We are seeking a highly motivated Senior/Principal Scientist with a strong foundation in animal and/or biomedical sciences, including toxicology, pathology and physiology with proficient knowledge of developmental and reproductive biology, to join our Toxicology team. The successful candidate will assess preclinical safety of experimental compounds and will support drug development programs – from lead identification through clinical trial support – in a collaborative team environment, playing a pivotal role at all levels of preclinical development.
- Oversee preclinical toxicology studies at external contract research organizations (CRO), including:
- Facilitate study initiation by executing appropriate processes for contract implementation, test article procurement, protocol development, and timeline commitments.
- Monitor studies for appropriate conduct, accuracy and timely completion; audit raw data for accuracy; and review draft reports for completion.
- Anticipate study problems and opportunities and raise issues with suggested resolutions to supervisor.
- Ensure appropriate project management and oversight with multiple CROs.
- Evaluate individual and programmatic study data (anatomic pathology, clinical pathology, in-life parameters, etc.) as to the potential toxicity of experimental compounds in different animal species and prepare verbal and written summaries for internal discussions.
- Work with the Toxicology team to develop optimal strategies to address specific safety issues and partner with project teams to select and advance Development compounds.
- Serve as a key resource, providing scientific knowledge and expertise to cross-functional project teams.
- Contribute to various regulatory documents and ensure regulatory compliance.
- Build strong collaborative relationships with research and development teams to meet project, departmental, and company goals.
- PhD in Toxicology, Pathology, or related health science field; Board Certification in Toxicology (ABT) strongly preferred, or
- DVM/PhD or DVM
- Solid foundation in animal and/or biomedical sciences, including toxicology, pathology, and physiology with proficient knowledge of developmental and reproductive biology.
- Excellent written and oral communication skills.
- Strong commitment to quality and accountability.
- Data-driven decision-making.
- Strong organizational and project management skills.
- Effective problem solving skills and judgement.
- Able to work in a strong collaborative environment.
- Preferred:In vivo study director experience
- Technical writing proficiency.
- Direct experience with Good Laboratory Practices (CFR 21 Part 58)