Sr. Director, Head of Regulatory & Medical Writing

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary: As a key member of the cross-functional Development Team responsible for providing regulatory writing expertise and leadership to formulate the writing strategy for key regulatory documents for submission. The Sr. ; will also provide review and substantive editing of documents to ensure delivery of high-quality documents.

This individual will work effectively with many other functional groups, including with Clinical Scientist(s), Medical Monitors, Regulatory and other functions as applicable, and collaborate with clinical medical writing as applicable to ensure scientific excellence in the execution of clinical trials. The Head of Regulatory Writing will build a medical writing group internally when appropriate. Reporting to the SVP, Head of Regulatory Affairs, this role will be responsible for the regulatory writing & medical writing deliverables of assigned project(s), in accordance with the agreed timelines and quality standards.

Responsibilities

: Ensure appropriate allocation of internal and external resources needed for all regulatory writing deliverables. Hire and manage medical writers internally and manage external medical writing contractors. Forecasting and maintaining budget for the regulatory writing team.

Assess efficiencies, help identify areas of improvement and initiate improvement processes. Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to: Clinical study protocols and clinical protocol amendments (in partnership with Clinical Science/Clinical Development) Clinical study reports Investigator’s brochures and annual updates IND submissions and annual reports Lay-person summary Integrated summary reports Clinical, Nonclinical and Multidisciplinary Information Amendments NDA, BLA, MAA, (e)CTD submissions Risk Management Plans Health Authority responses Briefing Documents, ODDs, BTDs/PRIME, FTD etc Participate in relevant subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across all projects. Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.

Requirements

Partner with Biometrics in developing standard TFLs and in text tables for deliverables as applicable Maintain and support developing and reviewing standard processes and templates. Review and edit documents as required. Work effectively and lead in cross-functional working groups.

Qualifications

: Candidates must have a BS with 15+ years, or MS or other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of experience in oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biot