Senior Manager, Biomarker Operations
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Description
Fate Therapeutics is looking for a Senior Manager, Biomarker Operations to help advance innovative clinical programs by shaping and executing biomarker sample strategies across studies. This is an exciting opportunity for a collaborative, detail-oriented operations professional who enjoys partnering across scientific, clinical, and vendor teams, solving complex challenges, and improving processes that support high-quality study execution. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities
- Lead day-to-day biomarker sample operations for clinical studies, including sample logistics, issue resolution, protocol amendments, lab manual updates, study initiation materials, and escalation of study-related risks.
- Partner with Translational and Clinical teams to design and implement innovative, feasible biospecimen collection and handling approaches that uphold quality, ethical, and informed consent standards.
- Maintain accurate sample inventories and oversee short- and long-term sample storage solutions.
- Collaborate with cross-functional stakeholders, including Translational Scientists, Medical Monitors, Clinical Operations, Finance, Procurement, Legal, Data Management, and Quality Assurance.
- Work with Quality Assurance to support vendor qualification and audit activities.
- Manage CROs and external laboratories to ensure key deliverables, timelines, sample processing, testing, and data reporting meet study specifications and business requirements.
- Organize and facilitate meetings with internal and external stakeholders to support alignment and timely execution.
- Oversee central lab budgets, contracts, MSAs, legal agreements, and other agreements related to clinical biomarker activities, laboratories, and partnerships.
- Coordinate with Clinical and IT teams to manage data reporting from CROs into Fate and clinical study vendor systems, as appropriate.
- Provide cross-functional study updates to clinical study and biomarker teams, including sample collection, assay status, and analysis updates.
- Develop and update SOPs for cross-functional biomarker operational processes.
Qualifications
- MS or higher degree with 3+ years of experience in biomarker operations, or BS degree with 5+ years of relevant experience.
- Demonstrated experience managing clinical or biomarker operations from study initiation through completion, including collaboration with central labs and CROs to execute biomarker study plans.
- Experience working with clinical trial sites and related clinical CROs.
- Knowledge of cancer biology, immunology, biomarkers, drug development, and clinical trial methodology is a plus.
- Experience with one or more Laboratory Information Management Systems (LIMS) is strongly preferred.
- Prior experience or familiarity with IND preparation and filing is preferred.
- Strong planning, organization, and follow-through, with the ability to manage multiple high-priority projects and competing deadlines in a dynamic environment.
- Excellent interpersonal, verbal, written communication, presentation, and influencing skills.
- High emotional intelligence and a collaborative approach to working effectively across cross-functional teams.
- Innovative mindset with the ability to introduce new ideas, improve processes, and solve problems creatively.
- Flexibility in schedule and willingness to travel as needed.
Working Conditions & Physical Requirements
- Travel may be required (up to 10%).
- Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Compensation
- The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
- Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
- The anticipated salary range for this role is $150,000 - $165,000.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment Opportunity
Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
Privacy Notice
To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit .
⚠️ Recruitment Fraud Alert
Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker’s personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams.
Here are a few things to be aware of to help identify recruitment fraud:
- Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.
- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.
- We will only ask for personal information when applying for a position via our Careers page or thereafter.
- At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.
- We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews.
Please exercise caution. If something feels off about your interactions, we encourage you to contact us at careers@fatetherapeutics.com to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.
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