Biomarker Technical Expert

Bayer•Boston, MA

1d•$139,840 - $209,760•Onsite

About The Position

The primary responsibility of this role is to provide biomarker technical expertise and support to the Translational Science Lead (TSL) to ensure operational implementation and execution of translational science 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 TSL 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.

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
Applies Bayer’s VACC leadership behaviors
Demonstrates high self-awareness as well as system awareness
Pro-actively asks for and gives feedback
Focuses on outcomes: defines and deliver highest pipeline, team, talent, and organizational impact outcomes
Collaborates with accountability: collaborates and holds each other accountable in and across teams
Co-creates for customers: is close to the customer and co-creates solutions for their needs
Acts, learns fast and evolves: works in 90-days cycles, applies learnings fast and continually develops
Is the best self and includes others: respects differences, embraces inclusion and shows up as the best self.

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, 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.