Director, Clinical Biomarker Operations- Translational Sciences- Immunology

Director, Clinical Biomarker Operations

Johnson and Johnson is recruiting for a Director, Clinical Biomarker Operations to be located in Spring House, PA, Cambridge, MA, or La Jolla, CA. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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.

This position resides within the Immunology Translational Sciences group and requires a highly motivated, skilled and proactive candidate to drive the translational research for innovative therapies across immune-mediated diseases. The Director, Clinical Biomarker Operations will lead the Immunology biomarker operations function within Translational Science. This role is accountable for establishing and executing a centralized, scalable, and high‑quality clinical biomarker operations model to support Immunology clinical programs across early and late development. The successful candidate will be single point of accountability for clinical biomarker operational execution in Immunology, shape the overall strategy for clinical biomarker execution, and lead a team of biomarker operations professionals. The role will bridge science and operations through cross-functional partnerships, strategic project planning, and driving key initiatives and decisions on clinical biomarker execution.

Responsibilities are as follows:

• Define and drive the biomarker operations strategy for Immunology Translational Science, including definition of roles, responsibilities, and ways of working,
• Establish, implement, and maintain standardized biomarker operations processes and SOPs to ensure consistent execution across programs
• Provide operational leadership across early and late‑stage Immunology clinical programs, overseeing biomarker plans, timelines, budgets, risks, and quality metrics
• Provide expert biomarker and diagnostic development input into required clinical documents such as protocols, ICF, IB, and lab manuals; Ensure end‑to‑end execution of biospecimen collection, testing, and data delivery to meet clinical development needs
• Ensure compliance with global regulatory requirements, ICH GCP, GLP, and quality standards for biomarker and diagnostic deliverables
• Shape and lead biomarker vendor strategy, setup, and lifecycle management for Immunology studies, oversee vendor selection and performance management in partnership with Procurement and scientific stakeholders
• Drive continuous improvement in efficiency, quality, and scalability of clinical biomarker operations
• Identify and foster critical collaborations with strategic partners, vendors, and external collaborators; Evaluate, select, and develop strategic partnerships to position the organization for future business needs
• Develop and maintain strong relationships with internal and external stakeholders; Communicate progress, challenges, and changes that may impact timelines to leadership
• Serve as the single point of accountability for biomarker operational execution within Immunology Translational Science
• Lead, mentor, and develop the Immunology biomarker operations team, setting clear expectations and fostering a high‑performing culture; Establish internal working groups to develop best practices and operational solutions.

Qualifications

• Advanced degree in Life Sciences, Biomedical Sciences, Medicine, or related discipline
• 8+ years of experience in clinical biomarker operations within pharmaceutical or biotechnology R&D, with 3+ years in a leadership role
• Demonstrated people leadership skills in a matrixed environment and cross‑functional influencing experience
• Extensive hands-on experience with compliance/oversight of operationalizing clinical biomarker assays, contracting service laboratories, and biosample tracking systems.
• Proven ability to build and scale SOP‑driven operational models and to effectively prioritize, organize, and lead cross-functional projects
• Strong knowledge and understanding of clinical research, ICH GCP, GLP; Familiarity with global health authority interactions
• Proven track record of evaluating, selecting, and developing strategic partnerships with vendors and external collaborators
• Experience supporting Immunology clinical programs strongly preferred
• Direct people management experience strongly preferred.

The anticipated base pay range for this position is: $160,000 - $276,000

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.