Sr Clinical Biomarker Ops Manager (m/f/d) at CatalYm

Planegg, Bavaria, Germany -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

95000.0

Posted On

06 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Biomarker Operations, Vendor Management, Sample Management, GCP, Project Management, Clinical Trial Workflows, Bioanalytical Testing, CRO Management, Oncology Clinical Trials, Budget Tracking, Regulatory Documentation, Cross-functional Collaboration

Industry

Biotechnology Research

Description

Your mission As (Sr.) Clinical Biomarker Operations Manager, you will be responsible for the operational planning, coordination, and execution of clinical biomarker, translational sample, and bioanalytical activities across CatalYm’s clinical trials. You will ensure that biomarker-related trial activities are implemented reliably, samples are collected and processed according to protocol requirements, vendors are qualified, contracted, and managed effectively, and biomarker and bioanalytical deliverables are provided in a timely and high-quality manner. You will work closely with Translational Research, Clinical Development, Clinical Operations, Clinical Pharmacology and Bioanalytics, Data Management, Biostatistics, Regulatory Affairs, Legal/Procurement, external laboratories, central laboratories, and CROs to support robust operational delivery of the clinical biomarker & bioanalytical program. Your responsibilities include: Drive the operational implementation and execution of clinical biomarker, translational sample, and bioanalytical activities across ongoing clinical trials. Support planning and take responsibility for execution of biomarker-related trial activities, including sample collection, processing, shipment, tracking, reconciliation, laboratory testing coordination, and data transfer. Be responsible for the development, maintenance, and updates of biomarker- and bioanalytics-related sections of clinical trial documents, including protocols, laboratory manuals, sample handling instructions, vendor scopes of work, study plans, and relevant operational or regulatory documents. Lead operational set-up activities, including vendor identification, vendor qualification, contracting support, study start-up, sample logistics, assay readiness tracking, data transfer processes, and report delivery. Oversee external vendors, specialty laboratories, central laboratories, CROs, and other service providers involved in sample handling, biomarker testing, bioanalytical testing, data delivery, and reporting. Ensure biomarker and bioanalytical activities are executed according to study timelines, quality expectations, contractual agreements, protocol requirements, and relevant regulatory and GCP standards. Track operational milestones, risks, issues, and dependencies, and proactively drive resolution in collaboration with internal functions and external partners. Review vendor deliverables from an operational and quality perspective, including laboratory manuals, sample reconciliation outputs, data transfer files, status reports, and final reports. Facilitate cross-functional communication between internal functions, external partners, clinical sites, central laboratories, and specialty laboratories. Maintain clear documentation of operational plans, decisions, vendor communications, sample status, data transfers, contracts, study-level deliverables, and open issues. Support budget tracking, purchase orders, contracts, change orders, and invoice review for biomarker- and bioanalytics-related vendors. Contribute to continuous improvement of biomarker and bioanalytical operations processes, templates, vendor oversight practices, and cross-functional ways of working. Your profile Who you are: University degree in life sciences, biomedical sciences, clinical research, biotechnology, pharmacy, or a related discipline. Several years of experience in clinical trial operations, biomarker operations, clinical sample management, central laboratory operations, specialty laboratory coordination, CRO management, or a related operational role. Strong understanding of clinical trial workflows, including sample collection, processing, shipment, tracking, reconciliation, laboratory testing coordination, and data delivery. Experience managing external vendors such as central laboratories, specialty laboratories, CROs, bioanalytical laboratories, or biomarker testing providers. Experience with vendor selection, vendor qualification, contracting processes, scopes of work, purchase orders, change orders, and vendor oversight in a clinical trial environment. Familiarity with clinical trial documentation, including protocols, laboratory manuals, sample handling instructions, vendor scopes of work, data transfer specifications, and operational plans. Good understanding of GCP, clinical trial quality requirements, sample traceability, vendor oversight, and documentation standards. Experience working in oncology clinical trials and/or biomarker-related clinical studies is preferred. Strong project management skills, with the ability to coordinate multiple studies, vendors, timelines, contracts, budgets, and stakeholders in parallel. Structured, detail-oriented, proactive, and able to identify operational risks early and drive practical solutions. Excellent communication and collaboration skills, with the ability to work effectively across clinical, operational, laboratory, legal/procurement, and external partner teams. Why us? What we offer: The opportunity to contribute to the clinical development of a promising, innovative cancer therapy. A key operational role at the interface of translational research, clinical biomarkers, clinical operations, and clinical bioanalytics. A collaborative and purpose-driven team environment. A permanent employment contract with competitive compensation and attractive employee benefits. About us CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!

Responsibilities

Responsible for the operational planning and execution of clinical biomarker and bioanalytical activities across clinical trials. This includes managing external vendors, overseeing sample logistics, and ensuring compliance with GCP and protocol requirements.