Senior Manager, Bio-Sample 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 Manager, Bio-Sample Operations. As a member of the Clinical Business Operations team within Development Operations you will serve as the operational lead for clinical sample integrity, managing the full lifecycle from collection to disposition. This role provides strategic day-to-day oversight of central and specialty laboratories, ensuring compliance with study protocol and Informed Consent Forms (ICFs) requirements for safety and biomarker samples across a portfolio of studies.

What You'll Do:

In this role, you’ll have the opportunity to oversee vendor selection, management, and performance for central safety (and specialty) laboratories ensuring high-quality, on-time delivery.

You’ll also:

• Provide technical and operational leadership for clinical study teams regarding laboratory oversight and bio-sample operations.
• Manage directly and/or through oversight of vendors/contractor(s), the end-to-end lifecycle of bio-samples, including collection, logistics, processing, analysis, data cleaning, and final disposition.
• Review of critical study documents, including Informed Consent Forms (ICFs), study protocols and CRO Clinical Laboratory Specifications (CLS) ensuring feasibility and alignment of sample collection procedures.
• Responsible for acting as the Translational Bioanalytical Science (TBAS) group's central point of contact for operational issues, proactively addressing potential quality issues with biomarker sample processing and/or shipment.
• Partner with cross-functional teams (Clinical Trial Operations, Clinical Development, Bioanalytical Sciences) to resolve sample-related informed consent and ethical queries. 
• Oversee end-to-end clinical sample logistics, including the management, distribution, and tracking of lab kits and supplies to sites, coordinating with internal teams and external vendors.
• Oversee chain-of-custody and sample accountability from collection through analysis and long-term storage to ensure compliance with GxP and ICH/GCP guidelines. 
• Provide direct support to investigational sites, including training on lab procedures, troubleshooting issues, and rapid escalation resolution.
• Resolve bio-sample data reconciliation issues by collaborating with Data Management and CRO partners.
• Contribute to CRF development to ensure accurate laboratory sample data collection, tracking, and reconciliation.

Who You Are:

You have a Bachelor’s degree along with a minimum of 6 years’ experience working in clinical research setting with a Sponsor/CRO company required.

You are or you also have:

• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials is required.
• Experience in clinical trial conduct in multiple phases of development across several therapeutic areas preferred.
• Strong leadership and project management skills, demonstrated flexibility and agility working within a multi-functional, global matrix
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Roll-up-your-sleeves orientation and a strong ability to work in a team-based environment 
• 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 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

Minimal travel expected

Pay Range:

$133,000.00-173,000.00 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.