Director, Clinical Operations

Overview The Director, Clinical Operations serves as a core member of the Product Development Team in the role of a Clinical Program Director (CPD) and is responsible for the development of the operational strategic plans for the clinical trials within the assigned program. This includes contributing to the development of the Clinical Development Plan, Product Strategy, Therapeutic Area Strategy, as well as several clinical documents (Clinical Protocols, IBs, CSRs, etc.). This role can be in the Bay Area, hybrid with 2-3 days in the office (Brisbane, CA) or can be remote. Responsibilities Accountable for operational strategic planning, oversight, and delivery of all Clinical Operations related activities within the development team and in accordance with the CDP. Accountable for providing direction, mentorship, and guidance to Clinical Operations staff assigned to the clinical program. Contributes at the strategic level including input into risk management plans, business value assessment, and therapeutic area indication operational expertise. Provides strategic operational guidance to ensure trials are properly defined, planned, and executed across all clinical stage programs. Contributes to the development of the clinical asset life cycle and clinical development plans; establishes the operational plan for a new program or study including scenario planning, high-level forecasting of timelines, assessment of program feasibility, estimation of resources and budget based on benchmarks, and development of high-level operational strategies. Reviews the operational plan with the therapeutic area, the Product Strategy Team, and functional leadership for alignment. Communicates initial budget, timelines, and changes to internal or external governance as appropriate. Provides proactive innovative and flexible operational solutions and options for the CDP. Accountable for meeting all operational deliverables in accordance with time, budget, and quality commitments. Maintains an overview of status, issues, and proactively communicates progress, issues, or changes that may impact timelines and costs of the program to all stakeholders. Maintains internal consistency across studies within a program and in alignment with functional standards across programs. Contributes to asset management and program management across Product Strategy Team as the CPD. Collaborates effectively with internal and external partners; ensures alignment of the operational program to the development team’s goals. Provides program guidance to matrix teams within Clinical Operations by providing program-specific guidance, clinical trial management expertise, operational strategies, and direction to achieve results. Mentors and guides Clinical Operations staff, including more junior CPDs. Provides timely feedback to functional managers regarding staffing needs and team member performance in the program. May be assigned to one or more complex programs. May 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 resources. May be responsible for line management and career development of Clinical Operations staff (Clinical Program Managers, Clinical Trial Managers, etc.). Qualifications BS in Scientific, Medical or Healthcare subject required. 1-2+ years of Clinical Operations experience (10+ years for MS degree) which includes experience in biopharmaceutical clinical trial management. Oncology experience is preferred. Extensive pharmaceutical industry and drug development experience including applicable global regulations and industry guidelines. Demonstrated effective global clinical program management across Phases I–III/II. Substantial experience in organization, implementation, and delivery of global clinical programs. Thorough understanding of all aspects of clinical drug development, with demonstrated experience in strategic planning, assessment of 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 knowledge of business, regulatory, and therapeutic advances impacting lifecycle planning or operational strategies. Meaningful analytical skills, including forecasting and data analysis; ability to analyze complex activities to draw reasonable conclusions. Demonstrated leadership, influencing, communication, and strategic project management skills. Strong communication skills; ability to engage and inspire others. Excellent team and interpersonal skills; fluent verbal and written English; other language skills may be an asset. Ability to work in a self-guided manner with appropriate consultation as needed. Travel Travel: Some to considerable national and international travel may be required (approximately 10-25% as needed). Location and Compensation This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote. The anticipated salary range for fully qualified candidates applying for this position is $240,000 - $250,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on factors including education, experience, tenure, skills, and alignment with market data. In addition to a competitive market-based salary, Arcus offers stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: Additional Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. EOE/AA/Vets #J-18808-Ljbffr Arcus Biosciences