Senior Toxicologist: Drug Safety & Regulatory Strategy

BioPhase Inc.; San Diego (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

BioPhase Inc. seeks a Project and Regulatory Toxicologist to guide safety assessment and interpret in vitro/in vivo studies for covalent and non-covalent targeted small molecules. You will work with toxicology, CROs, and cross-functional teams to advance therapeutics to the clinic.

Essential duties include leading toxicology strategy, managing CRO studies, and contributing to regulatory documents while keeping abreast of evolving safety requirements through industry collaborations.

Qualifications

• Ph.D. with 6+ years of industry experience or MS with 10+ years
• ABT Diplomate highly desired
• Broad understanding of nonclinical safety and regulatory requirements
• Experience representing toxicology on discovery and development teams
• Experience with in vitro and in vivo safety studies is required
• Experience working with CROs

Responsibilities

• Represent the toxicology function as SME on drug discovery teams
• Interface with CROs to plan and oversee in vitro/in vivo studies
• Contribute to safety study summaries and regulatory documents
• Stay current with regulatory requirements through consortia or conferences
• Collaborate with early discovery teams for safety derisking

Skills

Interpersonal skills

Verbal and written communication

Problem solving

Agile mindset

Team collaboration

Education

Ph.D. in pharmacology/toxicology or related

M.S. in pharmacology/toxicology or related

ABT Diplomate (desired)

Job description

BioPhase Inc. seeks a Project and Regulatory Toxicologist to guide safety assessment and interpret in vitro/in vivo studies for covalent and non-covalent targeted small molecules. You will work with toxicology, CROs, and cross-functional teams to advance therapeutics to the clinic.

Essential duties include leading toxicology strategy, managing CRO studies, and contributing to regulatory documents while keeping abreast of evolving safety requirements through industry collaborations.