Calithera is seeking a Senior Scientist, Toxicology to oversee the in vivo evaluation of our novel small molecule oncology pipeline. The role requires broad experience in the development of small molecule anti-cancer treatments with relevant experience designing and implementing GLP toxicology studies in support of regulatory filings. The ideal candidate will be adept at interacting with various groups both within the company and external to the company.
Duties and Responsibilities
- Oversee the non-clinical toxicology and safety pharmacology for the Company’s small molecule programs at all stages of development from early discovery through NDA.
- Design and manage the conduct of GLP toxicology studies at CROs.
- Write and/or review relevant portions of INDs, IBs, NDAs and other regulatory documents as needed to support program development.
- Work independently to identify key experimental questions and solve experimental problems.
- Critically analyze data, provided data summaries for project team and senior management team, and recommend strategic and/or tactical adjustments based on the data when warranted.
- Be a key member of the multi-disciplinary research project teams.
- Independently design and execute experimental strategies to investigate drug and target-related toxicities and mechanisms of action.
- Be accountable for the preparation of documents for regulatory filings and interactions with partners and collaborators.
Qualification and Requirements
- Advanced degree (Ph.D.) in pharmacology, toxicology or related discipline.
- Experience in the pharmaceutical industry (minimum of 2 years); oncology drug development experience strongly preferred.
- Ability to work with interdisciplinary teams.
- Excellent verbal and written language skills.
- Excellent organizational and time management skills.
- Experience with managing studies conducted at CROs.
Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Interested candidates should submit their resume to email@example.com