Johnson Johnson is recruiting for a Distinguished Scientist, Clinical Pathology Safety Biomarkers located in Spring House, PA or La Jolla, CA.
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 Distinguished Scientist, Clinical Pathology Safety Biomarkers (CPSB), Pathobiology, Preclinical Sciences and Translational Safety (PSTS), is 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.
Key Responsibilities:
· 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 in 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 RD 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.
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. Reviews new/revised Standard Operating Procedures (SOPs) pertaining to clinical pathology. Supports compliance and safety guidelines, including implementation and adherence.
Johnson Johnson is recruiting for a Distinguished Scientist, Clinical Pathology Safety Biomarkers located in Spring House, PA or La Jolla, CA.
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 Distinguished Scientist, Clinical Pathology Safety Biomarkers (CPSB), Pathobiology, Preclinical Sciences and Translational Safety (PSTS), is 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.
Key Responsibilities:
· 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 in 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 RD 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.
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. Reviews new/revised Standard Operating Procedures (SOPs) pertaining to clinical pathology. Supports compliance and safety guidelines, including implementation and adherence.
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 desirable.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:
Excellent verbal and written communications skills required.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 requiredStrong scientific track record with publications in high quality journals requiredThe position requires demonstrated competence in all aspects of clinical pathology (Hematology, Coagulation, Clinical Chemistry, Urinalysis) with ability to maintain knowledge of toxicologic pathology and best practices requiredAbility to perform complex data analysis, integrating clinical signs and anatomic pathology findings to interpret clinical pathology data requiredPreferred:
Experience in developing nonclinical safety strategies in a drug development setting strongly preferred.Experience with data driven hypothesis-testing approaches aimed at resolving pre-clinical or clinical issues of safety concern strongly preferred.Experience in novel modalities (including but not limited to cell and gene therapies, CART, ADC) required strongly preferred. Experience with translational safety biomarker development/qualification strongly preferred.Experience with Good Laboratory Practices strongly preferred.The anticipated base pay range for this position is $187,000 - $322,000 USD
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to:
https://www.careers.jnj.com/employee-benefits
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 visitwww.careers.jnj.com
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 desirable.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:
Excellent verbal and written communications skills required.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 requiredStrong scientific track record with publications in high quality journals requiredThe position requires demonstrated competence in all aspects of clinical pathology (Hematology, Coagulation, Clinical Chemistry, Urinalysis) with ability to maintain knowledge of toxicologic pathology and best practices requiredAbility to perform complex data analysis, integrating clinical signs and anatomic pathology findings to interpret clinical pathology data requiredPreferred:
Experience in developing nonclinical safety strategies in a drug development setting strongly preferred.Experience with data driven hypothesis-testing approaches aimed at resolving pre-clinical or clinical issues of safety concern strongly preferred.Experience in novel modalities (including but not limited to cell and gene therapies, CART, ADC) required strongly preferred. Experience with translational safety biomarker development/qualification strongly preferred.Experience with Good Laboratory Practices strongly preferred.The anticipated base pay range for this position is $187,000 - $322,000 USD
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to:
https://www.careers.jnj.com/employee-benefits
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 visitwww.careers.jnj.com