Johnson & Johnson Innovative Medicine
Senior Principal Scientist, Nonclinical Safety Lead
Johnson & Johnson Innovative Medicine, Spring House, Pennsylvania, United States, 19477
Senior Principal Scientist, Nonclinical Safety Lead
Johnson & Johnson Innovative Medicine is hiring a Senior Principal Scientist, Nonclinical Safety Lead. This is a hybrid role located in Spring House, PA.
Overview As the Nonclinical Safety (NCS) Lead, you will collaborate with innovative scientists to support projects across a large and varied portfolio that spans multiple therapeutic areas and modalities. You will provide toxicology leadership for all aspects of discovery and development, with flexibility to specialize or work across stages of development, therapy areas, and modalities. You will also collaborate with discovery scientists to identify and nominate candidate molecules, and with development teams to advance these molecules toward humans and through global registration.
Responsibilities
Lead PSTS project teams of nonclinical safety and Pharmacokinetic (PK) scientists, ensuring efficient information transfer within the team.
Serve as the NCS representative for global project teams, providing toxicology expertise and interfacing with senior management.
Create target risk assessments and develop plans to screen for and mitigate potential risks; analyze toxicology and safety pharmacology studies, contextualizing results for human safety and preparing nonclinical safety assessments.
Contribute to issue-resolution teams by generating hypotheses and investigative strategies.
Accountable for global regulatory nonclinical documents and health authority responses to support clinical trials and compound registrations.
Participate in medical safety teams, signal detection analyses, and risk mitigation strategies.
Engage in nonclinical safety risk assessments for due diligence of potential licensing & acquisition opportunities, as needed.
Collaborate with Chemistry, Manufacturing and Controls (CMC) to assure drug substance quality.
Participate in external academic or industry societies and consortia to enhance toxicology strategies and capabilities, as needed.
Maintain scientific depth and knowledge in competitive intelligence and regulatory landscapes for assigned projects.
Communicate effectively with stakeholders, including regulatory authorities, leveraging drug development experience.
Qualifications
A minimum of a Master’s degree in Toxicology, Pharmacology or related discipline is required. Doctoral level degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology or related discipline is preferred.
A minimum of 12 years of pharmaceutical/biotech industry experience in preclinical safety assessment supporting discovery/development with a Master’s degree, or a minimum of 8 years with a doctoral level degree (PhD, DVM, MD or equivalent).
Experience representing toxicology/nonclinical safety on multi-disciplinary project teams.
Strong understanding of the drug discovery/development process is required.
Experience in conducting due diligence activities is preferred.
Previous experience as a Study Director/Study Monitor under GLP regulations is preferred.
Familiarity with various therapeutic modalities is preferred.
Board certification (e.g. Diplomate of the American Board of Toxicology, DABT) is preferred.
Excellent oral and written communication skills.
Ability to critically evaluate, interpret and integrate large datasets and literature is required.
Equal Opportunity Employer Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers; internal employees contact AskGS for accommodation assistance.
Location Spring House, Pennsylvania, United States
#J-18808-Ljbffr
Overview As the Nonclinical Safety (NCS) Lead, you will collaborate with innovative scientists to support projects across a large and varied portfolio that spans multiple therapeutic areas and modalities. You will provide toxicology leadership for all aspects of discovery and development, with flexibility to specialize or work across stages of development, therapy areas, and modalities. You will also collaborate with discovery scientists to identify and nominate candidate molecules, and with development teams to advance these molecules toward humans and through global registration.
Responsibilities
Lead PSTS project teams of nonclinical safety and Pharmacokinetic (PK) scientists, ensuring efficient information transfer within the team.
Serve as the NCS representative for global project teams, providing toxicology expertise and interfacing with senior management.
Create target risk assessments and develop plans to screen for and mitigate potential risks; analyze toxicology and safety pharmacology studies, contextualizing results for human safety and preparing nonclinical safety assessments.
Contribute to issue-resolution teams by generating hypotheses and investigative strategies.
Accountable for global regulatory nonclinical documents and health authority responses to support clinical trials and compound registrations.
Participate in medical safety teams, signal detection analyses, and risk mitigation strategies.
Engage in nonclinical safety risk assessments for due diligence of potential licensing & acquisition opportunities, as needed.
Collaborate with Chemistry, Manufacturing and Controls (CMC) to assure drug substance quality.
Participate in external academic or industry societies and consortia to enhance toxicology strategies and capabilities, as needed.
Maintain scientific depth and knowledge in competitive intelligence and regulatory landscapes for assigned projects.
Communicate effectively with stakeholders, including regulatory authorities, leveraging drug development experience.
Qualifications
A minimum of a Master’s degree in Toxicology, Pharmacology or related discipline is required. Doctoral level degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology or related discipline is preferred.
A minimum of 12 years of pharmaceutical/biotech industry experience in preclinical safety assessment supporting discovery/development with a Master’s degree, or a minimum of 8 years with a doctoral level degree (PhD, DVM, MD or equivalent).
Experience representing toxicology/nonclinical safety on multi-disciplinary project teams.
Strong understanding of the drug discovery/development process is required.
Experience in conducting due diligence activities is preferred.
Previous experience as a Study Director/Study Monitor under GLP regulations is preferred.
Familiarity with various therapeutic modalities is preferred.
Board certification (e.g. Diplomate of the American Board of Toxicology, DABT) is preferred.
Excellent oral and written communication skills.
Ability to critically evaluate, interpret and integrate large datasets and literature is required.
Equal Opportunity Employer Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers; internal employees contact AskGS for accommodation assistance.
Location Spring House, Pennsylvania, United States
#J-18808-Ljbffr