regulatory Strategy, Regulatory Affairs, FDA Interactions, IND Submissions, BLA Preparation, Risk Mitigation, Cross-Functional Leadership, Cell Therapy, Gene Therapy, Regulatory Compliance, Strategic Thinking, Risk Assessment, Executive Communication, Problem-Solving, Regulatory Guidance Monitoring, Program Management

Industry

Biotechnology Research

Description

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 - $253,830 Schedule: 8:00 AM – 5:00 PM; Monday to Friday; Remote Reports 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 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 Secondary Functions: Contribute to development and review of SOPs and policies related to Clinical Regulatory Affairs Provide mentorship and informal leadership to junior regulatory staff and matrix team members Support continuous improvement of regulatory processes and systems Required Experience and Education: Master’s degree or higher in a scientific or similar discipline 10+ years of regulatory affairs experience Demonstrated experience independently leading FDA interactions Experience developing regulatory strategy for complex clinical programs Ability to lead and execute self-sustainably with minimal supervision Strong strategic thinking and risk assessment capabilities Demonstrated ability to influence cross-functional stakeholders without formal authority Preferred Experience and Education: Advanced degree (PhD, PharmD, MD) preferred Experience in Cell & Gene Therapy or advanced therapeutic modalities Experience supporting BLA preparation or late-stage clinical development Competencies Ability to lead and execute self-sustainably with minimal supervision Ability to lead self and others; accountable for strategy and operational execution within area of responsibility High strategic impact with enterprise-level thinking Strong executive communication and presentation skills Proactive problem-solving and solution orientation Ability to anticipate regulatory challenges and drive innovative approaches Ability to act as deputy to A-level leadership for assigned programs Work 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. 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. 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 Holidays 100% Employer-Paid Life Insurance up to 1x annual salary 100% Employer Paid Short- and Long-Term Disability Coverage 401(k) with Immediate Eligibility & company match… 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. Please apply using your FULL LEGAL FIRST AND LAST NAME as displayed on your government identification. 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. We are only accepting digital applications via the application form of each position. For general inquiries on recruiting topics, please write a message to RecruitingGer@immatics.com for German recruiting topics or RecruitingUS@immatics.com for US recruiting topics.

Responsibilities

The Director serves as the clinical regulatory lead for assigned cell and gene therapy programs, owning and executing the US clinical regulatory strategy while leading cross-functional efforts for development advancement. This role involves leading FDA interactions, overseeing IND/BLA submissions, proactively identifying regulatory risks, and providing strategic recommendations to senior leadership.