TOXICOLOGY
Senior Scientist / Associate Director / Director

Function:  Toxicology
Location:  San Mateo, CA

Company Description
Terns Pharmaceuticals is a global biotechnology company committed to discovering and developing molecularly-targeted, oral, small molecule medicines to treat liver disease and cancer.  Based in San Mateo and Shanghai, Terns Pharma is focused on bringing forward innovative therapeutic candidates with the potential to address significant unmet medical needs in China and globally. The company combines expertise in disease biology and medicinal chemistry with a capital-efficient drug discovery model and extensive clinical development capabilities in China to advance its growing pipeline of medicines.

Position Overview
We are seeking a talented and highly motivated individual to provide toxicology expertise for the development of our small-molecule drug candidates.  The role will include contributions to programs from late stage discovery through all phases of clinical development.  The successful candidate will contribute to the strategic development of our candidates by designing, implementing, and interpreting toxicology studies, and reporting data appropriately.  Specific job title will be commensurate with the candidate’s experience and qualifications.

Responsibilities:

  • Serve as toxicology representative on cross-functional teams at various stages, including late discovery through all phases of clinical development.

  • Simultaneously manage toxicology studies for multiple programs.

  • Interpret data within the context of project goals, and advise project teams accordingly.

  • Communicate cross-functionally to efficiently achieve team and company goals.

  • Work closely with CROs to obtain competitive quotes, coordinate execution of studies and written reports, and provide oversight.

  • Prepare study summaries, protocols, study reports, and other documents to support objectives of project teams.

  • Contribute to regulatory filings such as INDs and NDAs, including writing and coordinating toxicology sections.


Desired Skills and Experience:

  • D. in toxicology, or advanced degree in a related field with appropriate industry experience.

  • At least 5 years of experience in toxicology in a pharma or biotech company.

  • Prior experience should include design and execution of GLP toxicology programs to support IND, safety pharmacology studies, chronic toxicity studies, and carcinogenicity studies.

  • Experience in partnering with clinical development teams to oversee the design and interpretation of safety analyses for small-molecule investigational agents.

  • Strong understanding of FDA, EMA, and ICH guidelines and GLP regulations.

  • Broad knowledge of drug discovery and development processes and challenges.

  • Strong written and verbal communication skills.