Associate Director, Clinical Operations

2 months ago

San Francisco, California, United States Nurix Therapeutics Full time

Job Summary:

Nurix Therapeutics, Inc. is seeking an Associate Director, Clinical Operations to join the Clinical Operations team. The successful candidate will be a core member of the Clinical Development Team and will contribute to development and implementation of the Clinical Development Plan (CDP), Product Strategy, Therapeutic Area Strategy, Clinical Study Protocol(s) (CSP), execution and oversight of clinical studies from Program initiation to final Clinical Study Reports (CSR). This person will be accountable for operational strategic planning, execution, oversight, and delivery of all Clinical Operations related activities within the development team and in accordance with the CDP and be accountable for providing direction, mentorship and guidance to Clinical Operations staff assigned to the clinical program.

Experience in managing cross-functional teams, knowledge of applicable regulatory requirements and developing junior staff will be essential to the team's success.

Responsibilities:

Makes broad contribution at strategic level including input into risk management plans, business value assessment and therapeutic area indication expertiseProvides strategic operational guidance to ensure trials are properly defined, planned, and executed across all clinical stage programsContributes to the development of clinical asset life cycle and clinical development plans and establishes the operational plan for a new program or study including scenario planning, high level forecasting of timelines, assessment of program level feasibility, estimation of resources and budget based on internal/external benchmarks, and development of high-level operational strategiesReviews the operational plan with the therapeutic area, Asset Team, and functional team members for alignmentCommunicates budget, timelines, and changes to internal or external governance as appropriateProvides proactive innovative and flexible operational solutions and options for the CDPContributes to global regulatory submissionsParticipates in licensing/ partnership assessment as needed, providing strategic input as well as operational elements in terms of costs, resources, and timelinesAccountable for meeting all operational deliverables in accordance with time, cost, and quality commitmentsMaintains an overview of status, issues, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to all stakeholdersMaintains internal consistency across studies within a program and in alignment with functional standards across programsContributes to asset management and program management across clinical sub-teams and/or Asset Team as the Clinical Operations leadCollaborates effectively with internal and external partners; ensures alignment of operational program to the development team's goalsProvides program guidance to matrix teams within Clinical Operations by providing program specific guidance, clinical trial management expertise, operational strategies, and direction to achieve resultsMentors and guides Clinical Operations staffProvides timely feedback to functional managers regarding staffing needs and team member performance in the programMay be assigned to one or more complex programsMay represent Operations or take a stakeholder role in company/function initiatives and regularly contribute to the optimization of existing as well as the development of new processes and resourcesResponsible for line management and career development of Clinical Operations staff (Clinical Program Managers, Clinical Trial Managers, etc.)Communicates with energy and passion, to engage and inspire others
Experience and Skills:BS in Scientific, Medical or Healthcare subject required. Advanced degree preferred.12+ years of Clinical Operations experience (8+years for M.S degree) which includes experience in biopharmaceutical clinical trial management, with a focus on oncology.Demonstrated effective global clinical program management across phases l-IV.Substantial experience in organization, implementation, and delivery of global clinical programs.Thorough understanding of all aspects of clinical drug development, demonstrated experience in strategic planning, demonstrated ability to understand and critically assess the global clinical development plans, protocol design, resource needs, global budgets and timelines for studies and programs.Experience in developing teams in a matrix and growing environment.Ability to maintain relevant knowledge of business, regulatory, and therapeutic advances that may impact life cycle planning or ongoing operational strategies.Meaningful analytical skills, including previous experience with forecasting and analyzing various sources of data. Ability to analyze complex activities and information to arrive at reasonable conclusions.Demonstrated leadership, influencing, communication and strategic project management skills.Communicates with energy and passion, to engage and inspire others. Has ability to work in a fast-paced environment.Demonstrated ability to understand and implement clinical development strategies. Ability to anticipate and resolve problems.Demonstrated excellent team and interpersonal skills.Effective communication skills: fluency in verbal and written English, any other language skills may be an asset.Ability to work in a self-guided manner with appropriate consultation as needed. Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy ( ).

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