Director, Toxicology Project Lead

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

As a key member of the Nonclinical Safety team, the Director, Toxicology Project Lead, reports directly to the Head of Toxicology and Molecular Mechanisms. In this strategic leadership position, you will serve as the primary toxicology representative on cross-functional project teams, leading the development and execution of nonclinical safety strategies. You will oversee safety pharmacology and toxicology studies in collaboration with study monitors, contribute to regulatory submissions, and play a crucial role in shaping our development pipeline by addressing regulatory inquiries and influencing program direction. This position is based at our headquarters in Bridgewater, New Jersey, with the flexibility to accommodate remote candidates from across the United States.

Responsibilities

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

• Act as the primary toxicology representative on project teams, collaborating closely with discovery, bioanalysis, pharmacokinetics, clinical development, manufacturing, and program management to shape and drive project strategy and timelines.
• Lead the formulation and execution of comprehensive nonclinical safety strategies from discovery through to market application, ensuring alignment with regulatory guidelines and corporate objectives.
• Provide scientific direction on the design, execution, and interpretation of safety pharmacology and toxicology studies, ensuring high-quality, reliable data generation.
• Author and review nonclinical sections of regulatory submissions (e.g., IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, annual reports, briefing documents) and contribute to scientific advice preparation.
• Represent toxicology in meetings with global regulatory authorities, addressing inquiries and guiding discussions on nonclinical safety data.
• Lead issue-resolution initiatives, offering scientific expertise and strategic recommendations to address safety concerns.
• If appropriate, serve as peer review pathologist to toxicology studies conducted at CROs.
• Conduct impurity safety assessments, providing guidance to support setting specification limits in manufacturing processes and regulatory submissions.
• Contribute to improving departmental SOPs and standard methodology documents, improving operational efficiency and upholding high-quality standards.
• Maintain the state-of-art scientific and regulatory advancement in safety pharmacology and toxicology.

About You:

• Ph.D., DVM, or equivalent in Toxicology, Veterinary Pathology or a related discipline; DABT/DACVP/ERT or equivalent certification is strongly preferred.
• Minimum of 10 years as a regulatory toxicologist (study director/monitor and project lead) or pathologist in the pharmaceutical or biotechnology industry.
• Demonstrated success in leading toxicology programs through various stages of drug development, with experience in biologics, oligonucleotides, and/or gene therapies being highly advantageous.
• Advanced knowledge of safety pharmacology, drug metabolism and pharmacokinetics, toxicology, and pathology.
• Thorough understanding of GLP regulations and nonclinical evaluation guidelines across different regulatory landscapes.
• Strategic and critical thinking with robust scientific acumen and proven problem-solving skills.
• Strong leadership capabilities with the ability to effectively influence cross-functional teams and collaborators.
• High adaptability to changing project requirements and the ability to manage work across various time zones.
• Excellent interpersonal, communication, and presentation skills, with a strong collaborative approach!
• Willingness to travel on business (up to 15%) both domestically and internationally.

Salary Range

171000-239667

Compensation & Benefits

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus 
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

 

For more information on U.S. benefits click here.

 

 

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.