Principal Scientist/Sr. Principal Scientist, Toxicology

Role Summary

Principal Scientist/Sr. Principal Scientist, Toxicology role leading Toxicology/Safety Pharmacology projects, overseeing studies from planning through final reporting, and guiding strategic and operational direction within the function.

Responsibilities

• Participates in formulating toxicology strategies and leads execution to develop and implement plans for nonclinical safety testing of new and current drug candidates
• Designs, evaluates and implements protocol preparation for Toxicology and Safety Pharmacology studies; manages conduct and reporting of studies, including study placement, contract development/budgeting, coordination of pre-study activities, and approving study protocols and reports
• Performs extensive analyses/interpretations of Toxicology/Safety Pharmacology data; prepares technical reports and presentations; serves as a key opinion leader for go/no-go decisions
• Authors and/or reviews Toxicology/Safety Pharmacology sections of regulatory documents (IND, CTA, IB, annual report, NDA/BLA/MAA)
• Owns preparation of documents and annual investigational new drug and new drug application reports
• Performs quality control checks on Toxicology/Safety Pharmacology documents for regulatory submission
• Drives identification, evaluation, selection and management of Toxicology/Safety Pharmacology CROs; acts as technical expert to ensure CRO capabilities and contract obligations are met
• Recommends and drives process optimizations and SOP changes to guide programs
• Stays current with regulatory guidance and informs stakeholders of potential changes
• Collaborates with other scientists and technicians as part of multidisciplinary project teams
• Provides support to build/maintain technical databases, archives and department procedures manuals
• Directs and oversees junior level scientists and/or team members
• Leads development of intellectual property

Qualifications

• BS/BA in Toxicology, Pharmacology, Biology or related field; 15+ years CRO/pharmaceutical industry experience; experience with small molecules, peptides/peptide conjugates, and/or biologics including monoclonal and bispecific antibodies; experience with INDs, CTDs, NDAs, and MAAs
• MS/MA in Toxicology or related field; 13+ years of relevant experience
• PhD in Toxicology or related field; 7+ years of relevant experience
• DABT certification desirable
• Strong expertise in Safety Pharmacology, Toxicology, Pathology or related specialization
• Experience overseeing Toxicology/Safety Pharmacology programs for small molecules, peptides/conjugates, and/or biologics; gene therapy knowledge desirable
• Current knowledge of ICH and FDA guidance
• Experience with regulatory documents (IB, IND, CTA, NDA/BLA, MAA)
• Internal thought leadership with technical/business expertise
• Ability to solve problems using in-depth knowledge of their area
• Ability to manage critical projects/relationships and align with business objectives
• Strategic input at short-term and functional long-term levels
• Excellent written and verbal communication in an interdisciplinary environment
• Technical leadership experience in managing preclinical CROs
• Proactive, innovative with strong problem-solving, analytical thinking, and influencing skills
• Experience working in cross-functional/matrix environments

Skills

• Safety Pharmacology
• Toxicology
• Pathology
• Regulatory strategy and documentation
• Project management and CRO management
• Technical leadership and cross-functional collaboration
• Data analysis and interpretation
• Communication and presentation of scientific findings

Education

• BS/BA in Toxicology, Pharmacology, Biology or related field
• MS/MA or PhD in Toxicology or related field (preferred)