Associate Director, Clinical Biomarker Operations-Translational Sciences-Immunology

Johnson & Johnson Innovative Medicine • San Diego, CA

4d • $139,000 - $238,050 • Hybrid

About The Position

The Associate Director, Clinical Biomarker Operations provides operational leadership for the execution of clinical biomarker plans across late-stage development programs. This role is accountable for translating biomarker strategy into fit-for-purpose operational plans and ensuring the timely, compliant, and high-quality delivery of biospecimen collection, laboratory testing, and biomarker data. The Associate Director manages external laboratory partners, influences cross-functional decisions, and helps advance scalable processes and standards for clinical biomarker operations.

Requirements

• Advanced degree in life sciences, biomedical sciences, pharmacy, medicine, or a related discipline preferred; a bachelor’s degree with substantial relevant experience may be considered.
• 8+ years of relevant experience in pharmaceutical, biotechnology, CRO, central laboratory, clinical research, biomarker, diagnostic, or translational science operations.
• Demonstrated experience leading clinical biomarker operations for complex, global, and multi-vendor studies across the drug development lifecycle.
• Experience managing budgets, contracts, statements of work, timelines, risks, and vendor performance.
• Strong knowledge of clinical development, biomarker operations, biospecimen lifecycle management, laboratory processes, and biomarker data flow.
• Working knowledge of ICH GCP, applicable GLP principles, informed consent, data integrity, privacy, and global regulatory and quality expectations.
• Proven ability to lead complex projects, prioritize competing demands, make risk-based decisions, and deliver high-quality outcomes in a dynamic environment.
• Excellent vendor management, negotiation, financial management, and issue-resolution skills.
• Strong strategic thinking with the ability to connect scientific objectives to practical operational solutions.
• Excellent written and verbal communication skills, including the ability to influence cross-functional stakeholders and present recommendations to leadership.
• Collaborative leadership style and demonstrated effectiveness in global, cross-functional, and matrixed teams.
• High attention to detail, sound judgment, learning agility, and a commitment to quality, ethics, and patient-focused execution.
• Proficiency with standard business applications and familiarity with clinical sample tracking, laboratory information, document management, and data visualization systems.

Nice To Haves

• Prior people leadership, matrix leadership, mentoring, or functional leadership experience preferred.
• Experience in immunology and inflammation, oncology, or another biomarker-intensive therapeutic area is preferred.

Responsibilities

• Lead the operational planning and execution of clinical biomarker strategies across multiple complex studies or development programs.
• Develop and maintain integrated biomarker operational plans, timelines, budget tracking, risk assessments, quality metrics, and resource forecasts from study start-up through closeout.
• Ensure end-to-end oversight of biospecimen collection, processing, shipment, storage, reconciliation, testing, and final disposition in accordance with protocols, informed consent, laboratory manuals, and applicable requirements.
• Provide biomarker operations input to clinical protocols, informed consent forms, laboratory manuals, sample management plans, investigator materials, data transfer specifications, and other study documents.
• Lead central and specialty laboratory strategy, including vendor evaluation, selection, qualification, contracting, onboarding, performance oversight, issue resolution, and closeout.
• Partner with scientific leads to operationalize fit-for-purpose biomarker assays and ensure assay readiness, testing capacity, sample availability, and data delivery align with program milestones.
• Collaborate with Clinical Operations, Translational Science, Data Management, Procurement, Quality, Regulatory, Clinical Development, and regional teams to integrate biomarker deliverables into clinical study execution.
• Establish and oversee sample- and data-tracking processes; monitor key performance indicators, investigate discrepancies, and drive timely corrective and preventive actions.
• Proactively identify operational, quality, regulatory, budget, and timeline risks; develop mitigation plans and escalate issues with clear options and recommendations.
• Ensure activities comply with company procedures, ICH GCP, applicable GLP principles, privacy requirements, ethical standards, and local and global regulatory expectations.
• Support inspection and audit readiness by maintaining complete, accurate, and traceable biomarker operations documentation and by coordinating responses with internal and external partners.
• Drive process improvement and operational excellence initiatives, including development of standards, templates, guidance, training, and technology-enabled workflows.
• Represent Clinical Biomarker Operations on cross-functional study and program teams and communicate status, risks, decisions, and recommendations to stakeholders and leadership.
• Mentor colleagues and may provide direct or matrix leadership to biomarker operations professionals, fostering accountability, collaboration, inclusion, and continuous learning.

Benefits

• medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• consolidated retirement plan (pension) and savings plan (401(k)).
• long-term incentive program.
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree