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Clinical Trial Manager/Senior Clinical Trial Manager - 23andMe

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Job Title
Clinical Trial Manager/Senior Clinical Trial Manager
Job Location
South San Francisco, California
Job Description

Who We Are

23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.

This dedicated research and drug development group identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.

We are seeking an outstanding Senior Clinical Trial Manager to join a collaborative, cross-functional Development organization focused on bringing genetically-validated therapies to patients with high unmet need. Successful candidates will have experience independently planning and executing complex clinical trials.

 

What You’ll Do

  • Leads one or more cross-functional Study Management Teams responsible for the direction and oversight of Phase 1-3 clinical trials.
  • Acts as primary point of contact for external parties including sites, service providers, and ethics committees; 
  • Lead vendor activities for outsourced activities, including selection, development of scope of services agreements, budgets, plans, timelines, and enhancements. Monitor performance and ensure that expectations are met by third party vendors.
  • Manages site/IRB/EC reviews and coordinates cross-functionally; provides Clinical Operations responses for regulatory interactions as needed
  • Collaborates with internal and external stakeholders and acts as Clinical Operations lead for cross-functional study planning and activities (eg. study drug demand forecasting, data cuts, etc.)
  • Acts as escalation point for site and vendor issues; partners with internal and external stakeholders to investigate issues and identify solutions; escalates non-compliance concerns accordingly
  • Develop study and site budgets in collaboration with internal and external stakeholders; support management and reporting of trial budget and financial metrics
  • Plan and lead study trainings including Investigator Meetings; represent the Sponsor at site visits ie. SIV, RMV as necessary
  • Drafts and presents study updates to senior leadership as necessary
  • Authors and/or provides technical expertise for the development of clinical documents (protocols, informed consent forms, study manuals, case report forms, study plans, etc.); identifies deficiencies and initiates updates ongoingly
  • Develops and executes internal plans for Sponsor oversight of outsourced vendor activities and clinical site activities (eg. Monitoring Review, TMF QC, etc)
  • Identify and recommend improvements that can carry an impact across Clinical Operations and other functional areas and teams; develop and contribute to process and standard procedures that can be adopted across study teams
  • Operate with considerable independence and autonomy on most assignments
  • May support development of department goals and objectives
  • May manage Clinical Operations personnel directly

 

What You’ll Bring

  • BA/BS, MS or PhD in life sciences or a relevant field.
  • 6+ years of experience in clinical trial industry working for Sponsor or CRO
  • Experience working in global trials across multiple phases (I - III) is preferred
  • Oncology experience is preferred
  • Expertise in the areas of drug development, operations, and strategic planning, including clinical trial operations.
  • Demonstrated working knowledge and application of international clinical research guidelines (ICH/GCP) and regulations (FDA, EMEA, etc.
  • Experience leading cross-functional study management teams in the pharmaceutical or biotechnology industry.
  • Experience managing CROs or other external vendor deliverables and relationships.
  • Ability to think strategically; consistently works to improve Clinical Operations or team outcomes and ways of working
  • Advanced communication skills to convey complex information to both specialist and non-specialist audiences. Consistent communication in a manner that builds trust and enhances alignment with others.
  • Effectively collaborates with external and internal teams; routinely goes out of their way to help others to support the success of the team.
  • Proactive and highly self-motivated with strong analytical and troubleshooting skills.

Note:  Job title will be commensurate with experience and academic credentials

 

About Us

23andMe, headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company’s mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world’s largest crowdsourced platform for genetic research, with 80 percent of its customers electing to participate. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.

At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws.  If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at accommodations-ext@23andme.com. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.

Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.

23andMe Headquarters Location

Mountain View, CA

23andMe Company Size

Between 500 - 1,000 employees

23andMe Founded Year

2006

23andMe Funding Rounds

  • Post Ipo Equity

    $250,000,000 USD

  • Series F

    $82,500,000 USD

  • Corporate Round

    $300,000,000 USD

  • Series F

    $250,000,000 USD

  • Grant

    $1,700,000 USD

  • Series E

    $115,000,000 USD

  • Grant

    $1,400,000 USD

  • Series D

    $50,000,000 USD

  • Series C

    $9,000,000 USD

  • Series C

    $22,220,289 USD

  • Series B

    $14,200,000 USD

  • Series B

    $13,600,000 USD

  • Series A

    $8,953,320 USD