Associate Director of Toxicology

Kelly; Carlsbad (CA); On-site; USD 175,000 - 250,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Telemedicine

Term life

Whole life

Accident insurance

Critical illness

A legal plan

Short-term disability

Retirement savings plan

Service bonus and holiday pay plans (8

Job summary

Kelly Science & Clinical is seeking an Associate Director, Toxicology for a direct hire in the San Diego area. The role leads nonclinical safety strategy across a diverse portfolio of drug candidates and oversees GLP/non-GLP studies, including CRO management.

Onsite presence in Carlsbad, CA is required. You will prepare regulatory submissions, interpret toxicology data, and communicate findings to cross-functional teams and senior decision-makers.

Qualifications

• Advanced degree in Toxicology or related life science.
• Minimum 5 years (Ph.D.) or 8 years (Master’s) in nonclinical safety.
• Experience managing CRO studies and regulatory deliverables (IBs, INDs, CTDs).
• Strong data interpretation and cross-functional communication.

Responsibilities

• Serve as nonclinical safety authority for cross-functional teams.
• Design, oversee, and interpret GLP and non-GLP studies.
• Manage outsourced CRO studies, review protocols and reports.
• Integrate pharmacology, toxicology, pathology data for safety assessments.
• Develop and implement nonclinical strategies for programs.
• Prepare and review nonclinical content for regulatory submissions.

Skills

CRO management

Nonclinical safety

Regulatory docs

Leadership

Communication

Education

Master’s or Ph.D. in Toxicology

Job description

Description
Kelly Science & Clinical is seeking an Associate Director of Toxicology for a direct hire opportunity with one of our clients, a commercial-stage biotechnology company in the San Diego, CA area. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology industry.

Workplace: San Diego Metropolitan area

Position Title: Associate Director, Toxicology

Salary range: 175,000-250,000/ year
Are you ready to help drive innovation at the cutting edge of RNA-targeted medicine and advanced gene technologies? Our client is renowned for pioneering advances in biotechnology, delivering transformative therapies for serious diseases with a growing portfolio of marketed products and an industry-leading pipeline in neurology, cardiology, and other high-impact areas. Financially robust and passionately patient-focused, we are well positioned to continue shaping the future of RNA medicines and gene editing solutions.
A leading commercial-stage biotechnology innovator, headquartered in the vibrant San Diego area, is seeking a skilled and driven Toxicologist to join its dynamic Preclinical Development team. This role offers the unique opportunity to shape the nonclinical safety strategy for a diverse portfolio of transformative drug candidates. The team thrives on scientific rigor, cross-disciplinary collaboration, and a passion for advancing novel therapies. Onsite presence in Carlsbad, CA is required.

Key Responsibilities

• Serve as the nonclinical safety authority for cross-functional project teams, offering strategic guidance to drive candidate selection, risk assessment, and program progression.
• Design, oversee, and interpret both GLP and non-GLP studies focused on nonclinical pharmacology and toxicology, leveraging external partners for execution.
• Directly manage outsourced studies conducted at CROs, ensuring robust study designs, protocol and report review, proactive issue resolution, and adherence to project timelines.
• Synthesize multidimensional nonclinical datasets—including pharmacology, toxicology, clinical pathology, and TK/PK data to generate integrated safety assessments.
• Create and implement regulatory and nonclinical toxicology strategies for assigned programs.
• Prepare and critically review nonclinical content for key regulatory submissions (e.g., Investigator’s Brochures, INDs, NDAs, DSURs), and represent the company in global regulatory interactions.
• Evaluate the significance of safety findings and mechanisms of toxicity, ensuring human relevance and impact on development goals.
• Communicate essential nonclinical safety findings, risk evaluations, and implications to internal teams and governance stakeholders.
• Build effective partnerships with both internal colleagues and external collaborators within a matrixed development framework.
• Represent the organization’s interests externally through engagement with scientific meetings, industry consortia, working groups, and professional societies.
• Make meaningful contributions to peer-reviewed scientific publications.

Qualifications

• Advanced degree (Master’s or Ph.D.) in Toxicology or a related life science discipline.
• A minimum of 8 years (with Master’s) or 5 years (with Ph.D.) of experience in nonclinical safety assessment within the pharmaceutical or biotechnology sector.
• Demonstrated expertise in managing and overseeing CRO-conducted studies, with strong skills in protocol/report development and project management.
• Deep experience in generating, integrating, and interpreting toxicological data to inform program decisions.
• Proven ability to author high-quality regulatory documents, including IBs, INDs, CTDs, and other health authority submissions.
• Strong leadership and communication skills, capable of influencing across matrixed R&D environments and engaging senior decision makers.
• Passion for continuous professional growth and the advancement of toxicology expertise.
• DABT certification is preferred.

Why Join Us:

Be a vital part of a trailblazing team where your contributions are valued and impactful. Embrace the opportunity to innovate in a collaborative and forward-thinking environment, advancing the future of treatment for neurological disorders.

P1

• Medical
• Dental
• Vision
• Telemedicine
• Term life
• Whole life
• Accident insurance
• Critical illness
• A legal plan
• Short-term disability
• Retirement savings plan
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
• Transit spending account
• Paid sick leave under the applicable state or local plan

Why Kelly Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.