Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Translational Discovery & Development Biomarkers

Job Category:
Scientific/Technology

All Job Posting Locations:
Cambridge, Massachusetts, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for a Associate Director, Clinical Biomarker Operations, Translational Science-Immunology, to be in Spring House, PA, La Jolla, CA or Cambridge, MA.

Immunology Translational Sciences and Medicine (TSM) is an integrated group of scientists composed of a clinical Translational Medicine (TM) team which conducts early clinical development and experimental medicine studies, and a Translational Sciences (TS) team which uses clinical data and scientific insights to support the end-to-end portfolio. Together, the TSM group will provide the key learnings/insights on the next wave of novel therapies for these patients. Organizationally, TSM serves as a pivotal bridge between Discovery Research and the later phase Clinical Development group. TSM provides the necessary scientific and clinical expertise to advance an industry-leading pipeline of novel mechanism small molecules and biologic agents to address unmet need in immune-mediated diseases.

TS has a broad remit stretching from support of discovery with human data to support target selection, through development of novel decision-making biomarkers for early phase clinical trials, target-centric indication sequencing and prioritization, and biomarker support of regulatory filings. It has expertise in biomarker development, disease biology research and in the application of immunology and data science technologies to support drug discovery and development.

The Associate Director, Clinical Biomarker Operations provides strategic and operational leadership for the execution of clinical biomarker and diagnostic plans across early- and 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 leads complex studies and programs, manages external laboratory partners, influences cross-functional decisions, and helps advance scalable processes and standards for clinical biomarker operations.

Responsibilities are as follows:

• Lead the operational planning and execution of clinical biomarker and diagnostic strategies across multiple complex studies or development programs.
• Develop and maintain integrated biomarker operational plans, timelines, budgets, 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.

Principal Relationships

Internal: Translational Science, Clinical Development, Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Quality, Procurement, Legal, Finance, Clinical Pharmacology, Medical Writing, regional organizations, and other scientific and operational functions.

External: Central laboratories, specialty and bioanalytical laboratories, contract research organizations, technology providers, consultants, and other strategic partners.

Qualifications

• 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.
• 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.

Required Knowledge, Skills, and Capabilities

• 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.
• 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.

Additional Information

• May require approximately 10% domestic and international travel, based on business needs.
• May supervise direct reports or provide matrix leadership across programs and initiatives.
• This description is not an exhaustive listing of duties; additional responsibilities may be assigned based on business priorities.

The anticipated base pay range for this position is: $139,000 - $238,050

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company's long-term incentive program.
• Employees are eligible for the following time off benefits:
• 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 of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

#LI-Hybrid

Required Skills:

Preferred Skills:
Biomarkers, Clinical Trials Operations, Controls Compliance, Drug Discovery Development, Industry Analysis, Interdisciplinary Work, Medical Compliance, Medical Technology, Organizational Project Management, Program Management, Quality Standards, Safety-Oriented, Scientific Research, Tactical Planning, Technical Credibility, Technologically Savvy, Translational Medicine

The anticipated base pay range for this position is :
$137,000.00 - $235,750.00

Additional Description for Pay Transparency: