Senior Clinical Trial Manager

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 RoleResponsible for the management and oversight of global phase I-IV clinical trials, with a key focus on Ph2b-3, from start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services, management of project timelines and deliverables. Key global trial management support to the Associate Directors (CST Leads), as assigned.What You'll DoLeads and coordinates the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.Detailed management and oversight of regional trial activities, as assigned.Effectively manages third-party suppliers to contracted deliverables within quality, cost, and timeline parameters.Effectively manages and/or assists with cross-functional clinical study team members to achieve deliverables with high quality, on time, and within budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning.Monitors study metrics to ensure quality and performance standards are met by vendors and assigned program staff.Develops and manages detailed project and other trial-related plans and documentation and provides regular study status updates to senior management.Manages vendors' adherence to contractual obligations including proactively recognizing changes in scope and collaborating with senior management to ensure timely completion of contractual documents, including change orders.Provides coaching/mentoring to assigned program staff (CRAs, and CTAs) by demonstrating leadership competencies.Works collaboratively with Clinical Scientist, Clinical Indication/Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings. Proactively identifies potential resource needs to management. Participates in the development and review of department SOPs and process improvement initiatives.Who You ArePosition Requirements (Required and/or Preferred Skills, Experience and Education):Bachelor's degree in the life sciences, healthcare, or related field.Minimum of 7+ years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial execution.Minimum 2+ years of indirect/influence management of team members, including coaching and mentoring for knowledge sharing and enhanced communication and leadership skillsExperience in rare disease and/or orphan indications is preferred.Experience managing global, large and/or complex studies and project teams is required. Experience in rare disease and/or orphan indications is preferred.Demonstrated experience managing global CROs and other specialty vendors is essential.Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations.Demonstrated strong leadership skills and the ability to work successfully in matrixed team environment.Can work independently with minimal oversight and proactively initiates before asked to assist colleagues and/or managerPossess critical thinking skills for problem-solving, conflict resolution, collaboration, and interpretationExcellent written and oral communication skills, as well as conflict management, time management and organizational skills.Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competenciesTravel: Up to 25% travel, domestic and international 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.