Senior Scientist, Study Toxicologist

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

 

Consistently Ranked Science’s Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

  

 

 

A Certified Great Place to Work®

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

  

 

Overview

The Senior Scientist, Study Toxicologist, is a pivotal member of the Nonclinical Safety team, reporting to the Associate Director, Toxicology Study Operations. You will play a critical role in collaborating with project toxicologist and managing the outsourcing, design, and oversight of safety pharmacology and toxicology studies at contract research organizations (CROs). This position requires a strategic and detail-oriented professional who can effectively coordinate studies, ensure high-quality data, and contribute to regulatory submissions. This position is located at our headquarters facility in Bridgewater, New Jersey.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

• 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.

About You:

• PhD with a minimum of 5 years, MS with 8 years, or BS with 12 years of hands-on experience as a study director and/or monitor in toxicology within the pharmaceutical/biotechnology industry or at CROs
• 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
• Demonstrated enthusiasm for scientific research and a commitment to maintaining high-quality standards in toxicology study operations
• Strong critical thinking, analysis, and leadership skills
• Self-motivated to meet performance objectives and to prioritize job-related tasks!
• Ability to adapt to dynamic project needs and