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Johnson & Johnson is recruiting for a Distinguished Global Translational Biomarker Lead lo cated 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/.

For 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.

We 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.

At Johnson & Johnson, we all belong.

The Global Translational Biomarker Lead, Clinical Pathology & Safety Biomarkers (CPSB), Pathobiology, Preclinical Sciences and Translational Safety (PSTS), is a well-recognized, highly published distinguished expert in Clinical Pathology & Translational Safety Biomarker development. Establishes a new center for translational biomarker innovation, leading a team of medical laboratory and biomarker scientists to develop the PSTS translational safety biomarker infrastructure and execute end-to-end (efficacy-to-safety, Discovery through Post-Marketing) translational biomarker strategies across all J&J modalities and therapeutic areas. Leads the generation of high quality, leading-edge, decision-driving biomarker data and bioanalytical methods/analyses ranging from routine clinical pathology (e.g. hematology, coagulation, clinical chemistry, urinalysis) to specialized medical diagnostics and biomarkers (e.g. blood gas analysis, platelet function and aggregometry, molecular diagnostics, clinical mass spectrometry, immunoassays, flow cytometry and translational bioinformatics). Partners with Global Safety to establish new Translational Safety Biomarker collaborative model. Requires D.V.M. qualifications, as well as current ACVP board certification in clinical pathology. The Global Translational Biomarker Lead, Clinical Pathology & Safety Biomarkers (CPSB) will report to the Global Head of CPSB as a member of the CPSB Leadership Team.

Key Responsibilities:

• Establishes and leads a central laboratory focused on translational biomarker development and innovation. Accountable for team’s execution of analytical strategies including routine clinical pathology and non-routine biomarkers, with little to no supervision. Coordinates deliverables with diverse stakeholders across Pathobiology and PSTS. Accountable for design, development, implementation and execution of fit-for-purpose assays and validation reports, and generation of high-quality clinical pathology and biomarker data and interpretive reports. Oversees all laboratory operations, setting and driving priorities, ensuring scientific rigor, timely delivery, managing employee performance and development and implementing workforce and succession plans to meet business needs. Oversees maintenance Standard Operating Procedures (SOPs) pertaining to Laboratory operations. Ensures compliance and safety guidelines, including implementation and adherence. 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.

• Develops comprehensive fit-for-purpose and innovative translational safety biomarker strategies for early target/modality/molecule putative liability assessment and risk mitigation. Collaborates closely with Target Clinical Pathologists and Immunotoxicologists to align on biomarker selection and assay methodology. 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. 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 in or leads issue management/resolution teams.

• 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. Serves as a delegate of the Global Head of CPSB in governance and leadership teams. Builds partnerships and relationships with internal R&D leaders and the external scientific community to advance Translational Safety Biomarker science. Participates in internal/external scientific leadership in initiatives and consortia to be at the forefront of emerging biomarker technologies and partners with Global Medical Safety and translational safety to advance implementation safety biomarkers. Proactively 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.

Key Competencies:

• Strong scientific track record with publications in high quality journals and presentations at conferences.

• Demonstrated competence in all aspects of clinical pathology (Hematology, Coagulation, Clinical Chemistry, Urinalysis) with ability to maintain knowledge of toxicologic pathology and best practices. Ability to perform complex data analysis, integrating clinical signs and anatomic pathology findings to interpret clinical pathology data.

• Recognized subject matter expertise in specialized medical diagnostics and biomarkers (e.g. blood gas analysis, platelet function and aggregometry, molecular diagnostics, clinical mass spectrometry, immunoassays, flow cytometry and translational bioinformatics).

• Hands on knowledge of various Laboratory Information Management Systems such as Thermo Watson, LabVantage, ELN, Pristima etc. as well as database management.

• Excellent interpersonal skills required. Demonstrated ability to work effectively within a diverse team of pathologists and multidisciplinary scientists, including effective collaboration and communication to senior leaders and stakeholders, with a strong focus on effective communication, quality and results-oriented collaboration, personal commitment to continual learning and career development ownership.

• Ability to work across time zones and some travel (<25%).

Qualifications

Education:

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

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

• Additional certifications (e.g. DABT or Anatomic Pathology) are highly preferred.

• PhD in Pathology, Toxicology or a related field with a minimum of 10 years post-DVM/PhD residency experience interpreting laboratory animal clinical pathology data in a drug development setting required. OR Post-DVM training in Pathology, Toxicology or a related field with a minimum of 15 years of research experience designing and executing hypothesis-driven experiments and experience interpreting laboratory animal clinical pathology data in a drug development setting is required.

Experience and Skills:

Required:

• Experience with one or more specific biomarker technologies (e.g. flow cytometry, molecular assays) is required.

• Experience managing people is required.

Preferred:

• Experience with Good Laboratory Practices preferred.

• Experience with translational (nonclinical & clinical) safety biomarker development strongly preferred.

• Experience with data driven hypothesis-testing approaches aimed at resolving pre-clinical or clinical issues of safety concern by leveraging biomarkers strongly preferred.

• Experience with novel modalities (including but not limited to cell and gene therapies, CART, ADC) 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