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.


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.


  • 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%


  • 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. 



Apply for this Job

* Required

When autocomplete results are available use up and down arrows to review
+ Add Another Education

U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Personalis, Inc are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.