Director, Clinical Trial Operations

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

About the Role:

The Director of Clinical Trial Operations leads the Oncology Clinical Development team and is responsible for managing the diverse aspects of company oncology sponsored and supported clinical trials.  Such activities include study design and project planning, budget management, contracting, study execution, and data monitoring and analysis.  The Director is also responsible for long-term departmental project planning, including resource allocation for the timely completion of clinical trials.  The Director will engage study investigators and co-investigators.  As a leader of a team whose activities are essential to the long-term success of the organization, the Director will also ensure that appropriate training and processes are in place and that the team conducts its activities in accordance with health authority requirements and Good Clinical Practice.  The Director is responsible for hiring and retaining a diverse team of highly skilled professionals. The role is highly visible in the organization, with frequent exposure to senior management. 

Responsibilities:

• Develops and manages the Oncology Clinical Development team, including clinical trial managers, research associates, and data management staff.
• Oversees the project planning and execution of oncology clinical studies, including company sponsored, partner sponsored, and investigator sponsored trials.
• Identifies barriers to timely and successful study execution and proposes solutions to same, with regular reporting of study performance metrics.
• Assures compliance with all regulatory requirements associated with clinical research.
• Drives data collection, clinical trial database construction, and develops audits and database queries to verify data accuracy.
• Supports data and statistical analysis in support of study results and effectively communicates graphically in support of abstract and manuscript development.
• Develops study designs and protocols aimed to achieve company goals.
• Manages and controls budget planning and expenditures for Clinical Development according to Guardant Health policies.
• Manages contracting with research collaborators/investigational sites.
• Develops training and ongoing educational interventions to assure compliance with study protocols both externally and internally.
• Maintains personal and team proficiency in understanding of molecularly targeted therapies in oncology and an in-depth knowledge of genomic alterations in different cancer types.

Qualifications 

• Graduate level clinical degree (Masters level or above) in a discipline such as Nursing, Genetic Counseling, Pharmacy, Biological Sciences, or Medicine with 5 years of clinical trials leadership experience OR Bachelor level degree in similar area of focus with 10 years of clinical trials leadership experience. 
• Portfolio of experience includes management of oncology studies; first-hand clinical oncology experience (hospital or clinic setting) a plus
• Practical experience with clinical studies involving in vitro devices (IVD) a plus
• Demonstrated ability to manage multiple clinical studies simultaneously
• Solid organizational and business management skills
• Proficiency in relationship building, direct-line team management, and cross-functional team management
• History of mentoring/teaching
• Familiarity with FDA and other health authority guidelines regarding the conduct and reporting of clinical trials; experience with preparing materials for health authority review; presentation experience (written or face-to-face) a plus
• Ability to work independently as well as part of a cross functional team
• Excellent problem solving ability necessary
• Excellent written and verbal communication skills (proficiency in English required)
• Flexible attitude to adjust to evolving needs of investigators and company management
• Maintain appropriate professional licenses and certifications