Head of Clinical Data Management at Insmed Incorporated

, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Sep, 26

Salary

347500.0

Posted On

06 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Strategic Leadership, Vendor Oversight, CDISC Standards, EDC Systems, Regulatory Submissions, GxP Compliance, Data Integration, Risk-based Data Review, Resource Planning, Change Management, Cross-functional Collaboration, Automation, AI-enabled Workflows, Inspection Readiness, Clinical Trial Lifecycle

Industry

Biotechnology Research

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 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 Head of Clinical Data Management to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Biometrics, the Head of Clinical Data Management will serve as a strategic and operational leader responsible for overseeing all aspects of Clinical Data Management across the development portfolio, from early development through regulatory submissions and post-marketing activities. This role is accountable for the strategy, quality, consistency, and delivery of all data management activities, while advancing modern data capabilities, operational excellence, technology innovation, and scalable processes to support efficient and high-quality drug development. The ideal candidate combines deep operational expertise in clinical data management with a forward-looking mindset in technology, automation, data integration, and innovation. This role partners closely with Biometrics, cross-functional stakeholders, and external partners to ensure timely, high-quality, inspection-ready clinical data across the portfolio. What You'll Do: In this role, you’ll have the opportunity to define and execute the strategy for Clinical Data Management support across studies, programs, and evidence generation activities, in close collaboration with Biometrics leadership and key cross-functional stakeholders. You’ll also: Be accountable for the quality, consistency, and strategic delivery of all data management activities across the portfolio, including CRF/eCRF design, database build and validation, edit check specifications, data review and cleaning, external data integrations and reconciliations, medical coding, query management, database lock activities, and submission readiness. Build, develop, and lead a high-performing Data Management organization with strong operational expertise and leadership bench strength; set priorities, conduct performance evaluations, drive talent development, and oversee resource planning and allocation. Establish and maintain robust quality control and risk mitigation frameworks; ensure compliance with industry standards, global regulatory requirements, and internal SOPs; maintain inspection readiness and support regulatory interactions and audits. Provide strategic leadership for data management systems, technologies, automation, and innovation initiatives to build scalable, compliant, and future-ready data capabilities within a validated GxP environment. Lead strategic departmental initiatives to strengthen operational excellence, standardization, inspection readiness, and continuous improvement across the Data Management organization. Lead modernization initiatives across data management processes and capabilities, including areas such as data integration and reconciliation, centralized and risk-based data review, automation, AI-enabled workflows, metadata-driven processes, and data interoperability. Partner closely with Programming, Biostatistics, IT, and Digital teams to advance integrated data and analytics ecosystems. Foster strong collaboration within Biometrics and across functions; represent Data Management in key cross-functional forums and enterprise initiatives. Who You Are: You must have a Master’s degree or PhD in Life Sciences, Computer Science, Data Science, Statistics, or a related discipline and 12+ years of progressive experience in Clinical Data Management within the pharmaceutical or biotechnology industry. Additionally, you have: 8+ years of leadership experience managing teams, functions, and complex development portfolios. Deep understanding of the clinical trial data lifecycle, clinical data management processes, GCP and global regulatory requirements, CDISC standards, EDC systems, external data integrations, database lock processes, and inspection readiness expectations. Demonstrated experience leading Data Management activities for Phase 2 and Phase 3 global clinical trials, including support for regulatory submissions (NDA/BLA/MAA/PMDA and global filings) and health authority inspections. Proven experience with modern clinical data technologies, automation, digital transformation, and innovation initiatives, including building or modernizing data management capabilities, processes, and infrastructure within a validated GxP environment. Strong experience with vendor oversight, outsourcing models, and global CRO partnerships. Demonstrated ability to build high-performing teams and maintain high standards of quality, accountability, and operational excellence. Strong strategic thinking, operational execution capabilities, and cross-functional leadership and influence. Excellent communication, leadership, problem-solving, and organizational change management skills. Nice to have (but not required): Experience in rare disease, respiratory, immunology, gene therapy, or specialty biotech development programs 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 position involves occasional domestic and/or international travel (approximately 10%). #LI-MM1 #LI-Remote Pay Range: $255,000.00-347,500.00 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. Insmed is a people-first global biopharmaceutical company driven to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, NJ, with locations across the U.S., EMEA, and Japan, we’re guided by our core values and a shared commitment to patients and each other. We’ve been named Science’s No. 1 Top Employer four years in a row, certified as a Great Place to Work in the U.S., and recognized among The Sunday Times’ and BioSpace’s Best Places to Work. For patients, each other, and the future of science, we’re in. Are you? Wherever you are in the world or in your career, we want to stay connected. Sign up for our talent community to hear about new career opportunities, company news, and how our teams around the world are striving to make a difference for patients every day. Sign UP

Responsibilities

Lead the strategic and operational oversight of Clinical Data Management across the development portfolio from early stages through regulatory submissions. Drive modernization initiatives including AI-enabled workflows and automation to ensure high-quality, inspection-ready clinical data.