# Director, Medical & Regulatory Writing at Tr1X

> United States · Director+ · Other · open. Source: https://alderhq.app/jobs/greenhouse%3Atr1x%3A4720849006 (read 2026-11-12).

## Facts (observed)

- Company: [Tr1X](https://alderhq.app/companies/tr1x)
- Location text: San Diego, CA; San Diego, CA Corporate Headquarters
- Where it can be done from (inferred): United States (evidence: "Location: San Diego, CA; San Diego, CA Corporate Headquarters")
- Posted: 2026-10-12 (31 days ago)
- First seen by alder: 2026-11-07 · last verified: 2026-11-10
- Reposted: 0 times · edited: 0 times
- Apply on the employer's site: https://job-boards.greenhouse.io/tr1x/jobs/4720849006
- Skills listed (inferred): GCP

## Pay and sponsorship

- Posted pay: not posted
- Market band for similar posted roles (San Diego, n 45): p25 $176k, median $200k, p75 $247k

## Description (the employer's text)

### 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 strategy, content risks, submission readiness, resource constraints, and critical timelines.
- Establish medical writing standards, processes, governance frameworks, templates, and quality-control procedures across development programs.
- Drive continuous improvement initiatives to enhance document quality, operational efficiency, consistency, timeliness, and compliance.
- Ensure compliance with applicable regulatory requirements and guidance, including ICH guidelines, Good Clinical Practice (GCP), and relevant FDA regulatory expectations.
- Oversee implementation of quality assurance processes for medical writing deliverables, including content review, document QC, traceability, and controlled document management.
- Partner with Quality Assurance and Regulatory Affairs to support inspections, audits, submission readiness assessments, and corrective and preventive actions when required.
- Partner with senior leaders and cross-functional team members in Clinical Development, Clinical Operations, Translational Medicine, CMC, and Quality.
- Resolve complex content disagreements and drive timely decisions across multidisciplinary teams.

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Data: alder (https://alderhq.app). Cite https://alderhq.app/jobs/greenhouse%3Atr1x%3A4720849006 and the date you read it. Observed facts come from the employer's own listing; location reach, level, family and skills are inferences.