Associate Director, Clinical Pathology & Safety Biomarkers

Auris Health

Auris Health

United States
Posted on Tuesday, August 15, 2023
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Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, Clinical Pathology & Safety Biomarkers located in Spring House, PA or remote for the ideal candidate.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.   Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Associate Director, Clinical Pathology & Safety Biomarkers (CPSB) is a global role that will providing comprehensive evaluations of clinical pathology and biomarker data and interpretive reports to support target and candidate confidence in rationale/mechanism and confidence in safety. In collaboration with study toxicologists, target pathologists and program leads, the candidate will ensure timely delivery, interpretation and correlation of study findings in support of early discovery, lead optimization, investigative studies and out-sourced GLP registrational toxicology studies. The role will collaborate with internal clinical pathology laboratory personnel globally in the US and Belgium to support clinical pathology analytical method optimization and advance the development, use and application of innovative platforms and technologies aimed at improving translational Safety Biomarkers.

The Associate Director CPSB will serve on project teams to develop nonclinical safety strategies and participate on issue management teams to investigate mechanistic aspects or develop monitorability for safety findings. Will have an active role in the Global Safety Biomarker Steering Committee and will develop collaborative cross functional partnerships with early discovery teams and nonclinical safety teams to advise on the strategic implementation of routine and nonroutine safety biomarkers. The role will serve as subject matter expert (SME) in reviewing regulatory dossiers and responding to health authority queries, working closely with regulatory and portfolio groups. Leadership in external influence such as within precompetitive consortia is within the scope of this role.

Will role model, champion and create an environment that encourages the company’s commitment to equal employment opportunity and the value of a diverse work force.

The Associate Director, Clinical Pathology & Safety Biomarkers (PSTS) will report to the Global Head of Clinical Pathology Safety Biomarkers PSTS as a member of the Clinical Pathology Safety Biomarkers Leadership Team.

Key Responsibilities:

·        Responsible for the comprehensive evaluation of clinical pathology data and reports from in vivo nonclinical studies, including ensuring relevant and appropriate correlations with other study endpoints.

·        Collaborates with study team members to ensure cohesive interpretation and communication of findings inclusive to study reports, internal communications, regulatory submissions and active participation in responses to regulatory agencies as necessary.

·        Provides scientific expertise for experimental design and conduct of research studies; including biomarker recommendations, protocol review, data review and interpretation, study report review.

·        Ensures delivery on timelines and performance consistent with quality and compliance to meet all business needs.

·        Provides scientific guidance to clinical pathology laboratory personnel, aids Study Directors in the interpretation of clinical pathology endpoints and assists in colleague training related to clinical pathology.

·        Evaluates study specimens related to clinical pathology, such as blood smears, bone marrow smears, urinalysis sediment preparations and body fluid preparations as appropriate.

·        Provides diagnostic support to Veterinary Services.

·        Assists in expanding the array of clinical pathology assays to meet contemporary needs and expectations. Participates in method development, and identification and evaluation of new instrumentation, as required. Keeps up to date with new clinical pathology and biomarker methodologies and technologies.

·        Represents CPSB within PSTS project teams, issues resolution teams and governance meetings.

·        Based on expertise, provides input at team meetings regarding inclusion of nonclinical biomarkers in discovery, general toxicology and/or mechanistic/investigative toxicology studies. Expands scientific expertise regarding nonclinical safety biomarkers by self-study, training and follow up of scientific literature in related domains. Supports the strategic vision for various internal and external collaborations to provide biomarkers that help deliver the most impactful compounds for various therapeutic indications.

·        Supports external influence by providing representation to external academic, consortium and industry biomarker efforts, which is important to continue to develop, validate, and implement new biomarkers and promote more effective drug development.

·        Reviews new/revised Standard Operating Procedures (SOPs) pertaining to clinical pathology.

·        Supports compliance and safety guidelines, including implementation and adherence.



·        DVM/VMD (Doctor of Veterinary Medicine) degree or equivalent required.

·        PhD, MS or other advanced graduate degree in pathology or a related field preferred.

·        American College of Veterinary Pathologists (ACVP) board certification with specialty in Clinical Pathology (or equivalent) required. Experience may not be substituted for board-certification at this level.



·        Minimum of 3-5 years post-DVM/PhD residency experience in clinical pathology data interpretation in toxicologic pathology and/or industry setting.

·        Strong verbal and written communications skills are required.

·        Strong interpersonal skills required. Demonstrated ability to work effectively within a large team of pathologists and scientists, with a strong focus on quality collaboration, continual learning and career development.

·        The position requires demonstrated competence in all aspects of clinical pathology (Hematology, Clinical Chemistry, Urinalysis) with ability to maintain knowledge of toxicologic pathology and best practices.

·        Experience with data driven hypothesis-testing approaches aimed at resolving pre-clinical or clinical issues of safety concern that could impede progression of drug candidates.

·        Ability to perform complex data analysis, integrating clinical signs and anatomic pathology findings to interpret clinical pathology data.

Other :

·        Global team, will require willingness to work across time zones and some travel.

·        Additional board certifications in Toxicology

·        Experience in developing nonclinical safety strategies and clinical pathology data interpretation in toxicological pathology and/or industry setting.

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 .

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

Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits