Job Details

Director, Toxicology

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.

We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.

We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.

About The Role

We are seeking an experienced Toxicologist to join our Translational Development Team. This individual will play a pivotal role on project teams and in steering the strategic direction of the Toxicology function. Your primary responsibility will be to ensure that all safety pharmacology and toxicology studies and programs are conducted in strict accordance with relevant guidelines and regulatory standards. You will oversee the development and implementation of toxicology strategies to support our discovery and development programs, thus contributing significantly to the advancement of our innovative projects.

Responsibilities

• Develop, implement, and direct toxicology strategies, including integrated risk assessments, to support discovery and development programs across multiple disease indications
• Support the planning and execution of Safety Pharmacology and Toxicology studies/data for all programs
• Responsible for toxicology data analysis and interpretation, authoring nonclinical sections for regulatory documents including IND/CTA/IB/NDA
• Oversee and coordinate nonclinical safety evaluations of drug candidates with CROs and consultants to ensure timely completion and delivery of high-quality data and study reports
• Evaluate, interpret, and summarize toxicology results, providing proactive strategic direction to project teams
• Address and resolve non-clinical safety issues arising in drug discovery and development programs and adequately assess the relevance of any toxicological findings to human safety
• Design and initiate exploratory or investigational studies to further characterize safety findings as warranted
• Maintain current knowledge of regulatory guidance, industry standards, and recommendations.
• Maintain a current understanding of modern methods for toxicological risk assessment, including in vitro, in vivo, and in silico approaches through literature review, scientific conferences, and interactions with advisors and key opinion leaders.

Qualifications

• V.M or PhD in Toxicology, Pathology, or closely related discipline, with 8+ years of pharmaceutical or biotech experience.
• Demonstrated experience in serving as the toxicology lead on cross-functional drug development teams
• Expert knowledge of designing exploratory and definitive toxicology studies and conducting risk assessments to support small molecule drug development strategies
• Knowledge of FDA, EMA, and ICH guidance documents and GLP regulations
• Demonstrated experience in the preparation of INDs, CTAs, NDAs, and/or MAAs.

The anticipated salary range for candidates who will work in South San Francisco, CA is $230,000 - $250,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.