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

JOB DESCRIPTION:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Johnson & Johnson Innovative Medicine R&D is recruiting for a Principal Scientist Early Discovery, Non Clinical Safety Lead. This position is a hybrid role and will be located in San Diego, California.
As a Principal Scientist Early Discovery, Non Clinical Safety Lead, you will collaborate with innovative and diverse scientists to support projects in our large and varied portfolio that spans multiple therapeutic areas and includes innovative modalities. In this vital role you will provide toxicology leadership for all aspects of discovery and development projects, 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 bring these molecules to humans and ultimately through global registration.

Principal Responsibilities:

• Lead in the application and design of Ai/ML based platform technologies to assess biology and molecule-based risk working with colleagues in Therapeutic discovery, Data Science and IT.
• Analyze results of in silico, in vitro and in vivo toxicology as well as of safety pharmacology studies and literature data, apply strategic perspective to results, and compile nonclinical safety assessments with a focus on translation for patients
• Represent PSTS on global discovery project teams, serving as a critical point of contact to the project team for safety, toxicology expertise and guidance
• Lead the early team of nonclinical safety, PK , bioanalytical, pathobiology, and in vivo scientists (PSTS team) working on a project. Ensure the smooth transfer of necessary information to functional areas within PSTS in conjunction with the PSTS team.
• Collaborate with multi-disciplinary project teams to validate, prioritize and de-risk drug targets and early candidate molecules. Provide nonclinical findings, target expression and target risk input to the clinical protocols, informed consent forms, and monitoring protocols.
• Lead target risk assessments and develop fit-for-purpose plans to screen for and manage potential liabilities of novel targets and therapeutics.
• Develop nonclinical safety strategies for different modalities and/or routes of administration based on an integration of literature, regulatory guidance, and involvement with professional organizations to inform project advancement decisions.
• In issue-resolution teams, provide key contributions to hypotheses generation and leadership to drive rapid and impactful outcomes.
• Use your drug development experience to effectively communicate across all levels with internal and external partners, governance meetings, and meetings with global regulatory authorities. This requires excellent communication and negotiation skills.
• Participate in due diligence activities on potential L&A opportunities.

Qualifications:

• A minimum of a Master’s degree in Toxicology, Pharmacology or a related discipline is required. Doctoral level degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology or related discipline is preferred.
• A minimum of 6 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a Master’s degree or 3 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a doctoral level degree (PhD, DVM, MD or equivalent) is required.
• Broad understanding of the drug discovery/development process is required.
• Experience with different therapeutic modalities, such as small molecules, peptides, bi-specific antibodies, RNA-targeting therapeutics, cell-based therapy, and/or gene therapy, is preferred.
• Experience representing toxicology/nonclinical safety on matrix project teams is preferred.
• Board certification (e.g. Diplomate of the American Board of Toxicology (DABT)) is preferred.
• Must have excellent oral and written communication skills.
• The ability to critically evaluate, interpret and integrate large datasets and literature is required.

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 and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

LI-Hybrid

• Lead in the application and design of Ai/ML based platform technologies to assess biology and molecule-based risk working with colleagues in Therapeutic discovery, Data Science and IT.
• Analyze results of in silico, in vitro and in vivo toxicology as well as of safety pharmacology studies and literature data, apply strategic perspective to results, and compile nonclinical safety assessments with a focus on translation for patients
• Represent PSTS on global discovery project teams, serving as a critical point of contact to the project team for safety, toxicology expertise and guidance
• Lead the early team of nonclinical safety, PK , bioanalytical, pathobiology, and in vivo scientists (PSTS team) working on a project. Ensure the smooth transfer of necessary information to functional areas within PSTS in conjunction with the PSTS team.
• Collaborate with multi-disciplinary project teams to validate, prioritize and de-risk drug targets and early candidate molecules. Provide nonclinical findings, target expression and target risk input to the clinical protocols, informed consent forms, and monitoring protocols.
• Lead target risk assessments and develop fit-for-purpose plans to screen for and manage potential liabilities of novel targets and therapeutics.
• Develop nonclinical safety strategies for different modalities and/or routes of administration based on an integration of literature, regulatory guidance, and involvement with professional organizations to inform project advancement decisions.
• In issue-resolution teams, provide key contributions to hypotheses generation and leadership to drive rapid and impactful outcomes.
• Use your drug development experience to effectively communicate across all levels with internal and external partners, governance meetings, and meetings with global regulatory authorities. This requires excellent communication and negotiation skills.
• Participate in due diligence activities on potential L&A opportunities