Associate Director of Toxicology, Small Molecules

Kelly Services; San Francisco (CA); Hybrid; USD 200,000 - 230,000; Full time

Job summary

Kelly Services is seeking an Associate Director of Toxicology for a clinical-stage biopharmaceutical company in San Francisco. This hybrid role leads nonclinical safety strategies and GLP studies to enable key development milestones.

The ideal candidate holds a Ph.D. in Toxicology or Pharmacology, 10+ years in industry, and proven CRO oversight, regulatory submissions, and cross-functional leadership.

Qualifications

• Ph.D. in Toxicology, Pharmacology, or related field; DABT preferred.
• 10+ years in nonclinical safety/toxicology with drug development experience.
• Expertise in GLP and non-GLP safety studies for IND-enabling and late-stage development.

Responsibilities

• Act as principal nonclinical safety/toxicology expert on cross-functional teams; shape strategies from discovery to clinic.
• Lead design, oversight, and monitoring of GLP toxicology and safety pharmacology studies; manage post-IND investigations.
• Provide scientific oversight for CROs and ensure data quality and regulatory compliance.
• Draft and review nonclinical sections of regulatory documents; support health authority interactions.
• Collaborate with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams.

Skills

Nonclinical safety

Toxicology leadership

GLP/ICH regulations

CRO management

Cross-functional collaboration

Regulatory strategy

Education

Ph.D. in Toxicology/ Pharmacology

DABT preferred

Tools

GLP/ICH regulatory knowledge

Job description

Kelly® Science & Clinical is seeking an Associate Director of Toxicology for an opportunity with one of our clients, a clinical-stage biopharmaceutical company, seeking to redefine pain management. 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: Hybrid 3-days onsite, San Francisco, CA

Position Title: Associate Director of Toxicology

Salary range: $200,000-230,000/year

About the Company

Join one of the leading clinical-stage biopharmaceutical innovators dedicated to redefining pain management through next-generation, non-opioid therapies. With a culture grounded in scientific rigor, patient-centered innovation, and a track record of executive success, we’re seeking talented individuals to transform care for patients living with pain-related conditions. Our team operates at the forefront of breakthrough science in an environment that values creativity, collaboration, and the advancement of meaningful therapeutics.

Associate Director, Nonclinical Safety (Toxicology)

Are you passionate about advancing innovative therapeutics through strategic toxicology leadership? We are seeking an accomplished and driven Associate Director of Toxicology to shape and deliver nonclinical safety strategies that will enable transformative discovery and development programs. This is a high-impact, visible role—perfect for a scientific leader eager to influence program direction across a dynamic portfolio.

Position Highlights

The Associate Director will serve as the principal nonclinical safety/toxicology expert within multidisciplinary teams, driving the strategic design, execution, and interpretation of integrated safety data pivotal to candidate selection and late-stage advancement. You will blend scientific depth with operational acumen, ensuring the highest standards of data integrity, risk assessment, and regulatory alignment.

Key Responsibilities

Strategic Leadership & Program Influence

• Act as primary toxicology expert on cross-functional teams, shaping nonclinical safety strategies from early discovery through clinical development.
• Synthesize and contextualize nonclinical findings to support robust risk-benefit assessments and go/no-go decisions.
• Drive candidate selection and portfolio prioritization through deep scientific insight and collaborative partnership.

Study Design & Operational Excellence

• Lead the design, oversight, and monitoring of exploratory (non-GLP) and IND-enabling GLP toxicology and safety pharmacology studies, as well as post-IND investigations (e.g., sub-chronic, chronic, reproductive, carcinogenicity studies).
• Provide scientific oversight for CROs and external partners, ensuring rigorous execution, high-quality data, and GLP/ICH compliance.
• Proactively address data gaps and implement mitigation strategies in fast-evolving development contexts.

Data Analysis & Program Communication

• Critically analyze and interpret complex nonclinical safety data, translating findings into actionable recommendations for drug development teams and executive stakeholders.
• Present data and strategy with clarity and authority to internal governance bodies and project teams.

Regulatory Strategy & Compliance

• Author and review nonclinical sections of key regulatory documents (INDs, IBs, briefing books, responses to agencies), ensuring clarity, completeness, and alignment with global regulatory expectations.
• Partner with Regulatory Affairs to drive successful health authority interactions (e.g., FDA), maintaining up-to-date knowledge of guidances and requirements.
• Ensure full compliance with GLP, ICH, and other applicable guidelines.

Cross-functional Partnership

• Collaborate closely with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams to deliver seamless and coherent development programs.
• Contribute scientific expertise to integrated project plans and portfolio decision‑making.

Qualifications

• Ph.D. in Toxicology, Pharmacology, or related discipline (DABT highly preferred)
• ~10+ years of industry experience in nonclinical safety/toxicology, with a demonstrated record of advancing small molecule drug development candidates
• Deep expertise in the design, monitoring, and interpretation of GLP and non-GLP safety studies supporting IND-enabling and late-stage development
• Command of GLP/ICH regulations and regulatory toxicology strategy
• Proven experience authoring regulatory submissions and engaging directly with health authorities
• Experience managing CRO relationships and driving data quality in externalized study settings
• Background in pain, neuroscience, or related therapeutic areas is advantageous
• Prior work in early-stage biotech or high‑growth R&D environments preferred

Attributes for Success

• Exceptional scientific judgment, analytical rigor, and creative problem-solving
• Skilled communicator with a talent for translating complex data into impactful strategy and recommendations
• Collaborative, proactive, and highly organized—adept at thriving in cross‑functional, fast‑paced teams

#P1

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work‑related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short‑term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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.

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Kelly Services is proud to be an Equal Employment Opportunity and affirmative action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.