Nurix, Inc. is seeking a Clinical Trial Manager (CTM)/Sr. CTM to join the Clinical Operations team. This individual will be responsible for management of global clinical programs. They will lead study team, vendors, clinical monitors, and clinical sites throughout the life cycle of a clinical trial.
This individual will be able to manage clinical trial(s) and have broad involvement in work central to Nurix’s strategic goals. They will apply existing technical skills, learn new skills, and play a key role in nonclinical development of the programs and help grow the company and guide its direction. As an early hire, they’ll be influential in championing and developing Nurix’s culture.
CTM/Sr. CTM is responsible for the successful implementation of a clinical trial, independently, from start-up to close-out. Experience in managing cross-functional teams, knowledge of applicable regulatory requirements and developing junior staff will be essential to the team’s success. The CTM/Sr. CTM will represent Clinical Operations at Project team meetings and may represent Nurix at professional events.
Responsibilities:
- Accountable for all operational aspects of assigned clinical trial(s)
- Responsible for selection of vendors/CROs and provide effective ongoing management to vendors/CROs to ensure compliance and execution of deliverables within the approved budget, study timeline, and study protocol.
- Works closely with investigative site personnel, CROs, and other study vendors
- Monitor and track clinical trial progress and provide status update to stakeholders
- Manage study contracting, budget, forecasting, accruals, and payment process for all clinical trial vendors including investigational sites
- Collaborate with Data Management to ensure correct CRFs content is collected, prepare/implement CRF completion guidelines, and coordinate delivery of data listings and study reports
- Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports.
- Must be able to participate in cross-functional strategic initiatives under limited supervision
- Proactively identifies potential issues/risks and recommends/implements solutions.
- Provides leadership to the clinical operations team working on the assigned program.
Experience and Skills:
- B.S./ B.A. in biological sciences, advanced degree preferred with 5+ years of relevant industry experience
- Ability to travel as required for the program (10-15%)
- Demonstrated knowledge of FDA, ICH and GCP regulations and guidelines
- Experience in leading teams, including CROs, consultants and vendors.
- Must display strong analytical and problem-solving skills at a project level and collaborate with colleagues to generate solutions
- Strong communication and influence skills and ability to create a clear sense of direction
- Ability to deal with time demands, incomplete information or unexpected events
- Outstanding organizational skills with the ability to multi-task and prioritize
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
Company:
Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.
Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.
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