Director, Clinical Operations

Summary

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 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.
• Makes broad contribution at 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 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 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 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.
• 12+ years of Clinical Operations experience (10+years for M.S 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 l-III.
• 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.
• 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.

• Travel: Some to considerable national and international travel may be required (~10-25% as needed)