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 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.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role:

Responsible 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 Do:

• Leads 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 Are:

Position 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 skills

• Experience 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 manager

• Possess critical thinking skills for problem-solving, conflict resolution, collaboration, and interpretation. Excellent 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 competencies

Where You'll Work

This role is based out of our Tokyo office with weekly flexibility to support both your professional and personal needs.

Travel Requirements

This role requires occasional domestic/international travel (approximately 25%)

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Current Insmed Employees: Please apply via the Jobs Hub in Workday.

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.

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.