Director, Toxicology

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: As a key member of the Nonclinical Safety organization, the Director, Toxicology will play a critical role in bridging global nonclinical strategy with local regulatory execution. Reporting directly to the Global Head of Toxicology and Molecular Mechanisms in Bridgewater, New Jersey, and indirectly to the Head of Regulatory Affairs in Tokyo, you will serve as the primary nonclinical subject matter expert supporting regulatory interactions in Japan. In this strategic leadership role, you will collaborate with global team to shape nonclinical safety strategies, oversee outsourced nonclinical activities, contribute to regulatory submissions of nonclinical data, and engage directly with Japanese regulatory authorities on behalf of the global team. This position is based in Tokyo, Japan. What You'll Do: Serve as the primary nonclinical subject matter expert, partnering closely with global nonclinical colleagues in the U.S. and the local regulatory affairs team in Japan. Contribute to the development and implementation of nonclinical safety strategies across programs in the company portfolio and participate in global regulatory interactions as appropriate. Author and/or critically review nonclinical sections of regulatory submissions to the Japanese authority (e.g., CTNs, J-NDAs, briefing books for PMDA consultation, responses to PMDA queries) and support preparation for scientific advice meetings (e.g., PMDA consultation, PMDA preliminary meeting, meeting with MHLW for orphan drug designation). Represent the nonclinical function in regulatory meetings with Japanese authorities; address inquiries and guide scientific discussions on nonclinical data in collaboration with the global team. Oversee and monitor nonclinical activities that are outsourced to contract research organizations in Japan, as appropriate. Conduct impurity safety assessments and provide cross-functional guidance to support CMC processes and regulatory filings in Japan. Help refine departmental SOPs and best practices to enhance operational efficiency and maintain high-quality standards. Maintain up-to-date knowledge of scientific and regulatory developments in safety pharmacology and toxicology. Who You Are: Ph.D., DVM, or equivalent degree in Toxicology or a related field; DABT or JCVP certification strongly preferred. At least 15 years of experience as a regulatory toxicologist (e.g., study director/monitor or project toxicologist) in the pharmaceutical or biotechnology industry. Deep understanding of safety pharmacology, drug metabolism and pharmacokinetics, and toxicology. Proven track record of leading toxicology programs through multiple stages of drug development; experience with small molecules, protein biologics, oligonucleotides, and gene therapies is highly desirable. Strong knowledge of GLP regulations and global nonclinical evaluation guidelines, including regional regulatory expectations. Strategic thinker with strong scientific judgment, problem-solving ability, and decision-making skills. Demonstrated leadership skills with the ability to influence and collaborate across functions and geographies. High degree of adaptability and comfort working across multiple time zones. Excellent interpersonal, communication, and presentation skills. Willingness to travel domestically ... (truncated, view full listing at source)