Director Toxicology - Bridgewater, United States - Insmed Incorporated

Insmed Incorporated Bridgewater, United States

2 weeks ago

Full time

Description

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 BiopharmaTM, Best Workplaces in New YorkTM, and Best Workplaces for MillennialsTM lists.

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

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

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.

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.

Provide scientific guidance on study design, execution, and interpretation of nonclinical safety data; and oversee nonclinical safety studies outsourced to contract research organizations.

Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on Program and Clinical/Regulatory strategy.

Author nonclinical sections in regulatory submission documents (e.g., IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, Scientific Advice, annual reports, and briefing documents).

Contribute to issue-resolution teams, driving the scientific approach for toxicology issue resolution.

Provide impurity safety assessment in support of CMC manufacturing and/or registration.

Contribute to department SOPs and best practice documents.Qualifications

DVM, Ph.D., or equivalent in Toxicology or a related discipline. DABT/DACVP certification preferred.

Minimum of 10 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.

Proven track record of successfully leading toxicology programs through various stages of drug development.

Experience in toxicology on biologics, oligonucleotides, and/or gene therapies is a plus.

Advanced knowledge of toxicology, pharmacology, safety pharmacology & DMPK.

Comprehensive knowledge of GLP regulations and all regulatory guidance related to the nonclinical evaluation.

Passion for science with strong strategic thinking, critical thinking, and leadership skills.

Agility to adapt to changes and flexibility to work across different time zones.

Excellent interpersonal and communication skills.

Qualifications