Director of Clinical Operations

Organization
GRAIL, Inc.
Job Location
Redwood City, CA
Job Description

The Director, Clinical Operations, will provide overall leadership for the GRAIL Clinical Operations organization including hiring, mentoring, professional development and performance management of the staff, as well as oversight for execution of clinical programs including timelines, budgets, resources, clinical trial sites, vendors and key project deliverables. The position includes responsibility for continuous improvement of scalable and rigorous department infrastructure and processes through the development of SOPs, guidelines and the use of technology, which will be critical to the success of a clinical program which aims to conduct clinical trials at unprecedented scale. 

  • Provide clinical operations leadership and perspective in defining the GRAIL Clinical Operations organization and overseeing its processes and execution of clinical study programs.
  • Ensure operational feasibility of clinical development plans and scenarios, including timeline, budget and resource requirements. Ensure all study activities are completed in accordance with ICH GCP, health authority regulations and SOPs.
  • Lead strategic discussions regarding program and study resourcing, including outsourcing requirements at the study, program, and corporate levels.
  • Guide study team in vendor selection and provide management oversight throughout the life of all assigned clinical projects. Proposes vendors for approval.
  • Determine patient recruitment strategies, operational feasibility and implementation path of the study/program objectives; manages and communicates to senior management and key stakeholders.
  • Work with other Clinical team leaders to review the study documents including clinical trial protocol, amendment, informed consent form, case report forms, investigator brochure, site and third party vendor contracts, clinical study reports, etc.
  • Partner with Business Development in managing relationship with corporate partners on studies/programs, as applicable, for clinical operations.
  • Identify and provide solutions and direction related to key cross-­functional, sponsor-­site, and sponsor­-CRO clinical trial issues.
  • Develop, implement and maintain standards across clinical programs to ensure scalability and rigor of GRAIL Clinical Operations.
  • Hire, supervise and train operations personnel (CPM, CTM, CTA, etc.) and assume ownership of the quality of clinical programs and deliverables. Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations.

 

Requirements

PREFERRED BACKGROUND

  • 10+ years of progressive experience in clinical research and/or clinical trial operations, and a minimum of 3 years in a supervisory role managing clinical operations staff.
  • BA/BS in life sciences or healthcare field required; advanced degrees (e.g. Ph.D.) highly desired. Additional coursework in clinical trial design and execution strongly desired.
  • Industry experience within pharmaceutical, biologics or medical device fields, with in vitro diagnostics (IVD) and genomic medicine highly preferred.
  • Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
  • Strong track record of effective performance in cross-­functional environment, including successful relationships with data management, bioinformatics, biostatistics, medical writing, and regulatory affairs.
  • People management and team leadership skills to motivate staff and drive quality processes.
  • Excellent verbal and written communication and presentation skills, interpersonal and negotiation skills, organizational and problem solving skills.
  • Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize effectively.
  • Ability to travel as required (up to 25%). 
About Our Organization

GRAIL, Inc. is developing paradigm-­changing clinical assays for early cancer detection, based on unique biological insights from high-­intensity sequencing analysis of circulating cell-­free nucleic acids. We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to dramatically reduce the global burden of cancer.

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