Personalis is a rapidly growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. Our ImmunoID NeXT Platform® is enabling the development of next generation immuno-oncology therapeutics and diagnostics.

Summary:

The Clinical Trial Senior Manager leads Clinical operations activities of Personalis In Vitro Diagnostics (IVD’s) and partnerships for companion diagnostics (CDx).

This individual will require interacting with a pharma and other partners to meet the clinical study operations activities that include assessment of therapeutic clinical protocols, authoring the data management plans for the Personalis Next Generation Sequencing (NGS) platforms. The position will coordinate the following activities:

  • Author data management plans and managing clinical research associates.
  • Manage Clinical study operations team with the IVD programs in coordination with, clinical development, regulatory and the quality teams
  • Track Timelines, Milestones, Deliverables, Resources and Costs.
  • Oversee IVD, clinical study operations and clinical study management. This includes Personalis laboratory developed tests and IVD products being submitted for FDA approval and companion diagnostic development.
  • Manage CRO partnership
  • Lead participation in biopharma CDx clinical studies and compliance discussions with Investigational Device Exemption requirements.
  • Manage study sample repository.

Ideally, the candidate will have a strong working understanding of clinical study operations, people management skills.  Next generation sequencing knowledge is a plus. Managerial experience and leading team meetings are highly desirable.  This role will have a unique opportunity to manage and contribute to the development of new clinical platforms at Personalis.

Responsibilities:

  • Manage a team of clinical research associates.
  • Lead clinical study operations activities for CDx Programs.
  • Collaborate in execution of clinical validation studies to support clinical programs.
  • Support the program sponsor in preparation of clinical study operations.
  • Manage the clinical study operations, sample repository and data management.
  • Ensure internal and external milestones, deliverables, and obligations are met.
  • Partner collaboratively with the Regulatory Affairs and Quality Assurance Teams to ensure that all internal SOP’s and FDA submission documentation meet quality standards.
  • Take ownership of key partner-related issues and work with appropriate internal teams to resolve.
  • Travel 0-5%

Requirements:

  • BS or MS in biological science or related field.
  • 4+ years working in industry (Clinical, IVD or Pharma).
  • Clinical Trial Management Certificate or related
  • People management skills
  • Familiar with Electronic Data Captures (EDC) platforms.
  • Familiar with Trial Master File (TMF)
  • Clinical study operations in a Diagnostic or Biopharma environment.
  • Involved with products in clinical or regulated environment (such as with FDA-CDRH/CDER, CLIA, CAP).
  • Demonstrated history of successfully managing multiple concurrent initiatives and managing clinical operations team.
  • Demonstrated track record of timely completion within deadlines.
  • Demonstrated ability to work in a dynamic fast paced team environment.
  • Strong interpersonal skills that include excellent skill in collaboration and problem solving with other departments and colleagues.

Business acumen:

  • Strong people management skills, influencing and interpersonal skills.
  • Self-starter.
  • Team player.
  • Result oriented.
  • Able to work under pressure.
  • Strong communication skills.
  • Strong planning and organizational skills.
  • Excellent knowledge of English (written and spoken).

Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities.  Personalis offers a competitive compensation package. 

 

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