Associate 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 an Associate Director, Clinical Trial Operation on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Clinical Operations – Gene Therapy, you’ll be responsible for the overall leadership, management, and oversight of phase I-IV clinical trials from protocol concept through Clinical Study Report (CSR) to ensure all study(s) are delivered on time, within budget, and with high quality data. You will also lead the cross- functional Clinical Study Team (CST), CTMs, CTAs, the Contract Research Organization (CRO) and other vendors (as applicable) to ensure execution of all operational aspects of clinical study(s) planning, implementation, data delivery and reporting. You will also drive the adoption and integration of digital health and eClinical technologies to enhance data quality, operational efficiency, and real-time trial oversight, as well as champion patient-centric trial design as a core leadership expectation, ensuring that study execution strategies prioritize patient experience, accessibility, and engagement throughout the clinical development lifecycle.

What You'll Do:

In this role, you’ll have the opportunity to provide leadership and management of a clinical study(s) and clinical operations aspects of a drug development program in compliance with ICH GCP guidelines and relevant regulatory guidelines. You’ll also:

• Establish and lead the clinical study team and CST meetings throughout the trial – overseeing team member maintenance of trial-specific training and facilitating continuity during team member transitions
• Manage and oversee the operational aspects of Insmed’s clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, clinical trial sites, etc
• Review metrics and Key Performance Indicators to identify trends and trigger proactive risk management activities where applicable and ensure oversight of clinical trial progress
• Oversee the day to day of clinical trial execution
• Create and/or review and approve specific study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, study plans
• Apply Risk-Based Quality Management (RBQM) principles to ensure data integrity and patient safety
• Lead vendor (including CRO) selection process in collaboration with vendor alliance and procurement colleagues (as applicable) and other key internal stakeholders and provide input to the request for proposal process (if applicable) contract/work order reviews, and maintenance through trial closeout
• Oversee vendors' adherence to contractual obligations including proactively recognizing changes in scope (eg cost, timelines)
• Cross-check quality and completeness of study documents and reconciliation with eTMF colleagues and other functional areas throughout the trial lifecycle
• Provides mentorship to assigned study staff (CTMs, and CTAs) or colleagues as assigned by the Senior Director

Who You Are:

You have a Bachelor’s degree in the life sciences, healthcare, or related field, and 7+ years in trial management with a sponsor company managing various phase clinical trials.   

You are or you also have:

• Experience in global clinical trial conduct in multiple phases of development across several therapeutic areas
• Experience in financial management of clinical trials, including budgeting, forecasting, accruals, invoicing, etc.
• Experience in CRO, vendor and laboratory selection, set-up, and management
• Must have excellent communication skills (verbal and written)
• Possess critical thinking skills for problem solving, conflict resolution, collaboration, interpretation and in leadership tasks
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness
• Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies

 

Nice to Have (but not required):

• Experience in rare disease and/or orphan indications is preferred
• Experience in the management acrosse a development program and participation in NDA/sNDA filing is preferred

 

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 will be expected.

 

Travel Requirements

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

 

#LI-Remote

#LI-JK

Pay Range:

$164,000.00-213,000.00 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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

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.