Senior Director, Clinical Data Management
About the role
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. This Senior Director of Clinical Data Management (CDM) role is responsible for the delivery and integrity of clinical data across Nurix’s multiple studies and programs. As a subject matter expert, this position owns the short- and long-term strategy, roadmap, budget, and resource plans for the CDM function, ensuring adherence to industry guidelines (including CDASH/CDISC and GCDMP) and advancing the function’s capabilities. The ideal candidate will play a leadership role in defining departmental policies, operational guidelines, and administrative structure in partnership with the Head of Clinical Data Management and Head of Biometrics.
Responsibilities
- Lead and manage assigned programs, which may consist of multiple studies, ensuring alignment and consistency in data collection and processing activities.
- Manage vendors contracted to handle Nurix’s clinical data, ensuring data completeness, accuracy, and timely delivery.
- Ensure inspection readiness by maintaining current documentation, adherence to industry guidelines, SOPs, and compliance with training.
- Collaborate with internal and external team members to coordinate the planning and execution of clinical data management activities.
- Lead the design of eCRFs and ensure alignment with clinical protocol(s).
- Ensure complete and accurate documentation, including eCRF specifications, completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans.
- Review data on an ongoing 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 final CSRs.
- Collaborate with the clinical development team and provide expertise on CDISC data standards, FDA and ICH guidelines, and GCDMP standards.
- Assist in 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 clinical data management activities for an assigned program or study.
- May mentor and develop direct employees and/or manage a group of internal and/or external team members as the department grows.
Requirements
- Bachelor’s degree in a scientific discipline (e.g., computer science, mathematics, statistics, epidemiology, biology, psychology) or equivalent experience.
- Minimum of 15 years of clinical data management experience within the 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 in regulatory requirements for clinical data management and the regulatory submission process.
- Extensive experience working with external vendors, including acquisition, contracting, evaluation of capabilities, and ensuring high-quality deliverables.
- Experience managing direct reports, typically including some experience managing other managers.
- Demonstrated ability to operate and lead in a dynamic organization, build successful working relationships, and manage stakeholders effectively.
- 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.
Skills
- Advanced communication skills to represent the CDM function in interactions with senior stakeholders, including Nurix’s Executive Management Team and external thought leaders.
- Ability to work closely with medical study directors and clinical operations to ensure high quality and integrity in clinical data.
Pay
Salary Range: $246,000 – $310,000
Fit with Nurix Culture and Values
- Strong team orientation; highly collaborative.
- Solutions and results-oriented focus.
- Hands-on approach; resourceful and open to diverse points of view.