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:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Cambridge, Massachusetts, United States of America, La Jolla, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Neuroscience

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 Neuroscience team tackles the world’s toughest brain health challenges including: Alzheimer’s disease, Parkinson’s disease, myasthenia gravis, major depressive disorder, bipolar disorder, schizophrenia, and geographic atrophy. This patient-focused team helps address some of the most complex diseases of our time.

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 Director Diagnostics Development Lead, Neuroscience to be in Titusville, NJ ; SpringHouse, PA, La Jolla, California, Cambridge, MA

Purpose: As Director - Diagnostics Development Lead, Neuroscience, you will be part of a newly formed team supporting compound development teams in the development, design of clinical trials, and market implementation strategy for diagnostic tests in support of Neuroscience assets, in alignment with Precision Measures Plan and in collaboration with key stakeholders

• Collaborate with key stakeholders, including, but not limited to, Discovery, Precision Measures, Clinical Development, Disease Area Stronghold Leaders, Business Development, Regulatory and Commercial teams to develop a diagnostic strategy to enable registration of a pharmaceutical asset and subsequent access and adoption.

• Interact early with Discovery and Precision Measures groups to understand the predictive hypotheses to be tested for specific programs. Collaborate with internal teams to develop a predictive assay if required and not already available.
• Select contract laboratory for testing predictive assays in early clinical development.
• Oversee assay transfer to contract laboratory and ensure proper assay validation by working with subject matter experts within the department.
• Understand CLIA-laboratory, FDA testing guidelines and assay validation requirements; keep current with In Vitro Diagnostics (IVD) regulations globally
• Collaborate with Precision Measures and with Clinical Research to design studies to test the clinical utility of the diagnostic. Maintain alignment with clinical teams implementing relevant biomarker testing into clinical trials.
• Select diagnostic partner to deliver potential diagnostic kits in time for pharmaceutical registration.
• Manage strategic relationships with contract laboratories and diagnostic partners including ensuring in-stream data quality from partners and oversee timelines for IVD diagnostics approvals globally and align plans for commercialization
• Coordinate all activities between development teams and external diagnostic partners, ensuring alignment of diagnostic development milestones with clinical milestones and plans for commercialization by developing/tracking timelines, budgets, and resources towards ensuring delivery of critical milestones from diagnostic partner.
• Regularly communicates updates to, and seeks feedback from, Clinical Teams, Compound Development Teams, Disease Area Leadership, and other stakeholders where appropriate, surrounding progress of the diagnostic program.
• Work in a highly matrixed team environment to deliver diagnostic programs to enable registration of pharmaceuticals.
• Keep current with novel technologies that have impact on neuroscience diagnostic testing.
• Aid in selection of diagnostic assay methodologies.
• Maintain familiarity with relevant regulatory requirements globally.

Qualifications / Requirements:

• Master’s Degree is required, PhD Degree in Life Sciences is strongly preferred.
• At least 8-10 years of industry related experience in assay and In Vitro Diagnostics development, with excellent knowledge and understanding of design control process, analytical and clinical validation, manufacturing, GCP, GLP, and GMP requirements, Global IVD regulations and regulatory submissions, and commercialization of an IVD is strong preferred.
• Having experience leading a diagnostic development project is preferred.
• Drug Development experience is strongly preferred with knowledge and understanding of clinical trial design, efficacy endpoints, and biomarker testing.
• Proven experience working in teams and demonstrated experience with matrix leadership skills is required.
• Exceptional interpersonal and communication skills, with the ability to build strong relationships and influence without reporting authority.
• Exceptional analytical and critical thinking skills, with the ability to translate complex data (financial/operational) into actionable insights for strategic decision making.
• Exceptional communication and presentation skills,
• Travel up to 20% of time both domestic and international is required.

The anticipated base pay range for this position is:

$160, 000 - $276, 000

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be 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. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http: //www.careers.jnj.com/employee-benefits The 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.