Senior Director, Clinical Trial Operations

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 Director, Clinical Trial Operations on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Vice President, Development Operations, you’ll provide strategic leadership and operational oversight for clinical trials across Insmed's development pipeline. This role is responsible for ensuring the successful planning and execution of clinical studies from protocol development through study closeout, while maintaining the highest standards of quality, compliance, and patient safety.

This is a remote position.

What You'll Do:

In this role, you’ll have the opportunity to develop and implement clinical operations strategies, aligned with corporate objectives and Program goals.

. You’ll also:

• Provide functional subject matter expertise to the Global Program Team and develop clinical trial scenarios, options, timeline, and budget projections for decision-making.

• Leverage broad clinical trial industry and biotech leadership experience to think beyond the clinical operations function and contribute to setting strategy for the Program, as requested.

• Foster collaborative relationships with key external stakeholders, including clinical trial Investigators, Research Coordinators and Suppliers; Cultivate important relationships with key internal stakeholders, including Insmed senior management and cross-functional leadership.

• Potentially serve on the Global Development Operations Leadership Team and contribute to setting Department strategy.

• Ensure high-quality, consistent planning and execution of Phase I-IV clinical trials, including oversight of study feasibility, site selection, trial recruitment, data monitoring, study closeout, TMF, and study risk management.

• Ensure compliance with GCP, FDA, EMA, and other regulatory requirements.    

• Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, and other departments on the Global Clinical Team, responsible for delivery of trials within a Clinical Development Plan.

• Partner with Procurement and Vendor Alliance Management to optimize external supplier performance, including establishing performance metrics, risk-sharing agreements, and partnership governance.

• Benchmark, track, report, and evaluate operational and trial metrics, with the ability to interpret complex issues and communicate program status in a concise fashion to an executive audience.

• Identify opportunities to improve the efficiency and/or effectiveness of clinical trial operations, develop strategies, make recommendations, and lead process improvement/enhancement initiatives.

• Lead, coach, and develop a high-performing team of clinical operations professionals.

• Manage resource allocation and capacity planning across multiple studies.

• Foster a culture of quality, accountability, and patient-centricity.

Who You Are:

You have a Bachelors degree in life sciences, healthcare or a related field

along with 12+ years of progressive clinical research/operations experience in the pharmaceutical/biotech industry and 5+ years in senior leadership roles managing clinical operations teams.

You are or you also have:

• Extensive experience across all phases of clinical research and across multiple therapeutic areas.

• Robust knowledge of GCP, FDA regulations, and international regulatory requirements.

• Proven track record of successful study execution and delivery in a fast-paced, dynamic environment.

• Strong vendor management skills and CRO oversight experience.  

• Previous CRA/monitoring experience.

• Experience in rare disease or respiratory therapeutic areas.

• Experience with adaptive trial designs and innovative clinical trial methodologies.

• Experience with regulatory submissions and Heath Authority inspections.

Up to 25% domestic and international travel may be required for site visits, supplier meetings, and cross-functional/team collaboration.

#LI-TB1

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Pay Range:

$222,000.00-303,000.00 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.