Associate Director, Clinical Biomarker Operations-Translational Sciences-Immunology (Immunology)

Location: Hybrid role based in Spring House, Pennsylvania; La Jolla, California; or Cambridge, Massachusetts, United States. Approximately 10% domestic and international travel may be required.

Base pay: $139,000–$238,050 annually.

Company

Johnson & Johnson MedTech develops healthcare innovations and medicines across discovery, clinical development, and medical technology.

What you will do

• Lead operational planning and execution for clinical biomarker and diagnostic strategies across complex studies and development programs.
• Build and maintain integrated plans covering timelines, budgets, risks, quality metrics, and resources from study start-up through closeout.
• Oversee the end-to-end biospecimen lifecycle, including collection, processing, shipment, storage, reconciliation, testing, and disposition.
• Lead central and specialty laboratory strategy, including vendor selection, qualification, contracting, performance oversight, and issue resolution.
• Partner with scientific, clinical, data, regulatory, quality, procurement, and regional teams to deliver biomarker milestones.
• Drive inspection readiness, corrective actions, process improvements, standards, training, and technology-enabled workflows.

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.
• At least 8 years of relevant experience in pharmaceutical, biotechnology, CRO, central laboratory, clinical research, biomarker, diagnostic, or translational science operations.
• 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 and diagnostic 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.

Nice to have

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

Culture & Benefits

• Collaborative, inclusive, cross-functional, and matrixed working environment.
• Medical, dental, vision, life insurance, disability, accident, and legal insurance programs may be available.
• Retirement pension and 401(k) savings plans may be available.
• Performance bonus and long-term incentive program eligibility.
• Vacation, sick time, holiday pay, and personal and family time benefits.