Associate Director, Toxicology Study Monitor

Insmed • Bridgewater, NJ

365d • $151,000 - $212,067

About The Position

The Associate Director, Toxicology Study Monitor, is a pivotal member of the Nonclinical Safety team, reporting directly to the Head of Toxicology and Molecular Mechanisms. You will 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). 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 based at our headquarters in Bridgewater, New Jersey, with the flexibility to accommodate remote candidates from across the United States.

Requirements

• Ph.D. with a minimum of 7 years, M.S. with 12 years, or B.S. with 15 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, safety pharmacology, and drug metabolism and pharmacokinetics 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 strategic thinking, critical analysis, and leadership capabilities.
• Ability to adapt to dynamic project needs and manage studies across different time zones.
• Excellent interpersonal, communication, and negotiation skills, with a strong collaborative mindset.
• Willingness to travel (up to 20%) on business both domestically and internationally.

Responsibilities

• Collaborate with toxicology project leads and subject matter experts in discovery, bioanalysis, pharmacokinetics, and manufacturing 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, timelines, 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.
• Stay updated with the state-of-art scientific and regulatory knowledge that are critical for the conduct of safety pharmacology and toxicology studies.

Benefits

• Flexible approach to where and how we work, regionally based
• Competitive compensation package including bonus
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break
• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees