Sr. Clinical Operations Consultant

Location
Menlo Park, California, United States
Posted
Nov 21, 2020
Ref
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Required Education
Bachelors Degree
Position Type
Full time
Adicet Bio, Inc. is a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors and T cell receptor-like antibodies to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. For more information, please visit our website at http://www.adicetbio.com.

SR. CLINICAL OPERATIONS CONSULTANT

The Sr. Clinical Operations Consultant will have responsibility for all day-to day trial management and vendor management for one or more clinical studies in the Adicet portfolio and will report directly to the Vice President of Clinical Operations. The Sr. Clinical Operations Consultant will also collaborate with the VP of Clinical Operations and other key functions both internally and externally to ensure successful completion of all clinical activities/study deliverables within the required time frame and budget.

KEY RESPONSIBILITIES:
  • Responsible for the operational strategy and execution for one or more clinical programs
  • Collaborate with the VP of Clinical Operations and other key functions both internally and externally to ensure successful completion of all clinical activities/study deliverables within the required time frame and budget.
  • Lead identification and selection of potential clinical vendors.
  • Serve as issue escalation point for vendors on assigned clinical programs, including clinical CROs
  • Accountable for the work product for the studie(s).
  • May manage direct reports including performance management and professional development planning for team members
  • Contribute to the planning and implementation of clinical studies including scenario planning, forecasting enrollment and timelines, estimation of resources and budget, and development of operational strategies.
  • Contribute to developing department processes to ensure adherence to Adicet standards, and all applicable regulations and guidelines.
  • Contribute to the development and maintenance of the necessary resource and budget forecasting for Clinical Operations.
  • Contribute and facilitate the development and maintenance of Clinical Operations
  • Contribute and facilitate the development of standard clinical trial management plans and tools.
  • Contribute and facilitate Clinical Operations' GCP compliance activities, reporting, and inspection readiness systems and activities.
  • Oversee clinical site and sponsor GCP inspection preparation and support activities.
  • Oversee study budget(s) and review/approve invoices.
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.

QUALIFICATIONS:
  • Bachelor's degree required. RN/PA with professional clinical experience, and/or Master's degree or higher in health-related science or equivalent preferred.
  • More than 10 years of experience managing Phase 1-4 clinical trials, both domestically and internationally (preference is for early phase oncology).
  • Experience bringing on and managing Contract Research Organizations (for clinical research)
  • May have experience managing direct reports.
  • Excellent organizational skills and attention to detail.
  • Effective communication and interpersonal skills.
  • Ability to efficiently perform multiple tasks and manage changing priorities.

ADICET FIT:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise.
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
  • Values-based leadership consistent with Adicet Core Values.
  • Excitement about the vision and mission of Adicet