Senior Associate, Clinical Trial Operations - Gene Therapy

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:

We’re looking for a Senior Associate, Clinical Trial Operations on the Clinical Operations - Gene Therapy Team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Clinical Operations - Gene Therapy, you’ll assist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.

What You'll Do:

In this role, you’ll have the opportunity to work with global cross‐functional teams to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, project plans, ICH/GCP guidelines, government regulations, etc.

You’ll also:

• Support Clinical Operations through study start-up, patient recruitment, maintenance, and study closure activities.

• Coordinate the creation and distribution of study materials, including essential documents, presentations, and reports.

• Lead site and sponsor training tracking, maintain training matrices, and assign study-specific plans via Insmed's Learning Management System (LMS).

• Track essential study milestones and maintain study trackers (e.g., team roster) to support study oversight.

• Facilitate logistics for Investigator Meetings held by third-party vendors in collaboration with Insmed.

• Serve as the point of contact and liaison for the Medical Review Committee (MRC) on site/patient-facing materials.

• Drive clinical study team and vendor meetings by scheduling, drafting agendas, capturing action items, and documenting decisions.

• Review and submit CRO/vendor contractual documents, work orders, change orders, and amendments into Procurement and legal approval systems.

• Assess CRO/Vendor SOPs for applicability and gap analysis to support Insmed clinical trials.

• Partner with Quality Assurance to support audits, inspections, and regulatory body inspection readiness, including document retrieval and CTA inspection readiness checks from startup through closeout.

• Process clinical trial invoices and liaise with Finance to create purchase orders and requisitions via the Procurement system.

• Mentor and train CTAs as appropriate.

• Maintain the Trial Master File (TMF), lead periodic TMF QC checks, and oversee Sponsor- and CRO-supported TMF quality activities per ICH/GCP requirements.

• Report TMF metrics, identify risks and trends, and follow up with CROs and functional area representatives on outstanding issues.

• Conduct monitoring, co-monitoring, and oversight monitoring activities to support ongoing clinical trial oversight.

Who You Are:

You have a minimum Bachelor's degree in healthcare, life sciences or a related field along with 3+ years of progressive experience in a Clinical Operations role on the sponsor side or 5+ years at a CRO.

You are or you have:​

• Demonstrated hands-on monitoring experience along with a solid understanding of clinical research processes, including all functional areas of clinical trials, medical terminology, and FDA/local regulatory requirements.

• Ability to apply proven knowledge of budgetary and financial practices, including budget review and forecasting, purchase order management, and payment tracking for external parties.

• Extensive experience with Trial Master Files (TMF), both paper and electronic (eTMF), including Veeva, with a strong understanding of the DIA TMF Reference Model.

• Experience executing study start-up activities with confidence, including feasibility assessments, country and site activation, and patient recruitment efforts.

• Able to collaborate effectively with CROs and third-party vendors to ensure quality study execution and build strong, productive team alliances.

• Ability to coordinate seamlessly with global cross-functional team members to plan and execute study activities across all regions.

• Ability to communicate clearly and effectively — both verbally and in writing — while demonstrating strong conflict management skills and a high level of organization, attention to detail, and accuracy.

Nice to have (but not required):

• Experience in rare disease and/or orphan indications is preferred.

• Demonstrated ability to train and mentor/ new hires and colleagues, as needed.

Where You’ll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.

Travel Requirements

This role requires occasional [domestic/international/global] travel (approximately 25%).

Pay Range:

$113,000.00-143,500.00 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. 

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

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

 

• A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or

• An alternative selection process by emailing Privacy@insmed.com.

• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.