Director Clinical Regulatory Affairs (US)

Immatics•Houston, TX

13d•$221,000 - $253,830•Remote

About The Position

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

Requirements

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
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
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.
Legal eligibility to work in the United States is required.

Nice To Haves

Advanced degree (PhD, PharmD, MD) preferred
Experience in Cell & Gene Therapy or advanced therapeutic modalities
Experience supporting BLA preparation or late-stage clinical development

Responsibilities

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
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

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