Kelly® Science & Clinical is seeking a Senior Director of Toxicology opportunity with one of our clients, a clinical-stage biopharmaceutical company in the Los Angeles, CA area, 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 in the Los Angeles, CA, or San Francisco, CA areas
Position Title: Senior Director of Toxicology
Salary range: 280,000-350,000/year
Clinical Pharmacology – San Francisco, CA or Thousand Oaks, CA (Hybrid)
Full-Time
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.
Position Overview
The Senior Director, Toxicology will play a pivotal leadership role, setting the vision and driving execution for all aspects of nonclinical safety assessment across a robust research and development pipeline. This influential position will shape nonclinical strategies spanning from early discovery through to IND, clinical development, and NDA stages for pioneering small molecule programs. As the primary subject matter expert in nonclinical safety, you will be integral to cross-functional project teams, regulatory strategy development, and organizational growth—impacting decisions that ultimately advance innovative treatments to patients in need.
Key Responsibilities
Scientific & Strategic Leadership
- Establish and lead the nonclinical safety and toxicology framework, supporting compound progression from earliest discovery through late-stage clinical milestones.
- Serve as a critical advisor and the principal nonclinical safety expert on multidisciplinary teams, integrating data-driven risk-benefit analyses and guiding portfolio strategy.
- Define target safety profiles in partnership with discovery, DMPK, clinical pharmacology, and development colleagues, effectively influencing key candidate selection and development decisions.
Study Design & Execution
- Design, oversee, and interpret complex toxicology and safety pharmacology studies, ensuring scientific rigor, adherence to regulatory timelines, and strategic alignment.
- Provide scientific oversight for external CROs and consultants—reviewing protocols, assessing study integrity, and ensuring robust data generation and reporting.
- Champion optimal staging and resource planning of nonclinical safety programs from concept through IND-enabling and registrational studies.
Regulatory Excellence & Compliance
- Collaborate closely with Regulatory Affairs to drive authorship, review, and approval of nonclinical components of INDs, investigator brochures, briefing documents, and regulatory correspondence.
- Represent nonclinical safety in regulatory agency interactions, including high-stakes meetings spanning development (pre-IND, end-of-Phase 2, pre-NDA).
- Uphold compliance to GLP, ICH, and international regulatory standards—embedding a culture of quality in all nonclinical operations.
Organizational & People Leadership
- Recruit, mentor, and develop a high-performing nonclinical safety team, modeling scientific excellence and promoting a collaborative, innovative culture.
- Contribute to the evolution and refinement of organizational nonclinical safety standards, systems, and best practices, supporting growth and scalability.
- Act as a trusted thought partner to senior R&D leadership—shaping both pipeline and organizational strategy.
Qualifications
- Advanced degree (PhD, DVM, or equivalent) in Toxicology, Pharmacology, or a related discipline.
- Minimum 15 years’ industry experience in nonclinical safety/toxicology within innovative biotechnology or pharmaceutical organizations.
- Extensive leadership of nonclinical safety programs supporting small molecule therapies, spanning IND-enabling through registration stages.
- Strong record of regulatory authorship and agency engagement, with experience supporting early to late-stage programs.
- Demonstrated success leading cross-functional teams and exerting influence on development and portfolio strategies.
- Expertise in pain or neuroscience therapeutic areas is highly desirable.
- Profound scientific expertise in nonclinical safety and toxicology.
- Visionary leadership with strategic and executional acuity.
- Compelling and precise scientific communication.
- Collaborative mind-set and strong people development skills.
- Agility and resilience in a dynamic, fast-paced biotech environment.
