Senior Manager, Global Diagnostics Lead- Oncology Precision Medicine Diagnostics

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:

Scientific/Technology

All Job Posting Locations:

Raritan New Jersey United States of America Spring House Pennsylvania United States of America Titusville New Jersey 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 Oncology

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 Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to find treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

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 are searching for the best talent for a Senior Manager Global Diagnostic Lead Oncology Precision Medicine Diagnostics to be located in Springhouse PA Titusville PA Raritan NJ Cambridge MA San Diego CA.

We are seeking a highly motivated individual to join the Oncology Precision Medicine Diagnostics team. The Senior Manager Global Diagnostic Lead will contribute to the development and execution of diagnostic strategies supporting oncology drug development programs. Working in close partnership with a more senior Diagnostic Lead and cross-functional stakeholders this individual will independently lead one or more defined diagnostic programs or major workstreams from biomarker hypothesis through clinical testing assay validation and where applicable companion diagnostic development.

This is a developmental Global Diagnostic Lead opportunity for an individual who has established experience in oncology biomarkers clinical assay development in vitro diagnostics clinical laboratory testing or companion diagnostics and has begun to demonstrate diagnostic leadership. The role will provide increasing accountability for diagnostic strategy and execution while maintaining senior oversight for consequential regulatory partner-selection investment and portfolio-level decisions.

Responsibilities Include:

Diagnostic Strategy and Program Leadership

• Contribute to the development of end-to-end diagnostic strategies aligned with the clinical development plan regulatory strategy and anticipated pharmaceutical registration timelines.
• Independently lead one or more defined diagnostic programs or major workstreams with strategic guidance and oversight from an Associate Director Director or Scientific Director.
• Translate clinical and translational biomarker objectives into actionable diagnostic development plans timelines risks decision points and deliverables.
• Serve as the day-to-day diagnostic point of contact for assigned program teams and communicate progress decisions risks and recommendations to appropriate stakeholders.
• Make recommendations within the assigned scope and promptly escalate significant strategic regulatory quality budget partner or timeline decisions to senior diagnostic leadership.
• Provide diagnostic input into clinical protocols biomarker plans sample strategies and integrated development plans.

Cross-Functional Leadership

• Collaborate with Translational Research Clinical Development Regulatory Affairs Biostatistics Clinical Operations Commercial and other relevant functions to execute the diagnostic strategy.
• Lead cross-functional diagnostic workstreams and influence without direct authority to drive alignment accountability and timely delivery.
• Partner with Translational Research and Clinical Development colleagues to design studies evaluating analytical performance clinical performance clinical utility patient selection disease monitoring measurable residual disease or molecular response as applicable.
• Facilitate cross-functional diagnostic discussions document decisions and actions and drive follow-through on agreed deliverables.

Assay and Clinical Testing Oversight

• Support identification and selection of fit-for-purpose assay technologies contract laboratories and diagnostic development partners.
• Manage assay development transfer optimization verification and validation activities for assigned programs.
• Work with internal subject matter experts to evaluate assay performance and confirm that validation plans are appropriate for the assay intended use.
• Develop or contribute to analytical validation requirements for exploratory clinical trial investigational or companion diagnostic assays.
• Oversee assigned clinical sample-testing activities and monitor testing quality data delivery timelines and operational performance.
• Partner with clinical and operational teams to identify and resolve sample availability sample quality testing capacity data-transfer and related execution issues.

External Partner Management

• Lead and be accountable for the end-to-end execution of assigned diagnostic projects coordinating contract laboratories diagnostic partners and cross-functional stakeholders to deliver against agreed objectives timelines and milestones.
• Contribute to technical evaluations requests for information feasibility assessments scopes of work budgets and partner-selection recommendations.
• Monitor partner performance and escalate issues that could affect data quality clinical timelines regulatory deliverables or pharmaceutical registration.
• Support senior Diagnostic Leads in strategic partner selection negotiations contracting discussions and governance interactions.

