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 ​Key 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 the enhancement of departmental SOPs and best practice documents, driving operational efficiency and maintaining 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 beiTo view the full job description, click here