Distinguished Global Translational Biomarker Lead

Johnson & Johnson - Spring House, PA

Full-time - Senior

Spring House, PA

Chemical Manufacturing

About the position

The Distinguished Global Translational Biomarker Lead at Johnson & Johnson is a senior-level role focused on establishing a new center for translational biomarker innovation. This position involves leading a team of medical laboratory and biomarker scientists to develop and execute translational safety biomarker strategies across various therapeutic areas. The role requires a strong background in clinical pathology and translational safety biomarker development, with responsibilities that include overseeing laboratory operations, ensuring compliance, and driving strategic initiatives aimed at improving biomarker support and process efficiency.

Responsibilities

• Establish and lead a central laboratory focused on translational biomarker development and innovation.
• Accountable for the execution of analytical strategies including routine clinical pathology and non-routine biomarkers.
• Coordinate deliverables with diverse stakeholders across Pathobiology and PSTS.
• Design, develop, implement, and execute fit-for-purpose assays and validation reports.
• Oversee all laboratory operations, ensuring scientific rigor and timely delivery.
• Maintain Standard Operating Procedures (SOPs) pertaining to laboratory operations.
• Execute the strategic translational safety biomarker vision and lead CPSB strategic initiatives.
• Drive the development and application of innovative platforms and assays for improving Translational Safety Biomarker support.
• Develop comprehensive translational safety biomarker strategies for risk assessment and mitigation.
• Collaborate with Target Clinical Pathologists and Immunotoxicologists on biomarker selection and assay methodology.
• Provide SME consultation to PSTS teams and external stakeholders for human risk assessments.
• Serve as a subject matter expert in responses to health authority queries and regulatory submissions.
• Participate in issue management/resolution teams and provide functional leadership.
• Build partnerships with internal R&D leaders and the external scientific community.

Requirements

• Doctoral degree in Veterinary Medicine or related field (D.V.M. or Ph.D.)
• Current ACVP board certification in clinical pathology
• 10 years of experience in clinical pathology and translational safety biomarker development
• Strong data analysis skills and laboratory experience
• Expertise in immunoassays and bioinformatics
• Excellent communication skills and ability to work in a diverse team
• Hands-on knowledge of Laboratory Information Management Systems (LIMS)
• Demonstrated competence in clinical pathology including hematology, coagulation, clinical chemistry, and urinalysis

Nice-to-haves

• Experience with specialized medical diagnostics and biomarkers
• Familiarity with regulatory submission processes
• Experience in mentoring and collaborative leadership
• Publications in high-quality journals and presentations at conferences

Benefits

• Competitive salary
• Health insurance
• 401k retirement plan
• Paid time off
• Professional development opportunities