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. Director, Head of Regulatory & Medical Writing will be responsible for providing guidance to the medical and or regulatory writing group (contractors and internal writers) assigned to deliverables and ensuring appropriate work allocation and document preparation.; 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.
• Support and develop deliverables required for global transparency and disclosure requirements (e.g., plain language lay summary, applicable redactions to regulatory documents subject to EU posting regulations and results for EU CTR).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/biotech industry.
• Prior experience leading a regulatory writing group
• Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
• Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, document management systems.
• Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures and clinical study data collection and results reporting.
• Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Experience writing, at a minimum, protocols (Phase 1-3, in oncology), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred.
• Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize complex tabular and graphical data presentations.
• Strong organization, documentation and communication skills with an ability to multitask.
• Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Position Summary:

The Associate Director, GxP Systems will report to the Sr. Director, Commercialization Systems and will be responsible for leading the implementation, validation, and support of GxP-regulated systems to enable Quality Assurance, Regulatory, Clinical, and Process Development & Manufacturing (PD&M) in a commercial biotech environment. This role will play a pivotal part in supporting regulatory, compliance, and for commercialization. Working with Quality Assurance, Medical Affairs, Regulatory Affairs, Clinical Operations, and PD&M functions to ensure systems are fit-for-purpose, validated and aligned with evolving business requirements.

Responsibilities:

• Serve as the System Owner and hands-on administrator for GxP systems (e.g., TraceLink, Lorenz DocuBridge, Egnyte Life Sciences, ZenQMS, Global Vision, Veeva), overseeing system lifecycle, performance, and compliance
• Participate in system implementation activities, including vendor selection, requirements gathering, testing, and deployment to ensure alignment with business and regulatory needs
• Provide oversight and direction for Computer System Validation (CSV) activities and validation documentation, partnering with the Validation Engineer to ensure regulatory compliance and audit readiness
• Own and lead Change Control processes for all GxP systems, including impact assessments, risk evaluations, documentation, coordination of testing, and release management
• Perform system administration activities, including user access provisioning, role management, periodic access reviews, and audit trail monitoring
• Oversee system maintenance, enhancements, and issue resolution (e.g., upgrades, patches, changes), ensuring appropriate validation impact assessments, documentation updates, and minimal business disruption
• Collaborate with IT and vendors to support integration, system performance optimization, and resolution of technical issues
• Develop and maintain system-related documentation, including SOPs, Systems Inventory, administrative procedures, and work instructions in collaboration with Quality Assurance and business stakeholders
• Provide SME support during FDA audits and inspections, including preparation, documentation review, and representation of system controls and validation status
• Drive continuous improvement by identifying gaps, inefficiencies, and opportunities for system scalability and automation
• Translate business requirements into effective system solutions, acting as a key liaison between business stakeholders and technical teams
• Manage project timelines, risks, and deliverables to ensure successful and compliant execution of system initiatives

Qualifications:

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related field; advanced degree preferred
• 10-12 years of hands-on experience with GxP systems in Life Sciences, including system administration, validation oversight, and operational support
• Proven experience implementing and validating systems such as eQMS, TraceLink, LMS, Validated Documents and Data storage solutions (such as Box for GxP or Egnyte Life Sciences), or ERP systems (e.g., NetSuite, Oracle, SAP) in a GxP-regulated environment
• Strong understanding of CSV, data integrity, Part 11 compliance, and regulatory expectations (FDA, EMA, ICH)
• Experience partnering with validation/CSV resources while maintaining accountability for system compliance and validation outcomes
• Proven experience owning and managing Change Control processes for GxP systems
• Experience supporting pre-commercial biotech organizations transitioning to commercialization
• Ability to balance strategic oversight with hands-on system administration and operational responsibilities
• Strong cross-functional collaboration skills across IT, QA, Regulatory, and Technical Operations
• Experience managing vendors and implementation partners
• Excellent troubleshooting, analytical, and problem-solving skills
• Strong communication skills with the ability to translate technical concepts into business terms and influence stakeholders

Position Summary:

The Vice President, Regulatory Affairs will be responsible for the development and execution of the company’s Regulatory strategy and report into the Senior Vice President, Regulatory and Quality.  This critical hire will provide input, prioritize, implement, monitor, and communicate Vera’s Regulatory strategy and programs.  As part of the Quality and Regulatory leadership team, you will establish and translate Vera’s Regulatory strategy into operational policies, processes, procedures, and training to meet global regulatory, medical/health, and legislative standards.  This role requires experience, knowledge, and leadership credibility to be effective across Vera in multiple capacities, thereby ensuring compliance with Regulatory standards and corporate-wide commitment to Quality principles and Vera values.

Responsibilities:

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• In this highly visible role, the successful candidate will develop and lead integrated global regulatory strategies (US, EU, and key ex‑US markets) for all pipeline programs, aligning with overall corporate and clinical development goals.
• Serve as a primary regulatory strategist providing clear assessments of regulatory options, risks, and timelines to inform portfolio and investment decisions.
• Oversee planning, authoring, review, and submission of regulatory dossiers including pre‑IND/IMPD packages, INDs/CTAs, IBs, pediatric plans, orphan/expedited program requests, DSURs/PSURs, NDAs/BLAs/MAAs, and post‑approval supplements/variations.
• Lead or directly oversee global health authority interactions (e.g., FDA, EMA, PMDA and key national agencies), including scientific advice/protocol assistance, Type B/C meetings, pre-submission and advisory committee preparations; ensure high‑quality briefing packages and robust meeting follow‑up.
• Partner closely with cross-functional teams to ensure clinical trial designs, endpoints, and statistical plans are aligned with regulatory expectations and support future registration.
• Oversee global CMC regulatory strategies, including module 3/quality sections, comparability plans, and lifecycle management; ensure alignment with GxP and ICH requirements.
• Ensure timely, accurate maintenance of all active INDs/CTAs and marketing authorizations, including safety reports, annual reports, labeling updates, and other commitments.
• Build, lead, and mentor a high‑performing regulatory team effectively leveraging external consultants, CROs, and vendors for eCTD publishing and ex‑US submissions.
• Establish and continuously improve phase‑appropriate regulatory processes, standards, and governance (e.g., submission planning, HA interaction tracking, labeling governance) suitable for a lean organization.
• Stay current on evolving global regulatory requirements, guidance, and precedent, and proactively incorporate learnings into program strategies and company policies.
• Support business development activities by contributing regulatory due diligence, risk/benefit assessments, and integration planning for potential partnerships, in‑licensing, and acquisitions.
• Represent Regulatory Affairs on cross‑functional governance bodies and, as needed, with partners, and external stakeholders.

Qualifications:

• Advanced degree in life sciences or related discipline (e.g., PhD, PharmD, MD, or MS); equivalent experience may be considered.
• 15+ years of increasing responsibility in biopharmaceutical regulatory affairs, including substantial experience in small or mid‑size biotech environments.
• Proven track record of leading major global submissions (IND/CTA and NDA/BLA/MAA or equivalent) through acceptance and, ideally, approval.
• Demonstrated experience interacting directly with FDA, EMA and other global health authorities, including leading meetings and negotiations on complex issues.
• Strong understanding of global regulatory frameworks (ICH, FDA, EMA and other regional requirements) across early development, registration, and post‑approval lifecycle management.
• Experience overseeing or partnering with CMC, regulatory operations/electronic submissions (eCTD), and safety/periodic reporting activities.
• Demonstrated ability to build, lead, and develop teams, and to work effectively as both a hands‑on individual contributor and strategic leader in a lean, fast‑paced biotech setting.
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly to both technical and non‑technical audiences, including senior leadership and external partners.
• High degree of integrity, sound judgment, and a pragmatic, solutions‑oriented mindset with strong organizational and project management skills.

About this opportunity:

At Freenome, we are seeking a Technical Product Manager to join the Freenome Product Management team. This role will be responsible for planning and coordinating the execution of Freenome’s engineering initiatives for the Commercial Data Platform and Data Products. You will create, plan and execute software development plans while ensuring efficiency, scalability and usability for our Commercial, Laboratory, and R&D teams. You will gather requirements and prioritize technical development in alignment with cross-functional teams and stakeholders.

This role will lead discussions with key-decision makers and stakeholders to create a comprehensive data platform roadmap outlining Freenome’s path to commercialization and support for ongoing product development. You will work closely with our engineering team, leveraging your deep knowledge in Agile methodologies (Scrum, Kanban, sprint planning, etc) to enable seamless execution. 

The role reports to the Associate Director, Technical Product Management. This role will be a Remote role, with onsite travel to our headquarters in Brisbane, California as needed. 

