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

• 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

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.

• Toxicology Expertise
• Pharmacokinetics Knowledge
• Regulatory Document Management
• Cross-Functional Team Collaboration
• Leadership and Mentorship

• 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

• Excellent Communication Skills
• Collaborative Teamwork
• Strategic Leadership
• Problem-Solving
• Mentorship

• Diplomate of the American Board of Toxicology (DABT)

• Pharmaceutical Industry
• Biotech Industry
• Nonclinical Safety
• Pharmacology
• Toxicology
• Health Authority Interaction
• Matrix Leadership
• Therapeutic Modalities
• Competitive Intelligence
• Regulatory Landscapes