Director / Sr Director of Clinical Data Management

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 Purpose: The Director/Sr Director of Clinical Data Management (CDM) will be responsible for the delivery and integrity of clinical data across Nurix’s multiple studies/programs. This role will also support process development and improvement in building clinical data management infrastructure. The ideal candidate will ensure adherence to industry guidelines (including CDASH/CDISC and GCDMP) in all clinical data management activities for assigned programs/studies, as well as assisting the Head of Clinical Data Management and Head of Biometrics in the development and implementation of departmental policies, operational guidelines, and administrative structure. The successful candidate should have a successful track record in managing vendors and effectively leading program clinical data management activities with the anticipated growth in the product pipeline. They must also possess excellent communication skills to interface with leadership and study teams on behalf of the department and work closely with medical study directors and clinical operations to ensure high quality and integrity in clinical data

Responsibilities and Duties:

• Lead and manage assigned programs, which may consist of multiple studies, ensuring alignment and consistency in data collection and processing activities
• Manage vendors that have been contracted to handle Nurix’s clinical data and ensure the data are complete, accurate and delivered within the agreed upon timelines
• Ensure inspection readiness by maintaining current documentation, adherence to industry guidelines, SOPs and compliance with training
• Work collaboratively with internal and external team members within the program to coordinate the planning and execution of clinical data management activities
• Lead the design of the eCRFs and ensure that they align with the clinical protocol(s)
• Ensure complete and accurate documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans
• Ensure data is reviewed on an on-going basis, including individual subject data within the EDC and reconciliation with external data sources
• Manage timelines for data cleaning and other CDM activities in preparation for DSURs, IBs, publications and other business needs, or final CSRs
• Collaborate with clinical development team and provide expertise regarding CDISC data standards, FDA and ICH guidelines, and GCDMP standards
• Assist with establishing CDM processes and creating key CDM SOPs
• Provide technical leadership and guidance for other clinical data managers and vendors around project conventions, standards, practices, and database specifications
• May assist in forecasting and management of budgets for resources and program costs
• May act as an independent contributor to perform all clinical data management activities of an assigned program or study, as necessary
• May be required to mentor and develop direct employees and/or manage a group of internal and/or external team members, as the department grows

Required Qualifications:

• Bachelor’s degree in a scientific discipline (computer science, mathematics, statistics, epidemiology, biology, psychology, etc.) or equivalent experience
• Minimum of 12 years of clinical data management experience within pharmaceutical industry with a track record of success and progression
• Direct experience working with Medidata Rave design and implementation
• Direct experience with oncology studies across multiple study phases
• Proficient on regulatory requirements for clinical data management and the regulatory submission process
• Extensive experience working with external vendors, including but not limited to acquisition, contracting, evaluation of vendor’s capabilities and ensuring the desired high-quality deliverables
• Experience in managing direct reports is required
• Demonstrated ability to operate and lead in a dynamic organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise
• Strong team orientation; highly collaborative
• Solutions and results-oriented focus
• Hands-on approach; resourceful and open to diverse points of view
• Self-motivated and able to operate independently

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