Associate Director, Clinical Biomarker Operations-Translational Sciences-Immunology

Johnson & Johnson Innovative Medicine•San Diego, CA

18h•$137,000 - $238,050•Hybrid

About The Position

The Associate Director, Clinical Biomarker Operations provides operational leadership for executing clinical biomarker plans across late-stage development programs. The role translates biomarker strategy into fit-for-purpose operational plans and ensures timely, compliant, high-quality delivery of biospecimen collection, laboratory testing, and biomarker data. It manages external laboratory partners, influences cross-functional decisions, and advances scalable processes and standards for clinical biomarker operations. The position is part of Immunology Translational Sciences and Medicine, an integrated organization connecting Discovery Research with later-phase Clinical Development. The team applies clinical data, scientific insights, biomarker development, disease biology, immunology, and data science technologies to support drug discovery and development and address unmet needs in immune-mediated diseases. The role is based in Spring House, Pennsylvania; La Jolla, California; or Cambridge, Massachusetts. It may involve approximately 10% domestic and international travel based on business needs, and may include direct supervision or matrix leadership.

Requirements

At least 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, 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.
Ability to lead complex projects, prioritize competing demands, make risk-based decisions, and deliver high-quality outcomes in a dynamic environment.
Strong vendor management, negotiation, financial management, and issue-resolution skills.
Strategic thinking and ability to connect scientific objectives to practical operational solutions.
Excellent written and verbal communication skills, including influencing cross-functional stakeholders and presenting recommendations to leadership.
Collaborative leadership style and effectiveness in global, cross-functional, and matrixed teams.
High attention to detail, sound judgment, learning agility, and 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

Advanced degree in life sciences, biomedical sciences, pharmacy, medicine, or a related discipline; a bachelor’s degree with substantial relevant experience may be considered.
Prior people leadership, matrix leadership, mentoring, or functional leadership experience.
Experience in immunology and inflammation, oncology, or another biomarker-intensive therapeutic area.

Responsibilities

Lead 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.
Oversee the biospecimen lifecycle, including collection, processing, shipment, storage, reconciliation, testing, and final disposition, consistent 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 align assay readiness, testing capacity, sample availability, and data delivery with program milestones.
Collaborate with Clinical Operations, Translational Science, Data Management, Procurement, Quality, Regulatory, Clinical Development, regional teams, and other functions to integrate biomarker deliverables into study execution.
Establish and oversee sample- and data-tracking processes; monitor key performance indicators, investigate discrepancies, and drive timely corrective and preventive actions.
Identify operational, quality, regulatory, budget, and timeline risks; develop mitigation plans and escalate issues with options and recommendations.
Ensure compliance 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, traceable biomarker operations documentation and coordinating responses with internal and external partners.
Drive process improvement and operational excellence, including the 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 potentially provide direct or matrix leadership to biomarker operations professionals, fostering accountability, collaboration, inclusion, and continuous learning.

Benefits

Annual performance bonus, subject to the applicable plan and company discretion.
Medical, dental, and vision insurance.
Life insurance and short- and long-term disability coverage.
Business accident insurance and group legal insurance.
Eligibility to participate in the consolidated retirement plan (pension) and savings plan (401(k)).
Eligibility to participate in the long-term incentive program.
Vacation of up to 120 hours per calendar year.
Sick time of up to 40 hours per calendar year; Washington residents may receive up to 56 hours per calendar year.
Holiday pay, including floating holidays, of up to 13 days per calendar year.
Work, Personal and Family Time of up to 40 hours per calendar year.