We’re looking for a Senior Scientist, Study Toxicologist on the Nonclinical Safety team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Toxicology Study Operations you’ll play a critical role in collaborating with project toxicologists and managing the outsourcing, design, and oversight of safety pharmacology and toxicology studies at contract research organizations (CROs). What You'll Do: In this role, you’ll have the opportunity to coordinate studies, ensure high-quality data, and contribute to regulatory submissions. You’ll also:Collaborate with toxicology project leads and subject matter experts (e.g., discovery, bioanalysis, pharmacokinetics, CMC) to design safety pharmacology and toxicology studies, aligning with company objectives and regulatory standards. Serve as the primary sponsor representative for CROs, handling all aspects of study outsourcing, including requesting quotes, negotiating contracts, and managing study timelines. Oversee the design, execution, and data interpretation of nonclinical safety studies conducted at CROs, ensuring robust and high-quality data generation. Review study reports and SEND datasets to ensure quality, timeliness, and readiness for regulatory submissions. Effectively communicate study findings to toxicology project leads and senior management, addressing and resolving any study-related issues promptly. Contribute to the preparation, review, and/or QC of nonclinical sections in regulatory submission documents (e.g., I - Bs, IN - Ds, CT - As, ND - As, BL - As, MA - As, PI - Ps, Scientific Advice, annual reports, briefing documents) as needed. Participate in issue-resolution teams, providing scientific guidance to address toxicology-related challenges and drive effective problem-solving. Develop and enhance departmental SOPs and best practice documents to improve study operations and ensure regulatory compliance. Who You Are:You have a PhD or an MS and 3 years of toxicology experience or a BS and 5 years of toxicology experience in the pharmaceutical/biotechnology industry or at CROs. You are or you also have:Expertise overseeing safety pharmacology studies. Proven track record of successfully directing and/or monitoring toxicology studies across various modalities, including small molecules, biologics, antisense oligonucleotides, and gene therapies. Advanced knowledge of toxicology in support of drug development. In-depth understanding of GLP regulations and regulatory guidance for nonclinical evaluations. Nice to have (but not required):5 years of hands-on experience as a study director and/or monitor in toxicology. Interest in expanding your experience with general toxicology studies. Demonstrated enthusiasm for scientific research and a commitment to maintaining high-quality standards in toxicology study operations. Strong strategic thinking, critical analysis, and leadership capabilities. Self-motivated to meet performance objectives and to prioritize job-related tasks. Ability to adapt to dynamic project needs and manage studies across different time zones. Excellent interpersonal, communication, and negotiation skills, with a collaborative mindset. Willingness and flexibility to travel on business to CROs. Where You’ll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Travel Requirements.