Karkidi
Director, Neuropsychologist
Karkidi, New Brunswick, New Jersey, us, 08933
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https://www.jnj.com/Accurate, and reliable assessment of neuropsychological function is critical in the research and development of new indications for the treatment and prevention of neuropsychiatric and neurodegenerative disorders. The Clinical Scientist (neuropsychologist) is a neuropsychologist with expertise and knowledge of the neuropsychological assessments used in clinical trials, in particular related to neurodegenerative disorders like Alzheimer's Disease and neuropsychiatric disorders such as major depressive disorder and psychotic disorders. They are responsible for developing and supporting the implementation of a neuropsychological assessment strategy across several neuropsychiatric and neurodegenerative compounds. They actively contribute to the compound development portfolio and strategy from scientific and commercial perspectives, with a goal of progressing and deploying optimal measurement strategies for cognitive and other neuropsychological outcomes. This role requires an innovative approach, alongside highly effective leadership, cross-functional collaboration, and the ability to build and cultivate external collaborations with leading academic researchers, to ensure seamless execution of the cognitive strategy supporting neuropsychiatric and neurodegeneration compounds.Key Responsibilities:
Leads the development and maintenance of the neuropsychological/cognitive outcome strategy for neuropsychiatric and neurodegeneration compounds, including interactions with the TA Leadership Team to develop a compound-specific strategy.Evaluates the disease state and mechanism of action of a compound to determine appropriate testing for clinical protocols based on short and long-term potential effects, population, and outcome variables.Maximizes innovation from research and collaborates effectively with internal and external partners to ensure strategy is considered leading in the field.Works closely with cross-functional partners, for example, Discovery/Biomarkers, Clinical Development, and Data Science to guide the design, implementation, analysis, and interpretation of the neuropsychological assessments in compound development programs.Aids in the development of study documents (including protocol, SAP, and CSR) relating to neuropsychology/cognition and writes or leads review of reports and interpretation of cognition data from external partners.Participates in monitoring and reporting of cognition-related safety data in partnership with the study team, including evaluation of cognition-related clinical trial adverse events.Leads vetting and quality assessment process for vendors providing neuropsychological assessments for use in clinical trials.Oversees rater selection, training, and in-study rater reliability evaluation for neuropsychological assessments. Guides related process improvements.Identifies critical risks and leads issue resolution relating to compound-specific cognitive/clinical strategy; plans and communicates risks/issues/plans to the development team, critical functions, governance committees, and senior management.Participates in external initiatives regarding neuropsychological assessments including but not limited to the development of new cognitive/functional composites and analyses to identify the most sensitive digital tools for use in remote assessment.Maintains subject matter expertise in the domain, including Health Authority regulations/ documents, and actively shares knowledge across teams to increase the overall level of awareness/knowledge in clinical development.May perform other duties as assigned!Principal Relationships:
Will be a member of the Scientific Strategy and Clinical Execution group working closely with Clinical Scientist team and other members of the Clinical Team – Compound Development Team Leader, Clinical Lead, Study Responsible Physician. Contacts outside of the group include leaders of functional areas and teams such as Data Science, Market Access, Legal and Global Medical Affairs.Develops and maintains relationships with scientific leaders and may act as a company spokesperson regarding the publication of clinical cognitive research findings, including presentations to relevant health authorities.QUALIFICATIONS
Education:
Doctoral level Degree (PhD) in clinical neuropsychology or equivalent to allow practice as a clinical neuropsychologist is requiredExperience and Skills:
Required:
Minimum of 8 years professional experience is requiredClinical and research experience in neurodegeneration, specifically, AD is required.An extensive background and advanced training in neuropsychological assessment including remote and clinician-administered computerized test batteries, and clinical trial design and methodology is requiredExperience in the translation of biomarkers into clinically meaningful outcomes is requiredA strong scientific and research background with strong analytical skills with the ability to go beyond evaluation, to execution and delivery of chosen projects and alliances is requiredLeadership experience and proven track record in influencing and integrating input from cross-functional teams into a successful strategy and project plan is requiredExperience of the drug development process and the competitive environment is requiredFluent in written and spoken English with excellent interpersonal and presentation skills is requiredLearning agility, flexibility, and skills for developing creative solutions to deliver across tasks and projects is requiredSolid understanding of the use of Microsoft suite of software products including Excel, PowerPoint, and Word is requiredExperience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and contributions to regulatory filings is requiredThis position may require approximately 25% global travelPreferred:
Experience in neuropsychiatry areas, such as Mood and Psychoses, is preferredJohnson & 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.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
