Manager, Biomarker Operations

<div class="content-intro"><p><strong>About us:</strong></p> <p>We’re a startup biotechnology company dedicated to engineering a universal treatment across solid tumors. We’re committed to the development of novel cell therapies, and we’re using viral vectors, universal targets, and novel cytokine biology to enhance CAR T activity. Our therapeutic approach has the potential to enable us to treat significant numbers of cancer patients. Our company was founded on pioneering work carried out in the laboratories of Dr. Carl June and Dr. Andy Minn (University of Pennsylvania), Dr. Kole Roybal (UCSF), and Dr. Christopher Garcia (Stanford University).</p> <p> </p> <p>Our purpose is to help create a world where all cancer patients can be cured. We’re humbled by the opportunity to work together on some of the most pressing medical challenges of our time. At our company, you would become one of our early team members—not only playing a role in meeting our ambitious mission but also building our thriving culture.  We are determined to deliver with urgency to discover new solutions and we always stay dedicated to scientific rigor; we have an ownership mindset because each and every one of us is integral to our success.  Collaboration is core for us because we believe that by bringing people together with diverse perspectives, we make a stronger whole.  And, we show we care about our work and each other by sharing feedback - ultimately in service of our vision to empower people to continue forward with their lives – cancer free. </p> <p> </p></div><p><strong>The role:</strong></p> <p>The Biomarker Operations Manager will be responsible for the operational execution of the biomarker plan defined by Translational Sciences across preclinical and clinical programs. This role ensures high-quality, on-time delivery of biospecimen management, biomarker assay implementation, data flow, and vendor oversight to support clinical development and regulatory objectives. The ideal candidate is highly organized, detail-oriented, and comfortable operating in a fast-paced, high-efficiency biotech environment.</p> <p> </p> <p> </p> <p><strong>Key responsibilities:</strong></p> <p><strong>Biomarker & Translational Operations</strong></p> <ul> <li>Plan, execute, and track biomarker activities across clinical studies, including sample collection, handling, storage, shipment, testing, and data delivery.</li> <li>Translate biomarker strategy into operational plans, timelines, and budgets.</li> <li>Support implementation of exploratory, pharmacodynamic, pharmacokinetic, and safety biomarkers.</li> </ul> <p><strong> </strong></p> <p><strong>Biospecimen Management</strong></p> <ul> <li>Oversee biospecimen logistics, including site training, sample collection kits, chain of custody, and reconciliation.</li> <li>Ensure compliance with protocol, ICH/GCP, and applicable biosafety and ethical requirements.</li> <li>Maintain accurate sample inventories and documentation.</li> </ul> <p><strong> </strong></p> <p><strong>Vendor & Internal Laboratory Management</strong></p> <ul> <li>Manage external vendors (e.g., central labs, specialty labs, CROs).</li> <li>Oversee contracts, SOWs, timelines, deliverables, and budgets for biomarker-related vendors.</li> <li>Serve as primary operational point of contact for biomarker vendors.</li> <li>Oversee internal lab sample receipt, accessioning, storage, and chain-of-custody documentation.</li> </ul> <p><strong> </strong></p> <p><strong>Cross-Functional Collaboration</strong></p> <ul> <li>Partner closely with Clinical Operations, Translational Sciences, Research, Data Management, Regulatory, and Quality teams.</li> <li>Support protocol development, informed consent language, and clinical operations manuals related to biomarker activities.</li> <li>Contribute to study team meetings and program-level planning.</li> </ul> <p><strong> </strong></p> <p><strong>Data & Reporting</strong></p> <ul> <li>Ensure timely and accurate transfer of biomarker data to internal teams and data management systems.</li> <li>Support data review, query resolution, and integration with clinical datasets.</li> <li>Contribute to clinical study reports, regulatory submissions, and scientific communications.</li> </ul> <p><strong> </strong></p> <p><strong>Process Improvement</strong></p> <ul> <li>Develop and maintain work instructions, SOPs, workflows, and templates for biomarker operations.</li> <li>Identify opportunities to improve efficiency, quality, and scalability of biomarker execution.</li> <li>Support inspection and audit readiness related to biomarker activities.</li> </ul> <p> </p> <p> </p> <p><strong>Required experience & skills:</strong></p> <ul> <li>Bachelor’s degree in life sciences or related field (advanced degree preferred)</li> <li>At least 5 years of experience in biomarker operations, translational research, clinical operations, or laboratory project management</li> <li>Hands-on experience managing biomarker activities in clinical trials</li> <li>Strong understanding of biospecimen handling, laboratory workflows, and clinical trial operations</li> <li>Experience working with external vendors and CROs</li> <li>Excellent organizational, communication, and problem-solving skills</li> </ul> <p> </p> <p> </p> <p><strong>Preferred experience & skills:</strong></p> <ul> <li>Experience in oncology, cell therapy, gene therapy, or immunology</li> <li>Familiarity with regulatory expectations for biomarker data (e.g., FDA, EMA)</li> <li>Experience in early-stage or small biotech environments</li> <li>Knowledge of sample tracking systems, clinical data standards and LIMS (e.g., Benchling)</li> </ul> <p> </p> <p><strong> </strong></p><div class="content-conclusion"><p><strong>Our values:  </strong></p> <p>Our values guide everything we do. While capabilities and skills are vital, understanding how a potential new colleague would embody our values is central to our hiring decisions.</p> <p><strong> </strong></p> <p><strong>Determined to deliver:  </strong></p> <p>By working with focus and passion, we can provide patients with the solutions they need.  </p> <p><strong> </strong></p> <p><strong>Own every outcome:  </strong></p> <p>We can reach new heights when we stay centered on our shared success.  </p> <p><strong> </strong></p> <p><strong>Collaboration at the core:  </strong></p> <p>When we band together, our work is better.  </p> <p><strong> </strong></p> <p><strong>Feedback is fundamental:  </strong></p> <p>Constructive and authentic positive feedback may be difficult to master but it is vital to our success.  </p> <p><strong> </strong><strong> </strong></p> <p><strong>Working here:</strong></p> <ul> <li>We offer a highly competitive compensation package with meaningful ownership through equity</li> <li>Excellent coverage for medical, vision, and dental</li> <li>401(k) with generous contribution</li> <li>Life insurance</li> <li>Flexible PTO policy</li> <li>Additional substantial benefits</li> </ul> <p> </p> <p style="text-align: center;"><em>We are an equal opportunity employer.  </em></p> <p style="text-align: center;"><em>We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, </em><em>or any characteristic protected under applicable law.</em></p> <p> </p></div>