Director, Clinical Operations
Arcus Biosciences
5 hours ago
Remote friendly (Brisbane, CA)
United States
Clinical Research and Development
Responsibilities:
- Accountable for operational strategic planning, oversight, and delivery of all Clinical Operations activities within the development team in accordance with the CDP.
- Provide direction, mentorship, and guidance to Clinical Operations staff assigned to the clinical program.
- Contribute strategically to risk management plans, business value assessment, and therapeutic area indication operational expertise; guide trials to be properly defined, planned, and executed across clinical-stage programs.
- Contribute to clinical asset life cycle and clinical development plans; establish operational plan for new programs/studies (scenario planning, timeline forecasting, feasibility assessment, resource/budget estimation using benchmarks, high-level operational strategies).
- Review operational plans with therapeutic area, Product Strategy Team, and functional leadership for alignment; communicate budgets, timelines, and changes to governance.
- Provide proactive, innovative, and flexible operational solutions.
- Ensure operational deliverables are met to time, budget, and quality; maintain program status/issue oversight and proactively communicate impacts to stakeholders; maintain internal consistency across studies.
- Contribute to asset/program management across the Product Strategy Team as the CPD.
- Collaborate with internal/external partners to align operational program to development goals.
- Provide program guidance to matrix Clinical Operations teams; offer clinical trial management expertise and operational strategies.
- Mentor and guide Clinical Operations staff, including junior CPDs; provide feedback on staffing needs and performance; may include line management/career development.
- May be assigned to one or more complex programs; may represent Operations in initiatives and process/resource optimization.
Qualifications:
- BS in Scientific, Medical, or Healthcare subject (required).
- 12+ years Clinical Operations experience (10+ years with an M.S.), including biopharmaceutical clinical trial management.
- Oncology experience (preferred).
- Extensive pharmaceutical industry/drug development experience with applicable global regulations and industry guidelines.
- Demonstrated global clinical program management across phases I–II.
- Substantial experience organizing, implementing, and delivering global clinical programs.
- Thorough understanding of clinical drug development; experience with strategic planning, protocol design, resource needs, global budgets, and timelines.
- Experience developing teams in a matrix/growing environment.
- Analytical skills including forecasting and analyzing data from multiple sources.
- Demonstrated leadership, influencing, communication, and strategic project management skills.
- Effective verbal and written English communication (additional language skills are an asset).
- Ability to work self-guided with appropriate consultation.
- Travel: ~10–25% national/international (as needed).
Benefits:
- Stock programs, performance-based bonus, and comprehensive benefits package.
- Salary range: $240,000–$250,000 USD annually.
Application/Location:
- Remote or based at Hayward or Brisbane, CA (preferred).
- Accountable for operational strategic planning, oversight, and delivery of all Clinical Operations activities within the development team in accordance with the CDP.
- Provide direction, mentorship, and guidance to Clinical Operations staff assigned to the clinical program.
- Contribute strategically to risk management plans, business value assessment, and therapeutic area indication operational expertise; guide trials to be properly defined, planned, and executed across clinical-stage programs.
- Contribute to clinical asset life cycle and clinical development plans; establish operational plan for new programs/studies (scenario planning, timeline forecasting, feasibility assessment, resource/budget estimation using benchmarks, high-level operational strategies).
- Review operational plans with therapeutic area, Product Strategy Team, and functional leadership for alignment; communicate budgets, timelines, and changes to governance.
- Provide proactive, innovative, and flexible operational solutions.
- Ensure operational deliverables are met to time, budget, and quality; maintain program status/issue oversight and proactively communicate impacts to stakeholders; maintain internal consistency across studies.
- Contribute to asset/program management across the Product Strategy Team as the CPD.
- Collaborate with internal/external partners to align operational program to development goals.
- Provide program guidance to matrix Clinical Operations teams; offer clinical trial management expertise and operational strategies.
- Mentor and guide Clinical Operations staff, including junior CPDs; provide feedback on staffing needs and performance; may include line management/career development.
- May be assigned to one or more complex programs; may represent Operations in initiatives and process/resource optimization.
Qualifications:
- BS in Scientific, Medical, or Healthcare subject (required).
- 12+ years Clinical Operations experience (10+ years with an M.S.), including biopharmaceutical clinical trial management.
- Oncology experience (preferred).
- Extensive pharmaceutical industry/drug development experience with applicable global regulations and industry guidelines.
- Demonstrated global clinical program management across phases I–II.
- Substantial experience organizing, implementing, and delivering global clinical programs.
- Thorough understanding of clinical drug development; experience with strategic planning, protocol design, resource needs, global budgets, and timelines.
- Experience developing teams in a matrix/growing environment.
- Analytical skills including forecasting and analyzing data from multiple sources.
- Demonstrated leadership, influencing, communication, and strategic project management skills.
- Effective verbal and written English communication (additional language skills are an asset).
- Ability to work self-guided with appropriate consultation.
- Travel: ~10–25% national/international (as needed).
Benefits:
- Stock programs, performance-based bonus, and comprehensive benefits package.
- Salary range: $240,000–$250,000 USD annually.
Application/Location:
- Remote or based at Hayward or Brisbane, CA (preferred).