Director, Clinical Science Biomarker Integration Neuroscience
Company: Disability Solutions
Location: San Diego
Posted on: March 16, 2025
Job Description:
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.comJob Function: Discovery & Pre-Clinical/Clinical
DevelopmentJob Sub Function: Clinical Development & Research -
Non-MDJob Category:Scientific/TechnologyAll Job Posting
Locations:La Jolla, California, United States of America, Raritan,
New Jersey, United States of America, Spring House, Pennsylvania,
United States of America, Titusville, New Jersey, United States of
AmericaJob Description:We are searching for the best talent for
Director Clinical Sciences Biomarker Integration, Neuroscience to
be in La Jolla, California; Raritan or Titusville, NJ or
SpringHouse PA.Scientific Strategy and Clinical Execution is an
integrated group of clinical scientists within Neuroscience
Clinical Development to support the end-to-end portfolio. SSCE
provides the necessary scientific and clinical expertise to advance
an industry-leading pipeline of novel mechanism compounds to
address unmet need in disease in the neuroscience therapeutic area.
Purpose: The Director Clinical Sciences Biomarkers Integration
Neuroscience directs and implements the end-to-end Biomarker
Strategy in support of the Neuroscience Clinical Development
Programs, in alignment with Precision Measures Plan in
collaboration with key stakeholders.The Director Clinical Sciences
Biomarkers Integration Neuroscience is the leader of a team that
integrates novel biomarker and innovative and state-of-the art
sampling and analysis methodologies and processing procedures in
the NS Clinical Development Programs. The Director Clinical
Sciences has People Leader responsibilities for their team and
manages the NS portfolio of work within their team.They are
accountable for analysis, interpretation and reporting of fluid &
tissue biomarker data in NS clinical development programs and for
sample retention strategy creating optimal value to NS portfolio of
products. They are accountable for end-to-end tracking for all
human samples from these programs, including budgetary and
contractual oversight.They are accountable for selection and
scientific oversight of analysis vendors for fluid & tissue
biomarkers.They oversee the transition of knowledge on (validated)
Fluid & Tissue Biomarkers assays from the Precision Measures
organization into Clinical Development. They collaborate closely
with the Clinical Scientists and Clinical Operations teams
allocated to the programs to ensure timely analysis and reporting
within clinical programs and training of internal personnel related
to fluid & tissue biomarkers. They collaborate with the
pharmacodiagnostics team.The Director Clinical Sciences Biomarkers
Neuroscience reports into the Executive Director Clinical Sciences
Neuro, as part of Scientific Strategy and Clinical Execution.You
will be responsible for:
- Collaborate with key stakeholders, including, but not limited
to, Precision Measures, Clinical Development, Regulatory, Biobank
and Commercial teams to develop and implement a tissue and fluid
biomarker strategy as part of clinical development programs and
subsequent analysis, reporting and publication.
- As a member of the clinical team, implements the biomarker
strategy into core documents to ensure alignment with program
milestones (non-exhaustive list: protocol elements document,
protocol, informed consent form, statistical analysis plan, sample
mgt plans and data transfer agreements)
- Scientific oversight of vendor selection & management (fluid &
tissue biomarker testing, analysis & reporting)
- Oversee assay transfer to contract laboratory and ensure proper
assay validation by working with subject matter experts within the
therapeutic area.
- Scientific and technical input into lab contracting and Scope
of Work
- Interpretation and reporting of biomarker data in reg. reports
and scientific literature
- Develop and maintain relationships with the Precision Measures
organization, ensure appropriate knowledge sharing and training to
the clinical development group
- Develop training package related to fluid & tissue biomarkers
for training of clinical scientists and other internal personnel &
be available as consultant to teams related to transferred
responsibilities
- Develops and obtains senior management alignment on strategy to
optimize use of our samples and meet discovery, measurement
development and clinical development needs
- Provide clinical development input on procedures relevant to
biomarkers and supporting systems and ensure compliant
implementation
- Forecasting and budget oversight for long term storage
- Keep current on novel/new biomarkers and novel technologies
that have impact on biomarker testing in Neuroscience and on
regulatory requirement globally such as CLIA-laboratory, FDA
testing guidelines and manage assay validation requirements.
- Maintain current with scientific and academic community
- Actively pursue publication of biomarker data in alignment with
clinical program publication strategy
- Manage relationships with contract laboratories and academic
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, the Precision Measures
Advisory Group and other stakeholders where appropriate,
surrounding progress of the biomarkers execution and implementation
program.
- Supervise personnelQualifications / Requirements:
- PhD Degree is required with a minimum of 8 years industry
experience
- 10 years of drug discovery & development experience is
required
- Experience with biomarker development and clinical development
is required
- Neuroscience experience is required
- Breath of experience in leading people of varying levels via
coaching and open conversations to reach their full potential,
while also providing support and guidance during periods of poor
performance.
- Exceptional interpersonal and communication skills, with the
ability to build strong relationships and influence without
reporting authority.
- Proven experience and expertise in leading and managing in a
matrix organizational structure.
- 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, with the
ability to clearly articulate complex ideas to senior
management.
- Excellent knowledge of financial concepts.
- Travel up to 20% of time both domestic and international is
required.The anticipated base pay range for this position is
$160,000 to $276,000 USD.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.Employees may be eligible to participate in Company employee
benefit programs such as health insurance, savings plan, pension
plan, disability plan, long term incentives, vacation pay, sick
time, holiday pay, and work, personal and family time off in
accordance with the terms of the applicable plans. Additional
information can be found through the link below. For additional
general information on Company benefits, please go to: .Johnson &
Johnson is an Affirmative Action and 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, or protected veteran status
and will not be discriminated against on the basis of
disability.Johnson and Johnson is committed to providing interview
process that are 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.
Keywords: Disability Solutions, San Diego , Director, Clinical Science Biomarker Integration Neuroscience, Healthcare , San Diego, California
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