Insmed Incorporated

In this role, you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries.. Act as the primary representative for toxicology at cross-functional project teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall development strategy and timeline of candidate molecules.. DVM, Ph. D., or equivalent in Toxicology or a related discipline.. Minimum of 15 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a regulatory authority.. Advanced knowledge of toxicology, pharmacology, safety pharmacology & DMPK.

senior director

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
Named Science's Top Employer in 2021, 2022, and 2023
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 were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.
A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, and Best Workplaces for Millennials lists.
Overview
Overview The Director, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and Molecular Mechanisms. In this role, you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries. This position is located at our headquarters facility in Bridgewater, New Jersey.
Responsibilities
ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited to, the following:
<ul>
<li>Act as the primary representative for toxicology at cross-functional project teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall development strategy and timeline of candidate molecules.</li>
<li>Provide strategic direction on toxicology from discovery throughout market application for programs in different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.</li>
<li>Provide scientific guidance on study design, execution, and interpretation of nonclinical safety data; and oversee nonclinical safety studies outsourced to contract research organizations.</li>
<li>Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on Program and Clinical/Regulatory strategy.</li>
<li>Author nonclinical sections in regulatory submission documents (e.g., IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, Scientific Advice, annual reports, and briefing documents).</li>
<li>Contribute to issue-resolution teams, driving the scientific approach for toxicology issue resolution.</li>
<li>Provide impurity safety assessment in support of CMC manufacturing and/or registration.</li>
<li>Contribute to department SOPs and best practice documents.</li>
</ul>
Qualifications
<ul>
<li>DVM, Ph.D., or equivalent in Toxicology or a related discipline. DABT/DACVP certification preferred.</li>
<li>Minimum of 15 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a regulatory authority.</li>
<li>Proven track record of successfully leading toxicology programs through various stages of drug development.</li>
<li>Experience in toxicology on biologics, oligonucleotides, and/or gene therapies is a plus.</li>
<li>Advanced knowledge of toxicology, pharmacology, safety pharmacology & DMPK.</li>
<li>Comprehensive knowledge of GLP regulations and all regulatory guidance related to the nonclinical evaluation.</li>
<li>Passion for science with strong strategic thinking, critical thinking, and leadership skills.</li>
<li>Agility to adapt to changes and flexibility to work across different time zones.</li>
<li>Excellent interpersonal and communication skills.</li>
</ul>
Travel Requirements
Upto 5% travel
Salary Range
Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $170,000.00 to $236,667.00 per 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:
<ul>
<li>Flexible approach to where and how we work, regionally based</li>
<li>Competitive compensation package including bonus</li>
<li>Stock options and RSU awards</li>
<li>Employee Stock Purchase Plan (ESPP)</li>
<li>Flexible Vacation Policy</li>
<li>Generous paid holiday schedule and winter break</li>
</ul>
ADDITIONAL U.S. BENEFITS:
<ul>
<li>401(k) plan with company match</li>
<li>Medical, dental, and vision plans</li>
<li>Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance</li>
<li>Company-provided short and long-term disability benefits</li>
<li>Unique offerings of pet, legal, and supplemental life insurance</li>
<li>Flexible spending accounts for medical and dependent care</li>
<li>Accident and Hospital Indemnity insurance</li>
<li>Employee Assistance Program (EAP)</li>
<li>Mental Health on-line digital resource</li>
<li>Well-being reimbursement</li>
<li>Paid leave benefits for new parents</li>
<li>Paid time off to volunteer</li>
<li>On-site, no-cost fitness center at our U.S. headquarters</li>
</ul>
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.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.

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