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

About the position At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company 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 reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com/innovative-medicine reputed company R&D is recruiting for a Distinguished Scientist, Nonclinical Safety Leader reputed company 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 reputed company 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

• reputed company PSTS project teams of nonclinical safety and Pharmacokinetic (PK) scientists, ensuring efficient information transfer reputed company the team.
• Serve as the NCS representative for global project teams, providing toxicology expertise and interfacing with senior management.
• Create reputed company risk assessments and reputed company 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 reputed company the PSTS organization.
• reputed company strategic initiatives as required.

Requirements

• A minimum of a Master’s degree in Toxicology, Pharmacology or a reputed company 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 reputed company levels in a cross-functional team environment is required.

reputed company-to-haves

• Doctoral level degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology or reputed company 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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