Senior Scientist, Study Toxicologist

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: 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., IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, 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 This role requires occasional domestic travel (approximately 20%) #LI-REMOTE #LI-MC1 Pay Range: $133,000.00-173,000.00 Annual Life at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at View email address on click.appcast.io and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled. For New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review. If you are an applicant for this role and a New York City resident, you have the right to request: A reasonable accommodation, if one is available under applicable law, by emailing View email address on click.appcast.io; and/or An alternative selection process by emailing View email address on click.appcast.io. Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at View email address on click.appcast.io. Insmed is a people-first global biopharmaceutical company driven to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, NJ, with locations across the U.S., EMEA, and Japan, we’re guided by our core values and a shared commitment to patients and each other. We’ve been named Science’s No. 1 Top Employer four years in a row, certified as a Great Place to Work in the U.S., and recognized among The Sunday Times’ and BioSpace’s Best Places to Work. For patients, each other, and the future of science, we’re in. Are you? Wherever you are in the world or in your career, we want to stay connected. Sign up for our talent community to hear about new career opportunities, company news, and how our teams around the world are striving to make a difference for patients every day. 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