Bayer Biomarker Technical Expert II in Whippany, New Jersey
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Biomarker Technical Expert II
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 (DTS 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;
Provide 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 in China;
Support Data analysis including processing of data files, curation and integration of datasets, generation of tables, figures and listings;
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:
Bachelor's degree with at least five years of 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.
Doctoral-level degree with at least three years of relevant experience and discipline or Master's degree with at least five years in a relevant experience and discipline;
In-depth knowledge of oncology clinical drug development.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. 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.
Location: United States : Massachusetts : Cambridge || United States : New Jersey : Whippany
Reference Code: 349743
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