Scientific Director, Global Diagnostic Lead, Oncology Precision Medicine Diagnostics

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:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America, US337 MA Cambridge - 301 Binney St

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

We are searching for the best talent for a Scientific Director, Global Diagnostic Lead, Oncology Precision Medicine Diagnostics to be located in Spring House, PA, Raritan, NJ, Cambridge, MA, San Diego, CA.

We are seeking a highly motivated individual to join the Oncology Precision Medicine Diagnostics team. As a Scientific Director-Oncology Companion Diagnostics, you will develop end-to-end diagnostic strategy in collaboration with key stakeholders and ensure that the diagnostic strategy is in alignment with the development plan and with timelines for registration of the pharmaceutical asset.

Responsibilities Include:

• Develop and lead the global diagnostic strategy across all assets within Heme, ensuring alignment with overall clinical development and regulatory activities.
• Serve as the primary point of accountability for diagnostic strategy, execution, and registration activities in support of early and late-stage drug development programs.
• Interact early development and Translational Research to understand the predictive hypotheses to be tested for specific programs. Collaborate with internal research capabilities to develop a predictive assay if not already available.
• Collaborate with Translational Research and with Clinical development teams to design studies to test the clinical utility of the companion diagnostic.
• Understand CLIA-laboratory, FDA testing guidelines and assay validation requirements.
• Select diagnostic partner to deliver potential companion diagnostic assays in time for pharmaceutical registration.
• Manage relationships with contract laboratories and companion diagnostic partners including ensuring in-stream data quality from partners.
• Work with colleagues in Regulatory Affairs to ensure that all relevant regulatory documents (e.g. IDEs, PMAs, etc.) are delivered and communicate with regulatory authorities when required.
• Regularly communicates updates to, and seeks feedback from, Clinical Teams, Compound Development Teams, and other stakeholders where appropriate, surrounding progress of the companion diagnostic program.
• Supervise personnel to deliver companion diagnostic programs to enable registration of pharmaceuticals.
• Keep current with novel technologies that have imp