Senior Director, Nonclinical Safety Evaluation

Provide direct and matrix management to a high-performing team of Toxicologists and Pathologists.,Offer integrated strategic leadership for Toxicology and Pathology in nonclinical safety evaluation, spanning discovery to post-marketing.,Apply deep knowledge of how nonclinical safety disciplines integrate across the business.,Evaluate complex non-clinical safety challenges and develop innovative solutions.,Provide strategic oversight and guidance to team members on developing scientifically sound nonclinical safety strategies.,Accountable for the design, execution, critical analysis, and reporting of GLP/non-GLP nonclinical safety in vitro and/or in vivo studies.,May be responsible for toxicology assessments supporting extractable/leachable, contaminant risk, and impurity qualification.,Serve as a key scientific contributor in regulatory agency interactions, internal governance, and leadership meetings.,Utilize expert scientific and regulatory writing skills for authoring and reviewing submission documents (INDs, CTAs, BLAs, MAAs) and health authority interaction documents.,Oversee the preparation and presentation of nonclinical safety data for various stakeholders.,Maintain extensive scientific awareness through publications, conference presentations, and engagement with the scientific community.,Act as an independent contributor for selected discovery and/or pipeline programs as a Toxicology Lead.

PhD.,11 or more years overseeing aspects of nonclinical safety assessment activities in pharmaceutical development.,Experience in nucleic acid-based and nanoparticle modalities, immune-modulating therapeutics, oncology, and/or infectious disease vaccine drug development is strongly considered.,Experience serving in and/or managing colleagues in a Toxicology representative role on drug development programs.,Experience designing and executing nonclinical toxicology strategies and GLP/non-GLP studies.,Experience in mentoring, coaching, and/or managing others.,Experience applying regulatory guideline knowledge in nonclinical safety studies to support regulatory filings.,Direct experience writing, reviewing, and critiquing nonclinical sections of regulatory submission documents and interacting with regulatory agencies.

PhD

Must be a U.S. person (citizen, permanent resident, asylee, or refugee) due to U.S. export control laws.,Work in a smoke-free, alcohol-free, and drug-free environment.