Senior Director, Nonclinical Safety Evaluation

Provide direct and matrix management to a high-performing team of Toxicologists and Pathologists, fostering innovation, collaboration, excellence, and continuous learning.,Provide integrated strategic leadership for Toxicology and Pathology in support of nonclinical safety evaluation across therapeutic areas.,Apply in-depth knowledge of nonclinical safety disciplines (e.g., general toxicology, safety pharmacology, genotoxicity, developmental and reproductive toxicology, and carcinogenicity).,Evaluate complex nonclinical safety challenges and direct the development of 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 accountable for toxicology assessments supporting extractable/leachable and contaminant risk assessments or impurity qualification.,Serve as a key scientific contributor in regulatory agency interactions, internal governance, and leadership meetings.,Apply expert scientific and regulatory writing experience for critically reviewing, editing, and authoring submission application documents (INDs, CTAs, BLAs, MAAs) and health authority interaction documents.,Oversee the preparation and presentation of nonclinical safety data for various internal and external stakeholders.,Maintain extensive scientific awareness and presence internally and externally through publications, presentations, and engagement with scientific communities.,Serve as an independent contributor for select discovery and/or pipeline programs as a Toxicology Lead.

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

PhD

Employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. Moderna is unable to sponsor non-U.S. persons to apply for an export control license.