Scientist II, Discovery Toxicology
Ikena Oncology is a targeted oncology company that discovers and develops biomarker-driven therapies for cancer patients who need life-saving treatment, by understanding what drives their disease. Ikena is advancing five clinical, preclinical, and discovery programs and has a global strategic collaboration with Bristol Myers Squibb. We have raised capital from top tier investors OrbiMed Advisors and Atlas Ventures and recently announced the closing of a $120M in an oversubscribed Series B financing.
We are seeking a highly motivated toxicologist to join our Nonclinical Safety team to provide safety assessments for novel compounds from early-stage Discovery projects to IND submissions. This person will work closely with Discover project teams to conduct in vitro and in vivo toxicology screening studies to help select development candidates and provide target safety assessments to guide selection of potential therapeutic targets. In addition, this person will assist in the conduct of IND enabling toxicity studies and in writing the safety assessment for regulatory submissions. This position will report directly to the Sr. Vice President of Nonclinical Safety. You will work with multidisciplinary teams to set regulatory strategy for nonclinical development and de-risking activities, author regulatory submissions, and oversee externally conducted GLP toxicology studies.
- Provide toxicology representation on interdisciplinary Discovery project teams
- Successfully collaborate with DMPK, Chemistry, Biology, Pharmacology, and Translational teams to provide target safety assessment on novel therapeutic targets
- Coordinate the design, execution, interpretation, and reporting of toxicity screening assays (performed externally with CROs) and provide the risk assessment used to select a drug candidate
- Participate in strategic planning of investigational and regulatory toxicity and pharmacology studies in support of clinical development programs
- Provide critical review and data interpretation of regulatory toxicology studies conducted by CROs to guide portfolio decision making
- Ph.D. in toxicology, molecular biology, or closely related field with 2+ years of experience in pharmaceutical drug discovery and/or development
- Knowledge of cellular pathway mechanisms and molecular toxicology
- Must possess good communications and technical writing skills
- Ability to work independently within a matrixed team environment
- Ability to distill multiple data sets from multiple toxicology studies and species and produce a concise safety assessment narrative internal presentation and regulatory submissions
- Experience with FDA/ICH regulatory guidelines relevant to nonclinical development desired
Personal attributes: team oriented, goal-driven, organized, highly collaborative, open-minded, data-driven, creative, persistent in the face of obstacles and uncertainty, flexible, self-aware of strengths and weaknesses, objective in the evaluation of data and strongly optimistic about overcoming obstacles.