Distinguished Scientist (Director), Nonclinical Safety Leader (3 Positions)

About the position 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/innovative-medicine Johnson & Johnson Innovative Medicine R&D is recruiting for a Distinguished Scientist, Nonclinical Safety Leader within Preclinical Sciences and Translational Safety (PSTS). This position is a hybrid role and will be located in Spring House, PA. As a Distinguished Scientist, Nonclinical Safety (NCS) Leader, 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 to bring these molecules to humans and ultimately 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 and Acquisition (L&A) opportunities.
• Collaborate proactively with Chemistry, Manufacturing and Controls (CMC) functions to assure drug substance quality.
• Actively participate in external academic or industry societies and consortia to enhance toxicology strategies and capabilities.
• 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.
• Provide leadership and mentorship within the PSTS organization.
• Lead strategic initiatives as required.

Requirements

• A minimum of a Master’s degree in Toxicology, Pharmacology or a related discipline is required.
• A minimum of 15 years of relevant pharmaceutical/biotech industry experience with a Master’s degree or a minimum of 10 years of relevant pharmaceutical/biotech industry experience with a doctoral level degree (PhD, DVM, MD or equivalent) is required.
• Proven experience in representing toxicology/nonclinical safety on multi-disciplinary project teams is required.
• Strong understanding of the drug discovery and development process is required.
• Must have excellent oral and written communication skills.
• The ability to collaborate with all levels in a cross-functional team environment is required.

Nice-to-haves

• Doctoral level degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology or related discipline is preferred.
• Experience in conducting due diligence activities is preferred.
• Previous experience as a Study Director/Study Monitor under Good Laboratory Practice (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.

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