POSITION TITLE: Senior Director, Toxicology
POSITION SUMMARY: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.
RESPONSIBILITIES AND DUTIES:- 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
- Details of established essential functions for this position will be addressed/discussed during the interview process.
POSITION 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
- Proven experience managing multiple CROs and outsourced toxicology programs
- Track record of successfully contributing to IND filings and regulatory
- Excellent communication skills with the ability to distill complex toxicology data for cross-functional and executive
- Experience with diverse therapeutic modalities (small molecules, biologics, or other emerging platforms).
- Experience authoring or contributing to regulatory submissions for IND and beyond
COMPREHENSIVE BENEFITS INCLUDE: - 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
COMPENSATION: The expected hiring range for this position is $230,000 TO $280,000/annually per year, commensurate with experience. Consideration will be given to experience that exceeds the listed requirements.
The above statements describe the level of work performed and expected in general terms. The statements are not intended to list all the responsibilities, duties and/or skills required of employees so classified, and the content herein is subject to change due to the business needs of Scripps Research, with or without notice. Furthermore, nothing in this job description shall be interpreted to be in conflict with or to eliminate or modify in any way the employment-at-will status of Scripps Research staff.
