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At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Biomarker Technical Expert II In Bayer Research & Early Development Oncology, we discover the next generation of cancer therapies with scientific innovation hubs in Berlin, Boston, Basel, and Oslo. Translational Sciences Oncology is a multidisciplinary department that harnesses cutting-edge technologies to enable earlier detection, precise molecular diagnosis, and personalized treatment for cancer patients. We ensure seamless translational support starting from the assessment of new targets through to preclinical and clinical studies from first-in-human through lifecycle management. The primary responsibility of this role is to provide biomarker technical expertise and support to the Precision Medicine Lead (PML) to ensure operational implementation and execution of Precision Medicine strategies in clinical trials which may include phase I, II and III studies. The BTE is responsible for all operational and logistical aspects of carrying out biomarker related activities to ensure timely and quality data delivery. Workload includes multiple projects in the area of oncology. The BTE will interface with the PML and multiple functions throughout the company as well as external partners to support and facilitate biomarker activities including clinical trial start up, sample logistics, lab vendor management (including companion diagnostics partners), data management related support for data collection, transfer, reconciliation and reporting, document preparation, budget support, and more. YOUR TASKS AND RESPONSIBILITIES The primary responsibilities of this role, Biomarker Technical Expert II are to: Develop and provide operational input into all study related documentation and processes, and ensure collection, delivery and analysis of biomarker samples in compliance with these documents as well as GCP/ICH; Deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic operational aspects; Contribute to Health Authorities and Ethics Committee exchanges; Serve as a single point of contact for biomarker operations across functions, and with collaborators and CROs; Provide biomarker operational expertise and guidance to the study teams and ensure learnings are taken across teams (studies, programs); identify areas of best practice and process improvements; Work with data management for set-up and application of BM-relevant pages, coordination of biomarker data format and delivery timelines (DTSsetup), to ensure timely and efficient data delivery (data transfers, reconciliation, analysis, reports), mutual data transfers with Companion Diagnostics (CDx) partners for CDx regulatory submissions, if needed; Lab vendor management including contracting, data QC and delivery timelines, data transfers and reporting; Manage implementation and execution of clinical biomarker sample logistics and operations including site feasibility and training, sample management plan, lab manual, monitoring of proper delivery. Provide real-time sample oversight and drive ongoing sample reconciliation to support selection of samples for analysis; Provide expertise and guidance related to operational Biomarker strategy implementation globally; Provide project management: accountability for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples; support budget management. WHO YOU ARE Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following: Required Qualifications: Bachelor's degree 5+years pharmaceutical or biotechnology industry experience; Extensive pharmaceutical industry experience; In-depth knowledge of clinical drug development and Precision Medicine; Clinical laboratory experience including involvement in the processing and/or analysis of clinical samples; Project management skills including planning, organizational and time management skills; Global vendor management experience; Critical reasoning skills including identification and resolution of complex problems; Detail oriented with the ability to work independently and manage multiple competing priorities; Proven project leadership skills, ability to successfully achieve results within multi-cultural and geographically diverse teams; Excellent oral/written communication skills; Preferred Qualifications: Doctoral-level degree with 3+ years relevant experience and discipline; Master's degree with 5+ years in a relevant experience and discipline; In-depth knowledge of oncology clinical drug development. Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. IMPORTANT NOTE for POTENTIAL US CANDIDATES:Bayer expects its colleagues to be fully vaccinated against COVID-19. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer colleagues are also required to comply with state, local and customer requirements. Division: Pharmaceuticals Reference Code 787777 Functional Area: Biotechnology R&D Location: United States : Massachusetts : Cambridge || United States : New Jersey : Whippany Employment Type: Regular Position Grade: VS 1.2 Contact Us Address Telephone E-Mail Creve Coeur, MO +1 888-473-1001, option #5 hrop_usa@bayer.com 63167 Bayer is an Equal Opportunity Employer/Disabled/Veterans