Senior Scientist, Study Toxicologist

Insmed Incorporated•NJ Corporate Headquarters, NJ

6d•$133,000 - $173,000•Remote

About The Position

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).

Requirements

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

Nice To Haves

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

Responsibilities

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.

Benefits

Comprehensive medical, dental, and vision coverage and mental health support
Annual wellbeing reimbursement
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match
Annual equity awards
Participation in our Employee Stock Purchase Plan (ESPP)
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
Meaningful opportunities to connect, volunteer, and give back