Biomarker Technical Expert

Bayer•Cambridge, MA

2d•Onsite

About The Position

At Bayer, we are seeking a Biomarker Technical Expert to provide essential biomarker technical expertise and support to the Translational Science Lead (TSL). This role is crucial for the operational implementation and execution of translational science strategies in clinical trials, spanning phases I, II, and III. The Biomarker Technical Expert will manage all operational and logistical aspects of biomarker-related activities, ensuring the timely and high-quality delivery of data. The position involves working on multiple oncology projects and requires close collaboration with the TSL, various internal departments, and external partners. Key responsibilities include supporting clinical trial start-up, managing sample logistics, overseeing lab vendors (including companion diagnostics partners), providing data management support for collection, transfer, reconciliation, and reporting, assisting with document preparation, and supporting budget management.

Requirements

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

Nice To Haves

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

Responsibilities

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, ensuring the collection, delivery, and analysis of biomarker samples in compliance with these documents and 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 study teams, ensuring learnings are shared across teams (studies, programs), and identifying areas for best practice and process improvements.
Work with data management for the set-up and application of biomarker-relevant pages, coordination of biomarker data format and delivery timelines, and data transfer specification setup to ensure timely and efficient data delivery (data transfers, reconciliation, analysis, reports), including mutual data transfers with Companion Diagnostics (CDx) partners for CDx regulatory submissions, if needed.
Manage lab vendors, including contracting, data QC, delivery timelines, data transfers, and reporting.
Manage the implementation and execution of clinical biomarker sample logistics and operations, including site feasibility and training, sample management plans, lab manuals, and monitoring proper delivery.
Provide real-time sample oversight and drive ongoing sample reconciliation to support the selection of samples for analysis.
Support data analysis, including processing data files, curation and integration of datasets, and generation of tables, figures, and listings.
Participate in or co-lead 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.
Take accountability for respective outcomes and develop and maintain effective collaboration with study team members, diagnostic partners, external vendors, and central labs.
Evolve Translational Sciences Oncology’s unique value contribution by driving biomarker operation excellence and embracing a culture of creativity and innovation.