Clinical Biomarker Operations Leader

Johnson & Johnson Innovative Medicine; San Diego (CA); On-site; USD 139,000 - 238,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid vacation

Job summary

Johnson & Johnson Innovative Medicine is seeking an Associate Director, Clinical Biomarker Operations to lead biomarker plans across late‑stage trials. You will supervise biospecimen handling, biomarker testing, and data delivery, coordinating with Clinical Operations and outside labs to meet program milestones.

You will mentor teams, manage vendor relationships, and ensure compliance with ICH/GCP standards while driving process improvements in biomarker operations.

Qualifications

• Advanced degree in life sciences preferred; a bachelor’s degree with substantial relevant experience may be considered.
• 8+ years of relevant experience in pharmaceutical/biotech biomarker operations.
• Experience leading clinical biomarker operations for global, multi‑vendor studies across the drug development lifecycle.
• Experience managing budgets, contracts, statements of work, timelines, risks, and vendor performance.
• Prior people leadership or matrix leadership experience is preferred.

Responsibilities

• Lead operational planning and execution of clinical biomarker strategies across complex studies.
• Develop integrated biomarker plans, timelines, budgets, and risk assessments from start‑up to closeout.
• Oversee biospecimen collection, processing, shipment, storage, testing, and data delivery per protocols.
• Provide biomarker operations input to protocols, ICFs, and study documents.
• Lead central and specialty lab strategy, vendor evaluation, contracting, onboarding, and performance oversight.
• Collaborate with Clinical Operations, Translational Science, Data Management, and regions to integrate biomarker deliverables.

Skills

Biomarker operations

Clinical biomarker strategy

Vendor management

Cross-functional leadership

Budget management

Education

Advanced degree in life sciences

Tools

Laboratory information systems

Job description

Johnson & Johnson Innovative Medicine is seeking an Associate Director, Clinical Biomarker Operations to lead biomarker plans across late‑stage trials. You will supervise biospecimen handling, biomarker testing, and data delivery, coordinating with Clinical Operations and outside labs to meet program milestones.

You will mentor teams, manage vendor relationships, and ensure compliance with ICH/GCP standards while driving process improvements in biomarker operations.