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Johnson & Johnson Innovative Medicine R&D seeks a Senior Nonclinical Safety Leader to guide safety strategy from discovery to development. You will lead safety science teams, develop risk assessments, analyze toxicology studies, and draft regulatory safety documents with global partners.
The role emphasizes cross-functional collaboration, regulatory acumen, and leadership across diverse modalities in a hybrid Spring House, PA or Cambridge, MA setting.
Responsibilities: lead project teams of safety scientists, serve as NCS representative on global project teams, develop risk assessments, analyze toxicology studies, prepare regulatory safety documents, support clinical trial and registration activities, and contribute to due diligence and external scientific engagements.
Qualifications: Master’s degree in Toxicology, Pharmacology, or related field required; PhD, DVM, or MD preferred. At least 15 years (Master’s) or 10 years (PhD or equivalent) industry experience, with proven toxicology project leadership in biotech/pharma. Preferred skills include GLP study oversight, diverse modality expertise, and regulatory acumen; board certification (e.g., DABT) advantageous.
HighValue: role spans early discovery to clinical development, supporting investigational drugs in various therapeutic areas; requires cross-functional collaboration with discovery, CMC, regulatory, and external partners.
Location: hybrid in Spring House, PA, or Cambridge, MA.