Director, Medical & Regulatory Writing

The posting, as Tr1X wrote it

About Tr1X

Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc. is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit www.tr1x.bio.

Position Summary

The Director, Medical and Regulatory Writing reports to the Vice President, Head of Regulatory Affairs and provides strategic planning, development, review, and delivery of high-quality medical, clinical, and regulatory documentation supporting Tr1X clinical programs. The role is responsible for establishing and executing medical writing strategies across clinical development programs, ensuring the timely preparation of scientifically accurate, regulatory-compliant documentation. The Director drives document quality and operational excellence and collaborates with senior leaders across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, CMC/Technical Operations, and other functions.

The position plays a critical role in supporting regulatory milestones and submissions throughout the product lifecycle, while ensuring alignment with applicable regulatory requirements, scientific standards, and corporate objectives.

Key Responsibilities

• Partner with Regulatory to develop and implement the medical writing strategy in alignment with corporate objectives, clinical development plans, regulatory strategies, and program goals.
• Author (writes & edits) high-quality documents across all program areas as needed such as clinical study protocols, protocol amendments, ICFs, clinical study reports, DSURs, Investigator’s Brochures, as well as more complex documents, e.g., INDs, NDAs, briefing packages, etc.
• Prepare and perform a quality review of clinical study protocols, protocol amendments, clinical study reports, investigator brochures, clinical summaries, and other essential clinical development documents.
• Lead, manage, and coordinate process for preparation of documents. This includes leading adjudication meetings to align on scope and to resolve comments, as well as driving timelines and interacting with Regulatory to coordinate final delivery for publishing.
• Ensure scientific conclusions are evidence-based, appropriately supported by clinical data, and consistent across the clinical and regulatory documentation portfolio.
• Establish standards for document consistency, reference verification, data presentation, medical terminology, and scientific interpretation.
• Advise leadership and cross-functional teams on document strate

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empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured.

Base Pay Range Anticipated: $200,000 - $220,000

Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position.

Compensation and Benefits

Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays.

Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at careers@tr1x.bio.

Notice to Employment Agencies

The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.