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Senior Clinical Trial Manager
South San Francisco, California, United States
Who we are
Since 2006, 23andMe’s mission has been to help people access, understand, and benefit from the human genome. We are a group of passionate individuals pushing the boundaries of what’s possible to help turn genetic insight into better health and personal understanding.
23andMe's Therapeutics team is committed to discovering and developing new therapies that can offer significant benefits for patients. This dedicated research and development group in South San Francisco identifies novel targets using 23andMe's genetic database and performs preclinical research to advance programs for disease areas with high unmet need.
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.
More information about our Therapeutics team is available at https://therapeutics.23andme.com/.
What you’ll do
- Lead cross-functional study management teams responsible for the direction and oversight of Phase 1-3 clinical trials.
- Lead the CRO and critical vendor selection process for outsourced activities, including development of scope of services agreements, budgets, plans and timelines. Ensure that performance expectations are met by third party vendors.
- Support the forecast and management of project budgets, including long range forecasting of clinical trial costs.
- Develop and execute operational plans, including leading investigator meetings and supporting study recruitment.
- Provide technical expertise for the development of clinical documents (protocols, informed consent forms, laboratory manuals, case report forms, monitoring plans, regulatory submission documents, clinical study report, investigator brochures, etc.)
- Identify gaps in the clinical program and its resourcing; perform project risk analyses, and implement solutions.
- Identify and recommend improvements that can carry an impact across multiple Research and Development areas and teams
- Operate with considerable independence and autonomy on most assignments. Serve as a subject matter expert on projects and interpret and present complex data with minimal to no guidance.
- May support development of clinical operations quality systems, including standard operating procedures, document management, personnel training, and quality control processes
- May support development of department goals and objectives
- May manage Clinical Operations personnel directly
What you’ll bring
- BS, MS or PhD in life sciences or a relevant field.
- Expertise in the areas of drug development, operations, and strategic planning, including clinical trial operations.
- Demonstrated knowledge of international clinical pharmaceutical standards, FDA/EMA/ICH/GxP guidelines, and regulatory compliance.
- Experience leading cross-functional study management teams in the pharmaceutical or biotechnology industry.
- Significant experience in oncology and one or more additional disease areas of relevance to 23andMe Therapeutics.
- Experience managing CROs or other external vendor deliverables and relationships.
- Demonstrated comprehension of product and safety profiles.
- Proven effectiveness supporting study plan achievement to deliver data for filings and/or publications.
- 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.
- Consistent application of best practice project management techniques to assigned work and optimizes use of project management tools.
- Routinely goes out of her/his way to help others. Takes initiative to support the whole team. Appreciates and leverages diversity across the team. Highly regarded as a trusted advisor to cross-functional partners and stakeholders.
- Proactive and highly self-motivated with strong analytical and troubleshooting skills.
23andMe, Inc. is the leading consumer genetics and research company. Our mission is to help people access, understand and benefit from the human genome. The company was named by MIT Technology Review to its “50 Smartest Companies, 2017” list, and named one of Fast Company’s “25 Brands That Matter Now, 2017”. 23andMe has millions of customers worldwide, with more than 80 percent of customers consented to participate in research. 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 email@example.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.