Director, Clinical Development

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 four 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.For patients, for each other, and for the future of science, we’re in. Are you?About The RoleThis position is responsible for scientific discussions and deliverables related to clinical data within assigned projects. The role requires close communication and collaboration with global members and Japanese investigators throughout all activities. Responsibilities include the development of study designs, study outlines, study results, and the overall clinical data package. The scope of work covers all stages from early development to post-marketing activities, including company-initiated studies (CIS) and post-marketing surveillance (PMS).The incumbent will lead the design, execution, and completion of clinical studies required to fulfill regulatory submission requirements, prepare submission documents, and aim to obtain marketing authorization. In addition, the role will maintain effective communication with the Pharmaceuticals and Medical Devices Agency (PMDA), including consultation and submission activities, and coordinate discussions related to clinical studies.Furthermore, in collaboration with the Clinical Sub-team, the incumbent will oversee the day-to-day management of clinical trials, ensuring quality, timelines, and compliance are maintained throughout study execution.Although positioned at the Director level, this is a hands-on role that requires the incumbent to actively perform operational and scientific tasks rather than solely delegating work to subordinates.What You'll DoContribute to the strategic development of early- and late-stage clinical programs, providing medical expertise as needed, which may include supporting colleagues in Pharmacovigilance.Provide program-level medical oversight for information included in regulatory documents, such as the clinical sections of CTN submissions and updates (CTN/DSUR), Investigator’s Brochures, IMPD drafts, briefing books, clinical sections of J-NDA/J-CTD submissions, Statistical Analysis Plans (SAP), orphan drug designation applications, and responses to regulatory authority or EC/IRB queries. Provide medical and scientific input by working closely with Clinical Scientists and Clinical Operations throughout all phases of clinical studies—before, during, and after conduct—and identify or resolve issues related to study design. Plan and execute clinical studies in Japan.Participate in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics submissions, and recruitment materials. Collaborate with internal teams and CROs to prepare and finalize clinical study protocols and related amendments, ensuring compliance with Clinical Development Plans and regulatory requirements. Review key study documents, including informed consent forms, study guidelines, operations manuals, and training materials. Participate in investigator meetings, study kick-off meetings, monitoring training sessions, and meetings with CROs or other vendors. Stay current with scientific and medical advances in relevant therapeutic areas, and proactively develop and maintain relationships with external experts; represent the company in professional forums as needed. Contribute to process improvements, including the creation, revision, and maintenance of SOPs.Collaborate effectively with cross-functional partners—such as Regulatory Affairs, Project Management, Clinical Operations, Medical Affairs, Drug Safety/Pharmacovigilance, Medical Information, and Clinical QA—to ensure project progress and success.Experience/KnowledgeWho You Are:Minimum of 10 years of experience in clinical development or related functions within the pharmaceutical, biotechnology, regulatory authority (e.g., PMDA), or academic research organization setting, including experience in leading clinical programs and regulatory submissions (e.g., J-NDA). For candidates with an M.D. degree, relevant clinical practice experience may be considered as part of the total required experience.Demonstrated experience working in a global, cross-functional team environment.Experience in respiratory (including pulmonary hypertension and interstitial lung disease, and bronchiectasis), infectious disease, immunology, otolaryngology (ENT; including sinusitis), dermatology, neurology, and/or gene therapy therapeutic areas is preferred.Experience in managing development programs and participating in J-NDA submissions is preferred.Basic understanding of the gene therapy field.Strong working knowledge of Good Clinical Practice (GCP), scientific and clinical methodology, protocol design, project management, and regulatory requirements for clinical studies.Skills/CapabilitiesLanguage proficiency:Native-level fluency in Japanese (reading, writing, and conversation) is required.High-level business fluency in English is required.Uncompromising ethical standards and professional integrity are essential.Highly organized, with strong attention to detail, clarity, accuracy, and conciseness.Proven ability to work both independently and collaboratively in cross-functional teams; demonstrates strong time management skills, can perform effectively under pressure, and contributes as a proactive team player.Demonstrated influence, negotiation, and conflict resolution skills, including the ability to influence effectively with appropriate support from leadership.Strong problem-solving mindset with the ability to develop creative and practical solutions.Excellent verbal and written communication and presentation skills (in both Japanese and English), with the ability to clearly convey ideas and influence others to achieve desired outcomes.Demonstrated experience in improving, developing, and implementing new processes.Flexible, diplomatic, and capable of working effectively in situations of ambiguity.Highly proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).Qualification/CertificateMaster’s degree in Life Sciences, Pharmaceutical Sciences, or a related discipline is required.A doctoral degree (Ph.D. or M.D.) is preferred.OthersMust consistently demonstrate Insmed’s five (5) core corporate competencies: Collaboration, Accountability, Passion, Respect, and Integrity, along with any other role-specific competencies.Must demonstrate the ability to interact effectively and collaboratively in a dynamic and culturally diverse environment.Non-smoker.Willingness and ability to travel approximately 20–30% (domestic and international), including overnight travel as required.Life at Insmed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。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。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： ワークライフバランスの実現フレキシブルな勤務時間や充実した休暇制度 魅力的な報酬制度退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会 キャリア開発支援社内研修、外部研修プログラムの活用、LinkedIn Learning、業務に特化した専門研修 先進的な学習支援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 グローバルの表彰制度や従業員リソースグループ活動 ハイブリッドワーク環境の整備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, 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.