Kelly® Science & Clinical is seeking an Associate Director, Toxicology, for a direct-hire position at a cutting-edge client in Carlsbad, CA . If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Schedule
Full-Time | On-Site – Carlsbad, CA
Overview
Our Client is an industry-leading company at the forefront of RNA-targeted medicines and drug discovery , with a rich history spanning more than three decades of redefining life for patients with serious diseases. With multiple marketed medicines and a leading pipeline in neurology, cardiology, and select areas of high patient need , our Client continues to drive innovation in RNA therapies while advancing new approaches in gene editing. They are well-positioned financially to deliver on their strategic goals and are building toward what they believe will be their greatest achievements yet.
Responsibilities
- Serve as the nonclinical safety representative on cross-functional project teams, providing strategic toxicology input to support candidate selection, risk assessment, and program advancement
- Design, oversee, and interpret non-GLP and GLP nonclinical pharmacology and toxicology studies
- Manage outsourced toxicology studies at CROs, including study design, protocol and report review, issue resolution, and timeline management
- Drive integrated nonclinical safety assessments by synthesizing pharmacology, toxicology, clinical pathology, and TK/PK data
- Develop nonclinical toxicology and regulatory strategies for assigned programs
- Author and review nonclinical sections of regulatory documents, including Investigator's Brochures, INDs, NDAs, DSURs, and related submissions, and represent our Client in interactions with regulatory authorities
- Assess toxicology findings and mechanisms of toxicity to determine human relevance and development impact
- Communicate key nonclinical safety findings, risk assessments, and development implications to project teams and governance committees
- Partner effectively with internal functional teams and external collaborators to advance programs in a matrixed development environment
- Represent our Client externally through scientific meetings, industry consortia, working groups, and professional societies
- Contribute to scientific publications in high-impact, peer-reviewed journals
Qualifications
- Master's or Doctoral degree in Toxicology or a related life sciences discipline
- At least 8 years (Master's degree) or 5 years (Ph.D.) of experience in nonclinical safety within the pharmaceutical or biotechnology industry
- Experience managing outsourced studies and working with CROs, including protocol and report development or review, as well as timeline management
- Experience generating, integrating, reviewing, and interpreting toxicology data
- Experience authoring regulatory documents such as IBs, INDs, CTDs, and other health authority submissions
- Demonstrated ability to work effectively as a senior individual contributor in a matrixed environment, influencing without direct authority across scientific and functional teams
- Proven ability to convey advanced scientific information and persuade diverse stakeholders, including project teams, senior leadership, and governance committees
- Commitment to lifelong learning and professional development, including building or expanding subject matter expertise
- Preferred: DABT certification, or a strong interest in obtaining DABT certification