Director, Toxicology

<p>At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.</p><p></p><p>For patients, for each other, and for the future of science, we’re in. Are you?</p><div><div><div><div><div><div><div><p style="text-align:inherit"></p><p style="text-align:left"><b>About the Role:</b></p></div></div></div></div></div></div></div>As a key member of the Nonclinical Safety organization, the Director, Toxicology will play a critical role in bridging global nonclinical strategy with local regulatory execution. Reporting directly to the Global Head of Toxicology and Molecular Mechanisms in Bridgewater, New Jersey, and indirectly to the Head of Regulatory Affairs in Tokyo, you will serve as the primary nonclinical subject matter expert supporting regulatory interactions in Japan.<br>In this strategic leadership role, you will collaborate with global team to shape nonclinical safety strategies, oversee outsourced nonclinical activities, contribute to regulatory submissions of nonclinical data, and engage directly with Japanese regulatory authorities on behalf of the global team.<br>This position is based in Tokyo, Japan.<div><div><div><div><div><div><div><p style="text-align:inherit"></p><p style="text-align:left"><b>What You&#39;ll Do:</b></p></div></div></div></div></div></div></div><ul><li>Serve as the primary nonclinical subject matter expert, partnering closely with global nonclinical colleagues in the U.S. and the local regulatory affairs team in Japan.</li><li>Contribute to the development and implementation of nonclinical safety strategies across programs in the company portfolio and participate in global regulatory interactions as appropriate.</li><li>Author and/or critically review nonclinical sections of regulatory submissions to the Japanese authority (e.g., CTNs, J-NDAs, briefing books for PMDA consultation, responses to PMDA queries) and support preparation for scientific advice meetings (e.g., PMDA consultation, PMDA preliminary meeting, meeting with MHLW for orphan drug designation).</li><li>Represent the nonclinical function in regulatory meetings with Japanese authorities; address inquiries and guide scientific discussions on nonclinical data in collaboration with the global team.</li><li>Oversee and monitor nonclinical activities that are outsourced to contract research organizations in Japan, as appropriate.</li><li>Conduct impurity safety assessments and provide cross-functional guidance to support CMC processes and regulatory filings in Japan.</li><li>Help refine departmental SOPs and best practices to enhance operational efficiency and maintain high-quality standards.</li><li>Maintain up-to-date knowledge of scientific and regulatory developments in safety pharmacology and toxicology.</li></ul><p style="text-align:inherit"></p><p style="text-align:left"><b>Who You Are:</b></p><ul><li><p>Ph.D., DVM, or equivalent degree in Toxicology or a related field; DABT or JCVP certification strongly preferred.</p></li><li><p>At least 15 years of experience as a regulatory toxicologist (e.g., study director/monitor or project toxicologist) in the pharmaceutical or biotechnology industry.</p></li><li><p>Deep understanding of safety pharmacology, drug metabolism and pharmacokinetics, and toxicology.</p></li><li><p>Proven track record of leading toxicology programs through multiple stages of drug development; experience with small molecules, protein biologics, oligonucleotides, and gene therapies is highly desirable.</p></li><li><p>Strong knowledge of GLP regulations and global nonclinical evaluation guidelines, including regional regulatory expectations.</p></li><li><p>Strategic thinker with strong scientific judgment, problem-solving ability, and decision-making skills.</p></li><li><p>Demonstrated leadership skills with the ability to influence and collaborate across functions and geographies.</p></li><li><p>High degree of adaptability and comfort working across multiple time zones.</p></li><li><p>Excellent interpersonal, communication, and presentation skills.</p></li><li><p>Willingness to travel domestically and internationally as needed.</p></li><li><p>Fluency in both English and Japanese is required.</p></li></ul><p><br /><span><b>Life at Insmed</b><br /><br /><span><span>インスメッド日本オフィスは、国会議事堂を望む東京の中心部、溜池山王駅直結の好立地に位置しています。最新のワークスタイルに対応したフリーアドレス制を導入し、開放的で柔軟な働き方を実現しています。カフェエリアでは部門を超えた自由なコミュニケーションやコラボレーションを促進する空間を創り出しています。</span></span><br /><span><span>日本法人の拠点として、患者さんにより良い医療をお届けするため、社員一同が一丸となって日々邁進しています。</span></span><br /><span><span>社員一人一人の充実した働き方を実現するためのサポート&#xff1a;</span></span><br />• ワークライフバランスの実現<br />フレキシブルな勤務時間や充実した休暇制度<br />• 魅力的な報酬制度<br /><span><span>退職金制度、株式報酬制度、従業員持株制度&#xff08;ESPP&#xff09;への参加機会</span></span><br />• キャリア開発支援<br /><span><span>社内研修、外部研修プログラムの活用、LinkedIn</span></span> Learning、業務に特化した専門研修<br />• 先進的な学習支援<br /><span><span>AI搭載の学習ツール、社内リソースへのアクセスを支援するデジタルアシスタント</span></span><br />• <span><span>グローバルの表彰制度や従業員リソースグループ活動</span></span><br />• ハイブリッドワーク環境の整備<br /><span><span>場所や時差を超えたシームレスな協働を実現する最新テクノロジー、充実したIT支援体制</span></span></span></p><p></p><p></p><p></p><p></p><p><i><b>Current Insmed Employees: Please apply via the Jobs Hub in Workday.</b></i></p><p></p><p></p><p></p><p></p><p><i>Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law.<br /><br />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.<br /><br />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 </i><a target="_blank" href="mailto:TotalRewards&#64;insmed.com"><span style="color:#0000ff"><i><u>TotalRewards&#64;insmed.com</u></i></span></a><i>  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.<br /><br />Applications are accepted for 5 calendar days from the date posted or until the position is filled.</i></p>