Biomarker Technical Expert
- Collaborate closely with TSL, Clinical Operations, Biostatistics/Bioinformatics, and data management teams to support and execute translational science strategies in clinical trials;
- 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;
- 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 biomarker-relevant pages, coordination of biomarker data format and delivery timelines, data transfer specification setup, 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;
- Support Data analysis including processing of data files, curation and integration of datasets, generation of tables, figures and listings;
- Participates in or co-leads motivated and engaged teams in-line with Bayer’s VACC (Visionary, Architect, Catalyst, Coach) leadership standards by enabling, empowering, and supporting colleagues in a high-performance environment under a culture of psychological safety. As such, the BTE takes accountability for the respective outcomes and develops and maintains effective collaboration with study team members, diagnostic partners, external vendors and central labs;
- Evolves Translational Sciences Oncology’s unique value contribution by driving biomarker operation excellence and embracing a culture of creativity and innovation.
- Bachelor's degree;
- Extensive pharmaceutical industry experience and in-depth knowledge of clinical drug development;
- 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.
- Bachelor's degree with 5+years pharmaceutical or biotechnology industry experience required; Doctoral-level degree with 3+ year relevant experience and discipline or Master's degree with 5+ years in a relevant experience and discipline.
YOUR APPLICATION
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
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.
Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders. Bayer is an E-Verify Employer. Location: United States : Massachusetts : Cambridge || United States : Massachusetts : Boston Division: Pharmaceuticals Reference Code: 880289 Contact Us Email: [email protected]
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