What you’ll do:

• Define requirements and manage the development processes, systems, and software infrastructure for the data platform and tools supporting Commercial and R&D initiatives.
  • Partner with lab and business stakeholders to elucidate requirements, optimize workflows, and lead data platform and product definition, ensuring alignment with regulatory standards (e.g., HIPAA, HITECH).
  • Work with engineers to translate product requirements into Epics and Stories with clear user acceptance criteria.
  • Track and drive development and ensure fulfillment of requirements using issue tracking system (e.g., Jira).
  • Lead and facilitate productive interactions between users and engineers to ensure user needs are understood and met.
• Create a thorough technical strategy and roadmap to scale Freenome’s commercial data platform, tooling, and data products to support current and future products.
  • Provide a clear and tangible vision for future development efforts with scalability and accessibility in mind.
  • Ensure complete data integrity throughout the pipeline with technical and process-oriented solutions
    

Must haves:

• Bachelor’s degree in an analytical, technical, or scientific field; advanced degree preferred.
• At least 5 years of experience in a software development environment, ideally within biotechnology and NGS.
• Deep expertise in identification and prioritization of software features.
• Demonstrated ability to successfully lead complex trade-off decisions between functions and  measurably improve organizational success and processes.
• Experience leading software development efforts to meet regulated market standards (FDA, CAP/CLIA), laboratory operations, medical affairs, or clinical study operations for diagnostics.
  

Nice to haves:

• Experience in building solutions with a focus on multiomics, NGS, or proteomics a plus.

Benefits and additional information:

The US target range of our base salary for new hires is $118,150 - $167,475. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

#LI-REMOTE

About this opportunity:

Freenome is seeking a Strategic Account Executive (California) to help us redefine the landscape of early cancer detection by driving programmatic adoption of screening in health systems. The ideal candidate is proactive and driven and will be instrumental in adoption and implementation of Freenome’s early cancer detection tests, and digital health platform. The Strategic Account Executive will meet sales goals within the assigned geography by networking and building relationships with health systems and institutions. You will partner with the implementation team to ensure adoption of Freenome’s tests. The successful candidate will be assessed on quality and quantity of contracts in accordance with Freenome’s high performing standards.

The role will initially report to the Vice President of Sales. This role will be a Remote role within California and will require the ability to travel 50% of working time away from work location, may include overnight/weekend travel.

What you’ll do:

• Become a subject matter expert in Freenome’s technology and service offerings, effectively representing the company to key stakeholders including C-suite, executives, KOL physicians, Medical Directors, Hospital Administrators, Lab Directors, Precision Medicine Directors and Senior Management of Partner Labs
• Be an amazing sales person, effectively articulating the value of Freenome’s industry leading tests and digital health tools to executive and provider leadership within health systems
• Partner with Medical Affairs to educate and recruit Health Systems to utilize Freenome’s test
• Negotiate and close contracts with health systems and institutions
• Collaborate with both internal and external stakeholders in order to implement EMR and UX tools that will drive growth of Freenome’s test
• Capture information on customer interactions using CRM tools, including point of contact information, sales call activities, market intelligence, funnel development, and other data points
• Provide feedback to the Product and Marketing team directly from customers
• Structure detailed strategic plans for gaining and retaining health systems and institution contracts
• Identify market opportunities, monitor competitive activity, and present findings to commercial leadership
  

Must haves:

• Bachelor’s Degree in Sales, Business Management, Marketing or, Science, or any other related field
• 10+ years of medical sales experience and 3+ years with a strong record of success selling complex diagnostics solutions to health systems or institutions
• Experience with institutional sales successfully closing and implementing contracts with health systems
• Understanding of the healthcare system, reimbursement pathways, and screening protocols
• Strong communication, negotiation, and stakeholder engagement skills
• Strong presentation skills: ability to effectively convey concepts in a clear, concise, and professional manner through telephone and face-to-face interactions
• Experience with CRM tools and data-driven account planning
• Ability to sell technically complex products
• Possession of a valid driver's license

Nice to haves:

• Experience with liquid biopsy early cancer detection
• Demonstrated experience promoting digital health solutions to health systems
• Experience selling disruptive technologies and improving the standard of care
  

Benefits and additional information:

The US target range of our base salary for new hires is $175,000 - $210,000. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

#LI-REMOTE