Sr. Director/ Vice President of Clinical Operations

Employer
Location
Menlo Park, California
Salary
Competitive salary and benefits
Posted
May 30, 2018
Closes
Jul 30, 2018
Position
Medical Director
Education
BS
Career Fair Category
Career Fair

Sr. Director/ Vice President of Clinical Operations

The Vice President, Clinical Operations, will provide overall direction for the GRAIL Clinical Operations organization including hiring, mentoring, professional development and performance management of the staff, as well as oversight for implementation 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 innovative technology, which will be critical to the results of a clinical program which aims to conduct clinical trials at an unprecedented scale. Given the scale and scope of the clinical programs and aggressive timelines set forth, this individual needs to exhibit creativity to scale operations across multiple large programs.

You Will:

  • Provide clinical operations direction and perspective in defining the GRAIL Clinical Operations organization and overseeing its processes and implementation 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 leadership oversight throughout the life of all assigned clinical projects. Proposes vendors for approval
  • Create patient recruitment strategies, operational feasibility and implementation path of the study/program goals; manages and communicates to the executive team and key stakeholders.
  • Work with other Clinical team members 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 quarterly annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations.

Your Background Should Include:

  • 15+ years of progressive experience in clinical research and/or clinical trial operations, and a minimum of 8 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 implementation 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.
  • Excellent 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 motivation skills to motivate staff and cultivate quality processes.
  • Excellent verbal and written communication and presentation skills, interpersonal and negotiation skills, organizational and problem
  • Demonstrated, effective planning and project organization skills, including risk assessment, contingency planning and ability to prioritize effectively.
  • Ability to travel as required (up to 25%).We are an equal opportunity employer and value diversity at our company.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.