Biomarker Technical Expert

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

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.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Biomarker Technical Expert are to:

* 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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

* Bachelor's degree;

* Extensive pharmaceutical industry experience and in-depth knowledge of clinical drug development;

* Clinical laboratory experience…