Project & Regulatory Toxicologist

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

The Project and Regulatory Toxicologist will be expected to use his/her toxicology expertise to guide safety assessment, design, and interpret in vitro/in vivo studies to evaluate the safety profiles of our covalently and non-covalently targeted small molecules according to regulatory guidelines. You will work closely with the toxicology function, CROs, and multidisciplinary drug discovery/development teams to progress promising therapeutics to the clinic.

Essential Duties and Responsibilities

• Represent the toxicology function as a subject matter expert on drug discovery and development project teams, and provide guidance on the safety characterization, prioritization, and advancement of drug candidates
• Directly interface with CROs to place appropriate in vitro and in vivo toxicology studies in a timely manner; manage and oversee the execution of toxicology studies at CROs to ensure high-quality data delivery; review and QC study protocols, results, and study reports; summarize toxicology study results and communicate findings to project teams and senior management accurately and punctually
• Contribute to the writing of safety study summaries, nonclinical overviews, and other regulatory documents; represent the company at regulatory interactions
• Identify and implement new strategies on safety assessment to address current and future safety-related challenges as needed; keep abreast of current regulatory requirements by participating in cross-industry consortia or scientific conferences
• Collaborate with early discovery project teams to conduct literature-based target safety assessments and provide guidance on target safety derisking activities

Education and Experience Requirements

• Ph.D. in pharmacology, toxicology, or a closely related biomedical discipline with 6+ years of industry experience, or M.S. in the above field with 10+ years of industry experience
• Diplomate of the American Board of Toxicology is highly desired
• A broad understanding of various aspects of nonclinical safety assessment and regulatory requirements for drug development; experience representing the toxicology function on discovery and development teams is required; expertise in immunology is highly desired
• Must be able to critically evaluate, interpret, and integrate multidisciplinary data to support target and compound safety assessment and mechanistic derisking
• Experience in the design, conduct, and data interpretation of in vitro and in vivo safety pharmacology, genetic toxicology, and general toxicology studies is required
• Experience working with CROs

Required Key Attributes

• Excellent interpersonal skills, with the ability to interact professionally and effectively in a dynamic, multidisciplinary, and highly collaborative team environment
• Excellent verbal and written communication skills
• Solid problem-solving skills with a strong sense of urgency and scientific curiosity
• Proactive and agile, with the ability to operate in a fast-paced work setting
• Solution- and result-oriented with attention to detail