www.careers.jnj.com
#J-18808-Ljbffr
https://www.jnj.com/Accurate, and reliable assessment of neuropsychological function is critical in the research and development of new indications for the treatment and prevention of neuropsychiatric and neurodegenerative disorders. The Clinical Scientist (neuropsychologist) is a neuropsychologist with expertise and knowledge of the neuropsychological assessments used in clinical trials, in particular related to neurodegenerative disorders like Alzheimer's Disease and neuropsychiatric disorders such as major depressive disorder and psychotic disorders. They are responsible for developing and supporting the implementation of a neuropsychological assessment strategy across several neuropsychiatric and neurodegenerative compounds. They actively contribute to the compound development portfolio and strategy from scientific and commercial perspectives, with a goal of progressing and deploying optimal measurement strategies for cognitive and other neuropsychological outcomes. This role requires an innovative approach, alongside highly effective leadership, cross-functional collaboration, and the ability to build and cultivate external collaborations with leading academic researchers, to ensure seamless execution of the cognitive strategy supporting neuropsychiatric and neurodegeneration compounds.Key Responsibilities:
Leads the development and maintenance of the neuropsychological/cognitive outcome strategy for neuropsychiatric and neurodegeneration compounds, including interactions with the TA Leadership Team to develop a compound-specific strategy.Evaluates the disease state and mechanism of action of a compound to determine appropriate testing for clinical protocols based on short and long-term potential effects, population, and outcome variables.Maximizes innovation from research and collaborates effectively with internal and external partners to ensure strategy is considered leading in the field.Works closely with cross-functional partners, for example, Discovery/Biomarkers, Clinical Development, and Data Science to guide the design, implementation, analysis, and interpretation of the neuropsychological assessments in compound development programs.Aids in the development of study documents (including protocol, SAP, and CSR) relating to neuropsychology/cognition and writes or leads review of reports and interpretation of cognition data from external partners.Participates in monitoring and reporting of cognition-related safety data in partnership with the study team, including evaluation of cognition-related clinical trial adverse events.Leads vetting and quality assessment process for vendors providing neuropsychological assessments for use in clinical trials.Oversees rater selection, training, and in-study rater reliability evaluation for neuropsychological assessments. Guides related process improvements.Identifies critical risks and leads issue resolution relating to compound-specific cognitive/clinical strategy; plans and communicates risks/issues/plans to the development team, critical functions, governance committees, and senior management.Participates in external initiatives regarding neuropsychological assessments including but not limited to the development of new cognitive/functional composites and analyses to identify the most sensitive digital tools for use in remote assessment.Maintains subject matter expertise in the domain, including Health Authority regulations/ documents, and actively shares knowledge across teams to increase the overall level of awareness/knowledge in clinical development.May perform other duties as assigned!Principal Relationships:
Will be a member of the Scientific Strategy and Clinical Execution group working closely with Clinical Scientist team and other members of the Clinical Team – Compound Development Team Leader, Clinical Lead, Study Responsible Physician. Contacts outside of the group include leaders of functional areas and teams such as Data Science, Market Access, Legal and Global Medical Affairs.Develops and maintains relationships with scientific leaders and may act as a company spokesperson regarding the publication of clinical cognitive research findings, including presentations to relevant health authorities.QUALIFICATIONS
Education:
Doctoral level Degree (PhD) in clinical neuropsychology or equivalent to allow practice as a clinical neuropsychologist is requiredExperience and Skills:
Required:
Minimum of 8 years professional experience is requiredClinical and research experience in neurodegeneration, specifically, AD is required.An extensive background and advanced training in neuropsychological assessment including remote and clinician-administered computerized test batteries, and clinical trial design and methodology is requiredExperience in the translation of biomarkers into clinically meaningful outcomes is requiredA strong scientific and research background with strong analytical skills with the ability to go beyond evaluation, to execution and delivery of chosen projects and alliances is requiredLeadership experience and proven track record in influencing and integrating input from cross-functional teams into a successful strategy and project plan is requiredExperience of the drug development process and the competitive environment is requiredFluent in written and spoken English with excellent interpersonal and presentation skills is requiredLearning agility, flexibility, and skills for developing creative solutions to deliver across tasks and projects is requiredSolid understanding of the use of Microsoft suite of software products including Excel, PowerPoint, and Word is requiredExperience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and contributions to regulatory filings is requiredThis position may require approximately 25% global travelPreferred:
Experience in neuropsychiatry areas, such as Mood and Psychoses, is preferredJohnson & 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.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
www.careers.jnj.com
#J-18808-Ljbffr