Director, Clinical Biomarker Operations- Translational Sciences- Immunology

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Translational Discovery & Development Biomarkers

Job Category:

People Leader

All Job Posting Locations:

San Diego California United States of America Spring House Pennsylvania United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at Immunology

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at 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 thekey 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 highquality 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 latestage 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 endtoend 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 highperforming 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 crossfunctional 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 SOPdriven 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: $160000 - $276000

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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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. 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.

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.

Required Skills:

Preferred Skills:

Biomarkers Business Savvy Clinical Trials Operations Developing Others Drug Discovery Development Inclusive Leadership Industry Analysis Interdisciplinary Work Leadership Medical Compliance Medical Technology Organizational Project Management Product Development Quality Standards Scientific Research Stakeholder Management Technologically Savvy Translational Medicine

The anticipated base pay range for this position is :

$164000.00 - $282900.00

Additional Description for Pay Transparency: