Principal Scientist/Sr. Principal Scientist, Toxicology

Role Summary

As a scientific leader, develop and lead Toxicology/Safety Pharmacology projects from planning through to final reporting. Participate in formulating the strategic and operational direction of the function, ensuring all studies are conducted in line with guidelines and regulatory testing standards and individual program objectives. Recommend scientific strategies for overall programs and/or department. Represent Toxicology on Development teams and may advise senior technical leadership of Toxicology/Safety Pharmacology findings and recommendations.

Responsibilities

• Participates in formulating toxicology strategies and leads the execution in order to develop and implement plans for nonclinical safety testing of new and current drug candidates
• Designs, evaluates and implements protocol preparation for assigned Toxicology and Safety Pharmacology studies. Manages the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre-study activities, and approving study protocols and reports
• Continuously performs extensive analyses/interpretations of Toxicology/Safety Pharmacology data, prepares clear technical reports and oral presentations, and serves as a key opinion leader(s) making a go/no-go decision
• Authors and/or reviews Toxicology/Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA (BLA)/MAA submissions
• Owns preparation of documents and annual investigational new drug and new drug application reports
• Independently performs quality control checks on Toxicology/Safety Pharmacology documents for regulatory submission
• Drives the identification, evaluation, selection and management Toxicology/Safety Pharmacology CROs, act as technical expert and ensure CROs have sufficient capabilities, resources to executes against contractual obligations
• Proactively recommends and drives process optimizations and SOP changes as needed to guide the Toxicology/Safety Pharmacology programs
• Proactively researches and stays current with regulatory guidance, keeping key stakeholders aware of potential changes
• Works collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teams
• May provide support to build and maintain technical databases, archives and department procedures manuals
• Direct and oversees junior level scientists and/or team members
• Will lead the development of intellectual property

Qualifications

• DABT certification is desirable
• Strong expertise in Safety Pharmacology, Toxicology, Pathology or other related specialization
• Demonstrated oversight of toxicology/Safety Pharmacology programs for small molecules, peptides/peptide conjugates, and/or biologics including monoclonal and bispecific antibodies; knowledge in gene therapy is desirable
• Expert and current knowledge of ICH and FDA guidance
• Experience with preparation of regulatory documents (IB, IND, CTA, NDA/BLA, MAA)
• Emerging as an internal thought leader with technical and/or business expertise
• Applies in-depth knowledge of own area of expertise to solve problems
• Applies expertise to manage critical projects and/or relationships
• Integrates analysis of business objectives and strategic direction to resolve problems and recommend solutions
• Has input into short-term strategy and may be involved in long-term strategy on a functional level
• Excellent ability to communicate effectively both orally and in writing in an interdisciplinary environment
• Demonstrated technical leadership experience in managing preclinical Contract Research Organizations
• Proactive, innovative, with exceptional problem-solving, analytical thinking, and influencing skills
• Demonstrated experience working in a cross functional team and matrix environment

Education

• BS/BA in Toxicology, Pharmacology, Biology or related discipline required; 15+ years of CRO and/or pharmaceutical industry experience. Experience in small molecules, peptides/peptide conjugates, and/or biologics including monoclonal and bispecific antibodies. Technical leadership experience in managing preclinical Contract Research Organizations. Experience with preparation of INDs, CTDs, NDAs, and MAAs
• MS/MA in Toxicology, or related discipline and 13+ years of similar experience noted above OR
• PhD in Toxicology or related discipline and 7+ years of similar experience noted above