Senior Director, Global Head Biomarker & Diagnostic Operations-Oncology

Johnson & Johnson•Spring House, PA

29d

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Translational Discovery & Development Biomarkers Job Category: People Leader All Job Posting Locations: Cambridge, Massachusetts, 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 https://www.jnj.com/innovative-medicine About 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 https://www.jnj.com/innovative-medicine The 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.

Requirements

PhD, MD, PharmD, or Master’s 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.
Strong knowledge and understanding of clinical research, ICH GCP, GLP.
Proven ability to effectively prioritize, organize, and lead cross-functional projects.

Nice To Haves

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.
Proven track record of evaluating, selecting, and developing strategic partnerships with vendors and external collaborators.
5+ years of line management experience.

Responsibilities

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.

Benefits

Subject to the terms of their respective plans, employees are 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.
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