SENIOR DIRECTOR, TOXICOLOGY
About The Position
Calibr-Skaggs Institute for Innovative Medicines was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Calibr-Skaggs is a division of Scripps Research, a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Scripps Research is ranked the most influential institution in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading-edge scientists. Leveraging the unique scientific environment of Scripps Research, impacting translational sciences, Calibr-Skaggs has created a portfolio of drug candidates, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while reinvesting in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Calibr-Skaggs’ drug development portfolio spans a broad range of human diseases, including cancer, autoimmunity and inflammatory diseases, metabolic and cardiovascular diseases, infectious and neglected tropical diseases, as well as age-related and degenerative diseases. If you have a passion for making a difference, this could be your opportunity to join our transformative team. The Senior Director of Toxicology will be the primary toxicology expert across our pipeline, driving the design, execution, and interpretation of nonclinical safety programs from early discovery through IND filing and into clinical development. The successful candidate will integrate toxicology strategy into the broader drug development framework, working in close partnership with Chemistry, Biology, DMPK, CMC, Regulatory, and Clinical teams.
Requirements
- PhD. in Pharmacology, Toxicology, Pharmaceutical Sciences, Cell Biology, or a closely related field.
- Diplomate of the American Board of Toxicology (DABT) certification
- 10+ years of experience in a pharmaceutical or biotechnology industry setting, with demonstrated expertise across early- to late-stage drug development.
- Deep understanding of regulatory expectations for preclinical development, including IND submission requirements and global regulatory agency standards (FDA, EMA, ICH).
- Strong working knowledge of GLP regulations and their application in preclinical and early clinical development.
- Proven experience managing multiple CROs and outsourced toxicology programs.
- Track record of successfully contributing to IND filings and regulatory submissions.
- Excellent communication skills with the ability to distill complex toxicology data for cross-functional and executive audiences.
- Experience with diverse therapeutic modalities (small molecules, biologics, or other emerging platforms).
- Experience authoring or contributing to regulatory submissions for IND and beyond.
Responsibilities
- Design, oversee, and interpret toxicology studies across a range of modalities, including in vitro and in vivo safety assessments, to inform candidate selection, dose selection, and clinical translation.
- Integrate nonclinical safety data across disciplines to support program decision-making, risk assessment, and go/no-go recommendations.
- Partner cross-functionally with Chemistry, Biology, DMPK, CMC, Regulatory, and Clinical teams to ensure cohesive and efficient program advancement.
- Serve as a key contributor to IND filings, regulatory authority interactions, and overall development strategy, providing expert interpretation of safety data in the context of regulatory expectations.
- Oversee and manage multiple contract research organizations (CROs) supporting outsourced toxicology studies, ensuring scientific quality, adherence to timelines, and budget accountability.
- Stay current with evolving regulatory guidance, scientific literature, and industry best practices in nonclinical safety and toxicology.
- Represent the toxicology function in internal program team meetings, governance reviews, and external partner meetings.
Benefits
- Eligible for both Short‑Term (STIP) and Long‑Term (LTIP) Incentive Bonus programs, offering a highly competitive total rewards package.
- Employer Contributed Retirement Plan – Depending on eligibility, employees receive an employer contributed retirement plan (no employee contribution required) and the option to contribute to a 403(b) (which is similar to a 401(k) using your own pre or post-tax dollars)
- Full Suite of Health and Welfare plans including three medical plan options (including an HSA available option), dental, vision, life insurance, disability, EAP and more
- Access to Flexible Spending Accounts (Medical/Dependent Care)
- Competitive vacation and sick leave policies
- Free, on-site parking
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
