Biomarker Technical Expert

Bayer AG; Cambridge (MA); On-site; USD 116,000 - 193,000; Full time

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer AG is seeking a Biomarker Technical Expert to provide biomarker technical expertise and support to ensure translational science strategies are effectively implemented in clinical trials across oncology programs.

The role covers biomarker operations, data management collaboration, lab vendor management, and coordination with external partners to ensure timely and quality data delivery in line with GCP/ICH guidelines.

Qualifications

• Extensive pharmaceutical industry experience and in-depth knowledge of clinical drug development.
• Clinical laboratory experience including processing/analysis of clinical samples.
• Strong project management and organizational skills.
• Excellent critical reasoning and problem-solving abilities.
• Detail oriented with the ability to work independently and manage multiple priorities.
• Proven leadership in multi-cultural, geographically diverse teams.

Responsibilities

• Collaborate with translational science leaders and cross-functional teams to support translational strategies in clinical trials.
• Develop operational input for study documentation and ensure biomarker sample collection, delivery and analysis in line with GCP/ICH.
• Serve as single point of contact for biomarker operations across functions and with CROs.
• Provide biomarker operations guidance to study teams and drive process improvements.
• Coordinate biomarker data format, timelines and data transfer with data management and CDx partners.
• Oversee lab vendor management, data QC and timely reporting of results.

Skills

Clinical drug development

Laboratory analysis

Project management

Critical reasoning

Attention to detail

Cross-cultural collaboration

Education

Bachelor's degree with 5+ years

Doctoral degree with 3+ years

Master's degree with 5+ years

Job description

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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

• 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:

• 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;
• 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;

Preferred Qualifications:

• 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.

Employees can expect to be paid a salary between $128,480.00 - $192,720.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.

This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 09/02/2026.

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