Johnson & Johnson is recruiting for a Senior Principal Scientist, Clinical Pathology & Safety Biomarkers located in Spring House, PA.
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.com/.
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The Senior Principal Scientist, CPSB is a global role that provides 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 ensures 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 collaborates with laboratory personnel to support analytical method optimization and advance the development, use and application of innovative platforms and technologies aimed at improving Translational Safety Biomarkers.
The Senior Principal Scientist, CPSB serves on project teams to develop nonclinical safety strategies and participates on issue management teams to investigate mechanistic aspects or develop monitorability for safety findings. Develops 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 serves 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.
Role models, champions and creates an environment that encourages the company's commitment to equal employment opportunity and the value of a diverse work force.
The Senior Principal Scientist, CPSB reports to the Global Head of CPSB as a member of the CPSB 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.
Qualifications
Education:
- DVM/VMD (Doctor of Veterinary Medicine) degree or equivalent required
- PhD, MS or other advanced graduate degree in pathology or a related field strongly 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.
Experience and Skills
Required:
- For candidates without a PhD, minimum of 3 years post-DVM/residency experience in clinical pathology data interpretation in academic toxicologic pathology and/or industry setting required. For candidates with a PhD, a PhD in the field of toxicology may substitute for industry experience.
- 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 is required
- Competence in all aspects of clinical pathology (Hematology, Clinical Chemistry, Urinalysis) with ability to maintain knowledge of toxicologic pathology and best practices is required
- 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 is required
- Ability to perform complex data analysis, integrating clinical signs and anatomic pathology findings to interpret clinical pathology data is required
- Willingness to work across time zones and some travel may be required
Preferred:
- Additional board certifications in Toxicology is preferred
- Experience in developing nonclinical safety strategies and clinical pathology data interpretation in toxicological pathology and/or industry setting is preferred
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.
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