Associate Director, Toxicology Study Monitor
Insmed Incorporated

Job Info

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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 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.

Responsibilities

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

• 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.

About You:

• 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.

Travel Requirements

20% domestically and internationally

Salary Range

$151,000 - $212,067 a year

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• 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

ADDITIONAL U.S. BENEFITS:

• 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

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. 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.

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 TotalRewards@insmed.com 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.

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