Jobs · Information Technology · California

Senior Director, Clinical Data Management

Nurix Therapeutics · Brisbane, CA · 3 wk ago
Information TechnologyFull-time

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. We aim to improve treatment options for patients with cancer and inflammatory diseases through an AI-integrated discovery engine and unparalleled ligase expertise, translating science into clinical advancements.

About the role

The Senior Director of Clinical Data Management (CDM) is an experienced leadership role responsible for the delivery and integrity of clinical data across Nurix’s multiple studies and programs. This role 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). The ideal candidate will lead a large or specialized team, manage vendors, and represent the CDM function in interactions with senior stakeholders, including Nurix’s Executive Management Team and external thought leaders.

Responsibilities

  • Lead and manage assigned programs, ensuring alignment and consistency in data collection and processing activities.
  • Manage vendors contracted to handle Nurix’s clinical data, ensuring 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 teams to coordinate planning and execution of clinical data management activities.
  • Lead the design of eCRFs to align with clinical protocols.
  • 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 to 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 on project conventions, standards, practices, and database specifications.
  • May assist in forecasting and managing budgets for resources and program costs.
  • May act as an independent contributor to perform clinical data management activities for assigned programs or studies.
  • May mentor and develop direct employees and/or manage a group of internal and 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, including other managers.
  • Demonstrated ability to operate and lead in a dynamic organization, building successful working relationships and effective stakeholder management.
  • 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.

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.

Similar jobs