Senior Principal Scientist, Nonclinical Safety Lead

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 Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Principal Scientist, Nonclinical Safety Lead within Preclinical Sciences and Translational Safety (PSTS). This position is a hybrid role and will be located in Spring House, PA. As a Senior Principal Scientist, Nonclinical Safety (NCS) 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 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 L&A opportunities, as needed.
• Collaborate proactively with Chemistry, Manufacturing and Controls (CMC) functions 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.

Requirements

• A minimum of a Master’s degree in Toxicology, Pharmacology or a related discipline is required.
• A minimum of 12 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a Master’s degree or a minimum of 8 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.
• Experience in representing toxicology/nonclinical safety on multi-disciplinary project teams is required.
• Strong understanding of the drug discovery/development process is required.
• The ability to critically evaluate, interpret and integrate large datasets and literature is required.
• Must have excellent oral and written communication skills. 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. Apply tot his job

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