Director Clinical Regulatory Affairs (US)

Immatics•Houston, TX

4d•Remote

About The Position

J oin Immatics and s hape the f uture of c ancer i mmunotherapy ; 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 patient s globally . The Director of Clinical and Regulatory Affairs (US) serves as the clinical regulatory lead for assigned programs within t he cell and gen e therapy portfolio at Imma tics . This role owns and executes US clinical regulatory strategy, independently leading cross-functional efforts to advance development programs with precision, compliance , and speed. The Direc tor anticip ates regulatory risk, drives mitigation strategy, and oper ates as a trusted strategic partner to senior leadership.

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

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 P aid Time O ff, 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 mat ch… E ligible 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 employmen t , 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment
P artially 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
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.