Insmed is a global biopharmaceutical company dedicated to creating life-transforming therapies for patients with serious and rare diseases that have limited tre
Senior Scientist, Study Toxicologist
Location
United States
Posted
9 days ago
Salary
$133K - $173K / year
Seniority
Senior
Job Description
Senior Scientist, Study Toxicologist
Insmed
Role Description 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: - 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. Qualifications - 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. - 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. Requirements - 5+ years of hands-on experience as a study director and/or monitor in toxicology (nice to have but not required). - 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. Benefits - 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. Company Description 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.
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