Associate Director

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 #J-18808-Ljbffr