Regulatory and Quality Support

• Apply working knowledge of CLIA CAP FDA and relevant global diagnostic requirements to assigned clinical assay and diagnostic activities.
• Collaborate with Regulatory Affairs and diagnostic subject matter experts to support preparation of regulatory documentation.
• Contribute diagnostic content to briefing documents investigational submissions responses to health-authority questions and other regulatory deliverables.
• Participate in health-authority preparation and interactions as appropriate with support from senior diagnostic and regulatory colleagues.
• Maintain documentation and decision records consistent with applicable quality systems and program governance expectations.
• Maintain awareness of evolving United States and global regulatory expectations for oncology biomarkers clinical assays and companion diagnostics.

Scientific and Technical Leadership

• Maintain current knowledge of oncology biomarkers diagnostic technologies assay platforms regulatory developments and industry trends.
• Evaluate emerging technologies and provide recommendations regarding their potential application to assigned development programs.
• Contribute to selection of diagnostic methodologies based on intended use analytical performance clinical requirements sample availability development timelines and regulatory considerations.
• Present diagnostic plans results risks and recommendations to cross-functional program teams and governance forums.
• Contribute to a collaborative team environment and share technical knowledge and best practices across the Oncology Precision Medicine Diagnostics organization.

Qualifications - External

Required Qualifications

• PhD in molecular biology biochemistry genetics immunology pathology biomedical sciences or another relevant scientific discipline with a minimum of 3 years of relevant industry experience; or a Masters degree in a relevant scientific discipline with a minimum of 6 years of relevant industry experience.
• Relevant pharmaceutical biotechnology diagnostics medical-device or clinical-laboratory experience in one or more of the following: oncology biomarker development clinical assay development or validation in vitro diagnostic development companion diagnostic development clinical laboratory testing or translational medicine.
• Working knowledge of assay development and validation principles including the relationship between an assays intended use and analytical performance requirements.
• Experience contributing to cross-functional drug-development biomarker clinical-testing or diagnostic programs.
• Demonstrated experience leading at least one diagnostic biomarker assay-development assay-validation clinical-testing or external-partner workstream.
• Experience supporting biomarkers or diagnostics in early or late clinical development.
• Experience coordinating activities with contract laboratories diagnostic companies technology providers or other external partners.
• Strong project-management skills including the ability to manage timelines dependencies risks decisions and deliverables.
• Strong written and verbal communication skills with the ability to communicate scientific and technical information to multidisciplinary stakeholders.
• Demonstrated ability to lead cross-functional teams and influence without direct authority in a highly matrixed collaborative and global environment.

Preferred Qualifications

• One to two years of experience serving in a diagnostic leadership or comparable workstream-lead role such as Diagnostic Lead deputy or supporting Diagnostic Lead diagnostic subteam lead biomarker lead assay-development or validation lead clinical-testing lead or laboratory or diagnostic-partner lead.
• Experience supporting oncology biomarker or diagnostic development is preferred. Experience in hematologic oncology is a plus but not required.
• Experience spanning more than one stage of clinical oncology development.
• Experience supporting clinical trial assays used for patient selection treatment assignment efficacy endpoints disease monitoring measurable residual disease or molecular response assessment.
• Exposure to companion diagnostic development models including kit-based and single-site laboratory approaches.
• Experience reviewing or contributing to assay-validation plans clinical study documents regulatory submissions or health-authority responses. Prior ownership of a regulatory submission is not required.
• Working familiarity with United States and global diagnostic regulatory requirements.
• Experience working with clinical samples and associated sample-management data-quality or testing-operational considerations.

The anticipated base pay range for this position is: $137000 - $235750

The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position may be eligible for an annual performance bonus in accordance with the terms of the applicable plan. Compensation and benefit details should be confirmed and inserted by Human Resources for the approved location and job grade.

• Employees and/or eligible dependents may be eligible to participate in Company-sponsored employee benefit programs.
• Employees may be eligible to participate in applicable retirement and savings plans.
• Employees may be eligible for applicable time-off benefits.

Additional information can be found at compensation and benefits information included in the final posting should reflect the requirements applicable to the approved hiring location.

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 applicable law.

Johnson & Johnson is committed to providing an interview process that is inclusive of applicants needs. Human Resources should confirm the current accommodation language and contact information before posting.

#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 :

$137000.00 - $235750.00

Additional Description for Pay Transparency: