Address
Form of workJob Description
Reporting to the Vice President, CMC Regulatory, CARGO is seeking a Director, Technical Writingto build the technical (CMC) regulatory writing function for our cell-based gene therapy portfolio.
This person will be responsible for the development of US, EU, and rest of world Technical (CMC) regulatory submission documents in support of CARGO’s cell-based gene therapy pipeline. The individual must have deep knowledge of regulatory submission content requirements in major regions (US, EU). Reporting to the VP, CMC Regulatory, the successful candidate will work closely with colleagues in Regulatory, Quality, Technical Operations, and Translational Medicine as both the group leader and an individual contributor for the development of documents supporting IND, IMPD, MAA, BLA, briefing documents, and other regulatory submissions. This individual will also develop the infrastructure, processes and procedures needed for a successful technical (CMC) writing function.
The role is on site in San Carlos, CA.
WHAT YOU’LL DO AT CARGO THERAPEUTICS
- Develop and implement authoring, review and submission best practices and procedures
- Review technical reports as required by CMC function leaders in preparation for submission authoring
- Author, compile, and manage CMC sections for a wide variety of regulatory submissions including, but not limited to, IND, IMPD, QOS, Briefing Books, BLA and MAA
- Effectively communicate and manage the integrated document drafting and reviewing process following meeting filing timelines
- Collaborate effectively with Technical SMEs to prepare CMC sections of the regulatory dossiers
- Develop standardization of document templates and Company style guide to ensure quality and consistency across programs
- Ensure documents are well organized, accurate, consistent, and in compliance with applicable Company SOPs and style standards and local and national regulations
- Recruit, hire, and develop junior in-house writers; source, hire, and manage contract writers
- Interact closely with external vendors (e.g., publishers) to achieve on-time regulatory submissions
- Core contributor on global regulatory filings, to include INDs and BLA/MAA license applications
THE RIGHT STUFF: Required Experience & Qualifications
- Minimum of Bachelor’s degree in a scientific or engineering discipline with 10 years of pharmaceutical/biotechnology-related medical writing experience; advanced degree preferred
- Demonstrated superior scientific writing and analytical skills
- Direct medical writing experience supporting license applications (MAA/BLA, IND/IMPD) with focus on M2 and M3 of the CTD
- Advanced knowledge of FDA, EMA and ICH guidelines and regulatory requirements
- Extensive experience with eCTD development, publishing, and submission of regulatory documents
- Therapeutic experience in biologics is essential, with a strong preference for experience authoring cell-based gene therapy applications
- Strong planning and organizational skills with a history of prioritizing and multitasking multiple projects in a fast-paced environment utilizing excellent time management skills
- Adept at working autonomously, as well as collaboratively in a team
- Demonstrated leadership of direct-reports, contractors, and cross-functional teams
PAY RANGE
The combined pay range for this role is $184,000 - $253,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.
ABOUT CARGO THERAPEUTICS
CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic “cargo” designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO’s founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-tx.com/.
Join us to help make a difference!
EEO & EMPLOYMENT ELIGIBILITY
CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.
CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
