Johnson & Johnson Innovative Medicine
Scientific Director, Global Diagnostic Lead, Oncology Precision Medicine Diagnos
Johnson & Johnson Innovative Medicine, Raritan, New Jersey, us, 08869
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
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 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
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 impact on oncology diagnostic testing.
Aid in selection of diagnostic assay methodologies. Maintain familiarity with relevant regulatory requirements both within the US and abroad.
Qualifications
Master’s Degree in a relevant scientific discipline (e.g., molecular biology, biochemistry or related field) is required; PhD Degree strongly preferred
Minimum of 7-10 years of industry experience in companion diagnostics (CDx) development and in vitro assay development is required.
10+ years of experience in diagnostic strategy and/or clinical biomarker development, including track record of successful regulatory submissions, is strongly preferred.
Demonstrated expertise in Oncology diagnostics with Hematologic malignancy experience is strongly preferred
Deep understanding of regulatory and clinical requirements for diagnostics development and commercialization, including global regulatory frameworks (e.g., FDA, EMEA, PMDA).
Proven ability to lead cross functional teams and manage external diagnostics partnerships across global programs.
Excellent communication and stakeholder engagement skills, with ability to influence and drive alignment across diverse internal and external collaborators.
Strong strategic thinking and problem solving skills, with demonstrated success in navigating complex regulatory environments.
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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr
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
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 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
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 impact on oncology diagnostic testing.
Aid in selection of diagnostic assay methodologies. Maintain familiarity with relevant regulatory requirements both within the US and abroad.
Qualifications
Master’s Degree in a relevant scientific discipline (e.g., molecular biology, biochemistry or related field) is required; PhD Degree strongly preferred
Minimum of 7-10 years of industry experience in companion diagnostics (CDx) development and in vitro assay development is required.
10+ years of experience in diagnostic strategy and/or clinical biomarker development, including track record of successful regulatory submissions, is strongly preferred.
Demonstrated expertise in Oncology diagnostics with Hematologic malignancy experience is strongly preferred
Deep understanding of regulatory and clinical requirements for diagnostics development and commercialization, including global regulatory frameworks (e.g., FDA, EMEA, PMDA).
Proven ability to lead cross functional teams and manage external diagnostics partnerships across global programs.
Excellent communication and stakeholder engagement skills, with ability to influence and drive alignment across diverse internal and external collaborators.
Strong strategic thinking and problem solving skills, with demonstrated success in navigating complex regulatory environments.
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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr