Distinguished Scientist - Nonclinical Safety Leader

Lead PSTS project teams of nonclinical safety and Pharmacokinetic (PK) scientists Ensure efficient information transfer within project teams and interface with senior management Serve as NCS representative for global project teams Provide strategic leadership, toxicology expertise, and matrix leadership for portfolio projects Support progression of portfolio assets from target assessment through commercialization Collaborate with discovery scientists to identify and nominate candidate molecules Create target risk assessments and plans to screen for and mitigate potential risks Analyze toxicology and safety pharmacology studies and prepare nonclinical safety assessments Contribute to issue-resolution teams by generating hypotheses and investigative strategies Manage global regulatory nonclinical documents and health authority responses Participate in medical safety teams, signal detection analyses, and risk mitigation strategies Conduct nonclinical safety risk assessments for Licensing and Acquisition opportunities Collaborate with Chemistry, Manufacturing and Controls (CMC) functions to assure drug substance quality Participate in external academic or industry societies and consortia Maintain scientific depth and knowledge in competitive intelligence and regulatory landscapes Communicate with stakeholders and regulatory authorities Provide leadership and mentorship within the PSTS organization Lead strategic initiatives as required Potentially assume future-facing people leadership responsibilities 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 10 years with a doctoral level degree, is required Proven experience representing toxicology/nonclinical safety on multi-disciplinary project teams Strong understanding of the drug discovery and development process Excellent oral and written communication skills Ability to collaborate with all levels in a cross-functional team environment 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 diverse and emerging/specialized therapeutic modalities is preferred Board certification, e.g. Diplomate of the American Board of Toxicology (DABT), is preferred Core Competencies Demonstrates expertise in toxicology and pharmacokinetics, with a strong background in leading nonclinical safety projects and cross-functional collaboration. Proven ability to manage regulatory documents and communicate effectively with stakeholders and health authorities. Highest-signal resume keywords Toxicology Expertise Pharmacokinetics Knowledge Regulatory Document Management Cross-Functional Team Collaboration Leadership and Mentorship ATS Optimization Keywords Hard Skills Nonclinical Safety Assessments Risk Assessment Creation Drug Discovery Process Understanding Due Diligence Activities Study Director Experience Good Laboratory Practice (GLP) Compliance Signal Detection Analysis Toxicology Study Analysis Portfolio Project Management Candidate Molecule Nomination Soft Skills Excellent Communication Skills Collaborative Teamwork Strategic Leadership Problem-Solving Mentorship Certifications & Qualifications Diplomate of the American Board of Toxicology (DABT) Industry Keywords Pharmaceutical Industry Biotech Industry Nonclinical Safety Pharmacology Toxicology Health Authority Interaction Matrix Leadership Therapeutic Modalities Competitive Intelligence Regulatory Landscapes #J-18808-Ljbffr Jobtailor