Director/Senior Director, Toxicology

As a Senior Leader in our organization, you will play a pivotal role 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 set forth by esteemed bodies such as the FDA, WHO, GLP, and ISO. 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 in a variety of disease indications.

• Support the planning and execution of Safety Pharmacology and Toxicology studies/data for all programs.

• 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 and senior management regarding their potential impact on Program and Clinical/Regulatory strategy.

• 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. Develop research strategies designed to understand toxicologic mechanism-of-action when warranted.

• Advise and direct the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.).

• Represent Nonclinical Development on discovery and development-stage program teams.

• Provide strategic oversight and direction for the preparation of data summaries and contribute to the presentation of results to peers, colleagues, and management.

• Oversee and drive the preparation of SOPs as needed to guide functional activities and ensure adherence to SOPs.

• Ensure adherence of regulatory toxicologists to all Toxicology SOPs.

• Maintain current knowledge of regulatory guidance, industry standards, and recommendations.

• Participate in the selecting, developing, and evaluating personnel to ensure efficient operation within the toxicology group.

• 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.

• Undertake other tasks as assigned to meet organizational needs.

Qualifications

• PhD in Toxicology, Pathology, or closely related discipline, with 12+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations, or D.V.M. with 8+ years of similar experience. Experience in toxicologic pathology is beneficial.

• Demonstrated experience in strategy development and implementation within areas of responsibility.

• Expert knowledge of drug development strategies for small molecules, and regulatory regions including US, Canada, Europe, and Japan.

• Expert knowledge of toxicologic pathology is beneficial.

• Expert knowledge of managing clinical Contract Research Organizations (CRO's).

• Demonstrated experience in the preparation of INDs, CTAs, NDAs, and MAAs.

The anticipated salary range for candidates who will work in South San Francisco, CA is $230,000 - $265,000. 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.