Distinguished Scientist, Clinical Pathology & Safety Biomarkers - San Diego California

Company: Disability Solutions
Location: San Diego, California
Posted On: 02/03/2025

Johnson & Johnson is recruiting for a Distinguished Scientist, Clinical Pathology& Safety Biomarkers located in Spring House, PA or La Jolla, CA.\rAt 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/.\rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.\rWe know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.\rAt Johnson & Johnson, we all belong.\rThe Distinguished Scientist, Clinical Pathology& Safety Biomarkers(CPSB), Pathobiology, Preclinical Sciences and Translational Safety (PSTS), i s an internally and externally recognized, highly published distinguished expert in Clinical Pathology & Safety Biomarkers. An individual contributor that operates independently as Target Clinical Pathologist on global PSTS teams, leads complex nonclinical safety biomarker strategies in support of drug development projects and mentors junior clinical pathologists in a matrix. Requires D.V.M. qualifications, as well as current ACVP board certification in clinical pathology. The Distinguished Scientist will report to the Global Head of CPSB as a member of the CPSB Leadership Team.\r\rKey Responsibilities:

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• Independently develops comprehensive fit-for-purpose and innovative nonclinical safety biomarker strategies for projects across modalities and therapeutic areas and through the entire drug development process, including early target/modality/molecule putative liability assessment and risk mitigation.
• Guides the implementation of routine and specialized CPSB endpoints in nonclinical studies to ensure generation of timely and high-quality data to inform robust safety assessments.
• Independently delivers high quality, timely and comprehensive evaluations of clinical pathology and biomarker data and interpretive reports/report reviews.
• Effectively communicates clear, concise, accurate and coherent integrated study conclusions and program recommendations to stakeholders internal to and external to PSTS, with limited supervisor input prior to release.
• Serves as subject matter expert(SME) in responses to health authority queries; reviews regulatory submission documents, working closely with regulatory and portfolio groups to inform regulatory strategy; provides rigorous assessments for diligence decisions. Participates i n or leads issue management/resolution teams.
• Provides SME consultation and guidance to PSTS teams, PSTS leadership and external stakeholders to support target and candidate molecule confidence in rationale/mechanism of efficacy and safety, with stage appropriate human risk assessments to help guide and shape short and midterm department and pipeline strategies.
• Executes the strategic translational safety biomarker vision and leads CPSB strategic initiatives aimed at developing and implementing novel biomarkers. Drives the development, evaluation, implementation and application of innovative platforms and assays aimed at improving translational Safety Biomarker support and process efficiency and quality. Guides CPSB and Immunotoxicology scientific and technical staff to implement impactful biomarker assays.
• Builds partnerships and relationships with internal R&D leaders and the external scientific community to advance Translational Safety Biomarker science. Drives external reputation and influence via external scientific conferences, professional associations, and consortia. Leadership such as within external precompetitive consortia and participation in safety advisory groups are within the scope of this role.
• Acts as a functional leader, guides other colleagues through consultation, mentoring, and collaborative leadership to build depth of capability within CPSB and PSTS, and provides functional (matrix) supervision as required. May serve as a delegate of the Global Head of CPSB in governance and leadership teams.\rProactively creates a purpose driven environment by aligning Johnson & Johnson's Credo and Leadership Imperatives (Connect, Shape and Grow) with the strategies and goals of the team and enterprise. Reviews new/revised Standard Operating Procedures(SOPs) pertaining to clinical pathology. Supports compliance and safety guidelines, including implementation and adherence.\r More...

      

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