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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All 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 America

Job 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 personnel

Qualifications / 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: https://www.careers.jnj.com/employee-benefits .

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.