Clinical Trial Manager CTMSr CTM

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 AIintegrated discovery engine capable of tackling any protein class and coupled with unparalleled ligase expertise Nurixs dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degraderbased treatments at the forefront of patient care writing medicines next chapter with a new script to outmatch disease.

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 assigned clinical trials and/or global regions. 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 regions and/or trial(s) and have broad involvement in work central to Nurixs strategic goals. They will apply existing technical skills learn new skills and play a key role in clinical development of the programs.

The CTM/Sr. CTM is responsible for the successful implementation of assigned clinical trial(s) independently from startup to closeout. Experience in managing crossfunctional teams vendor oversight knowledge of applicable regulatory requirements and developing junior staff will be essential to the teams success. The CTM/Sr. CTM will represent Clinical Operations at Project team meetings and may represent Nurix at professional events.

Job Responsibilities:

• Accountable for all operational aspects of assigned clinical trial(s) and/or geographical region.
• Develop and implement clinical trial protocols including study objectives inclusion/exclusion criteria and data collection procedures
• Responsible for selection of vendors/CROs and provide effective ongoing management and oversight to vendors/CROs to ensure compliance and of deliverables within the approved budget study timeline and study protocol
• Works closely with investigative site personnel CROs and other study vendors
• Manage relationships with site investigators and study coordinators
• Monitor and track clinical trial progress and provide status update to stakeholders
• Monitor recruitment progress and effectively address enrollment challenges
• 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 updates listings and study reports
• Drafts and coordinates review of relevant documents including protocols informed consents case report forms monitoring plans and relevant study plans investigator brochures and clinical study reports.
• Prepare for and manage regulatory agency audits and inspections
• Must be able to participate in crossfunctional 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 clinical trials

Experience and Skills

• B.S./ B.A. in biological sciences with 5 years of relevant industry experience
• Ability to travel as required for the program 25
• Demonstrate knowledge of FDA EMA ICH and GCP regulations and guidelines
• Experience managing global trials
• Experience in leading teams including CROs consultants and vendors
• Must display strong analytical and problemsolving 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 work independently multitask and prioritize
• Comfortable in a fastpaced 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 Nurixs extensive expertise in E3 ligases together with its proprietary DNAencoded 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. Nurixs 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.

Nurixs wholly owned pipeline comprises targeted protein degraders of Brutons tyrosine kinase a Bcell signaling protein and inhibitors of Casitas Blineage lymphoma protooncogeneB an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco California.

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Manager