Description

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 Role:
The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV clinical trials, with a key focus on Phase 1-2a, 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, monitoring oversight of site-level activities related to ongoing and planned trials, management of third-party vendors for clinical services, management of project timelines and deliverables. Key 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 and 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.
• Manages global monitoring oversight of site-level activities related to ongoing and planned trials
• 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.

Qualifications:

• Bachelor's degree in the life sciences, healthcare, or related field.
• Minimum of 5+ years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial execution.
• Experience in rare disease and/or orphan indications is preferred.
• Experience managing large and/or complex studies and project teams is preferred. Experience in rare disease and/or orphan indications is preferred.
• Demonstrated experience managing 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 limited 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.
• Up to 25% travel, domestic and international required.

Who You Are:

Pay Range:
$119,000.00-167,267.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.