Director, Medical & Regulatory Writing

 

 

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.
• Evaluate appropriate technologies, automation, and artificial intelligence-enabled writing tools while maintaining scientific oversight, confidentiality, data integrity, and regulatory compliance.
• Perform other responsibilities based on business needs.

Required Qualifications & Experience

• Bachelor’s degree in a relevant scientific discipline, such as life sciences, biomedical sciences, or a related scientific field and a minimum 10 years of closely related experience. An advanced degree in a relevant scientific discipline preferred.
• Experience working in pharmaceutical, biotechnology, or contract research organizations; experience in both sponsor and CRO environments is advantageous; experience on the sponsor side required.
• Proven expertise in advanced medical and regulatory writing.
• Extensive knowledge of clinical development processes, clinical trial methodologies, regulatory submission requirements, and regulatory authority expectations.
• Must have strong knowledge of ICH M11 and principles of the Common Protocol Template (CPT).
• Experience with preparing global protocols and ICFs for studies in multiple regions (e.g. US, EU, UK, Japan)
• A successful track record of delivering high-quality medical and regulatory documentation within defined timelines and quality standards.
• Knowledge of regulatory guidelines and standards.
• Detail-oriented with excellent scientific judgment and ability to apply critical thinking to document preparation and review.
• Strong interpersonal, organizational, project management, and verbal and written communication skills.
• Advanced computer skills in Microsoft Office 365 programs.

Other Requirements

• Legally authorized to work for any employer in the U.S.
• Position is on-site in San Diego, CA

The job responsibilities and requirements provided above are intended to describe the general nature of the work performed by individuals assigned to this job classification. It is not intended to be an exhaustive list of all duties and requirements. Tr1X retains the right to add, change, or delete duties, education, experience or any other requirements of the position at any time.

Working at Tr1X

At Tr1X, our team is united by a singular shared mission: to transform patients’ lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and 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.