Senior Director, Global Head Biomarker & Diagnostic Operations-Oncology

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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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 finding 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 Senior Director Global Head Biomarker & Diagnostic Operations will lead the global strategy execution and operational excellence of biomarker and diagnostic activities across early and late-stage clinical development with a focus on precision medicine. This role is responsible for driving innovation operational frameworks and strategic partnerships within Oncology R&D. The position oversees global teams and collaborates cross-functionally to deliver impactful biomarker and diagnostic solutions that improve patient outcomes.

We are searching for the best talent for a Senior Director Global Head Biomarker & Diagnostic Operations-Oncology role. You will be responsible for:

• Strategic Leadership
  • Define and implement global biomarker and diagnostic operations strategy aligned with portfolio priorities and precision medicine objectives.
  • Drive operational frameworks for biomarker assay development validation and deployment in clinical trials.
  • Lead global cross-functional teams to integrate biomarker strategies into clinical programs.
• Operational Excellence
  • Oversee and coordinate all operational aspects of early biomarker development and companion diagnostic implementation in clinical trials for assigned programs.
  • Ensure compliance with global regulatory requirements ICH GCP GLP and quality standards for biomarker and diagnostic deliverables.
  • Provide direction and oversight of biomarker & diagnostic assay work performed at external CROs and service laboratories.
  • Working with both internal and external stakeholders to ensure data delivery is on-time to support project requirements and R&D innovation
  • Proactively identify trends and develop/implement solutions to maintain operational excellence.
• Partnerships & Collaboration
  • 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.
  • Effectively influence across global teams and within a highly matrixed environment.
• Team Leadership & Development
  • Recruit manage and provide leadership and strategic direction for the global diagnostic operations team.
  • Establish internal working groups to develop best practices and operational solutions.
  • Foster a culture of accountability innovation and continuous improvement.
• Budget & Resource Management
  • Responsible for high level oversight of biomarker timelines budgets resources and vendors for key programs and project deliverables.
  • Works closely with J&J Procurement Legal and Business Development to structure and execute strategic biomarker and Dx master and partnership agreements.
• Stakeholder Engagement
  • Develop and maintain strong relationships with internal and external stakeholders.
  • Provide expert biomarker and diagnostic development input into required clinical documents such as protocols ICF IB and lab manuals.
  • Communicate progress challenges and changes that may impact timelines to senior leadership.

Qualifications and Preferred Experience

• PhD MD PharmD or Masters degree in a scientific discipline (Life Sciences Molecular Biology or related field).
• 12 years of experience in pharmaceutical and drug development with at least 5 years in a senior leadership role.
• Oncology and precision medicine expertise.
• Extensive hands-on experience with compliance/oversight of operationalizing biomarker and diagnostic assays contracting service laboratories and biosample tracking systems.
• Experience with digital biomarkers and emerging diagnostic technologies.
• Familiarity with global health authority interactions and submissions for companion diagnostics.
• Proven ability to influence effectively across global teams and within a highly matrixed environment.
• Strong knowledge and understanding of clinical research ICH GCP GLP.
• Proven track record of evaluating selecting and developing strategic partnerships with vendors and external collaborators.
• 5 years of line management experience.
• Proven ability to effectively prioritize organize and lead cross-functional projects.

The anticipated base pay range for this position is $196000 to $322000.

Subject to the terms of their respective plans employees are 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.

Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 13 days per calendar year

Work Personal and Family Time - up to 40 hours per calendar year

Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

Condolence Leave 30 days for an immediate family member: 5 days for an extended family member

Caregiver Leave 10 days

Volunteer Leave 4 days

Military Spouse Time-Off 80 hours

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.

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