Biomarker Operations Leader (Translational Science)

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

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.