Manager, Clinical Biomarker Operations
$143k - $178kRevolution Medicines
Revolution Medicines is a global commercial-state oncology company dedicated to discovering developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform the company is advancing a broad integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active cancer-driving state of on rigorous scientific inquiry and a willingness to challenge long-held assumptions Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.
Our people are united by a shared way of working: follow the science challenge assumptions act with urgency and hold ourselves to a high standard of rigorall in service of patients.
The Opportunity:
Playing a critical role as a Manager Biospecimen Operations within Translational Medicine function the position will be providing biomarker operational expertise in developing scope of work and maintaining effective working relationships with cross-functional teams for phase three clinical trials.
Lead endtoend biomarker operations across Phase IIII oncology clinical trials including protocol reviews prospective testing strategies sample lifecycle oversight data management query resolution and vendor qualification and contracting.
Collaborate crossfunctionally with Biomarker Leads Companion Diagnostics Clinical Operations and Data Management on reviews of protocol ICF eCRF DTS Genomic Verification Forms and eTMF documentation to ensure operational alignment.
Oversee central lab activities including operational lab startup lab manual and site requisition form SOW reviews and budget evaluation.
Manage relationships with specialty biomarker labs including sample logistics oversight testing strategy alignment RUO data transfer execution issue and query resolution invoice review and coordination of recurring operational meetings.
Contribute to SOP development operational process optimization and biomarker program initiatives to support biomarker operation excellence.
Support TM deliverables including IA data reviews CSR and regulatory submissions for CDx filings.
Drive vendor selection qualification onboarding and participate in audits to ensure adherence to regulatory and quality standards.
Provide biomarker operational metrics and study updates to crossfunctional teams and senior leadership to support strategic decisionmaking.
Review ICFs and respond to EC and IRB inquiries related to biomarker components.
Bring experience in diagnostic operations supporting CDx development and regulatory filings including sPMA submissions.
Utilize IRT and EDC systems to enable realtime sample tracking data integration and prompt query resolution.
Required Skills Experience and Education:
Life sciences degree (BS or MS) in scientific medical healthcare or related discipline.
7 years related professional experience in a clinical research setting clinical/diagnostic laboratory.
Should have experience mentoring team members.
Prior experience in clinical biomarker and CDx operations in phase one to three clinical trials is strongly preferred.
Prior experience in TruTech SLOPE and LIMS platforms is highly desirable.
Excellent scientific and business communication skills strong interpersonal/collaboration skills and planning skills.
Should be proficient in Microsoft Excel Microsoft PowerPoint applications.
Experience in using Project Management tools is highly desired.
Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
Ability to multi-task and thrive in a fast-paced innovative environment.
A great teammate who listens effectively and invites response and discussion.
Commitment to Revolution Medicines Core Values: Tireless Commitment to Patients Transformative Science Exceptional Together Total Integrity Inclusiveness and Fairness.
Preferred Skills:
Should be proficient in Microsoft Excel Microsoft PowerPoint applications.
Experience in using Project Management tools is desirable.
Experience in using LIMS Sample Management tool is desirable.
Experience with next-generation sequencing (NGS) methods for RAS mutation analysis is desirable.
#LI-EM1 #LI-Hybrid
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role level and location. Individual base pay salary is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed which includes competitive cash compensation robust equity awards strong benefits and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital status medical condition and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect process and use any personal data that you provide to us in accordance with our CCPA additional information please contact .
Base Pay Salary Range
$143000 - $178000 USD
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms email phone or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information purchase equipment or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @ email address. If you believe youve been contacted by someone impersonating a Revolution Medicines recruiter please report it to so we can share these impersonations with our IT team for tracking and awareness.Required Experience:
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