Director, Clinical Biomarker Operations- Translational Sciences- Immunology

Job Description

Johnson & 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 if approved by the company.

• 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, overseeing 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.

• 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.

• Competitive salary and annual performance bonus.
• Medical, dental, vision, and life insurance; short- and long-term disability; group legal insurance.
• 401(k) retirement plan.
• Long‑term incentive program.
• Paid time off: up to 120 hours of vacation, up to 40 hours of sick time (56 hours in Washington State), up to 13 days of holiday pay including floating holidays, and up to 40 hours of work, personal and family time.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.