Director, DSPV Data, Technology and Innovation

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:

What You'll Do:

In this role, you’ll have the opportunity to serve as the designated business owner of Insmed's safety systems, including the safety database, signal and risk management tools, and safety reporting and analytics platforms, accountable for each system from definition of business requirements through implementation, day-to-day use, and eventual retirement.  You’ll also:

Safety Systems Ownership and Vendor Management

• Set and approve business requirements, configuration decisions, user access, and release priorities for safety systems, and make the final business-side decision where trade-offs are required.
• Own the business relationship with safety systems and technology vendors, including performance against agreed service levels, escalation and resolution of issues, product roadmap and release discussions, renewals, and input to contracts and budgets in partnership with IT, Procurement and Legal.
• Hold vendors and contractors accountable for the quality and timeliness of what they deliver and oversee contractors supporting DSPV systems activities.
• Monitor the capacity, performance and stability of safety systems as case volumes and product markets grow and raise risks to DSPV leadership before they affect compliance.  Maintain the DSPV system inventory and the business-side documentation needed to support audits and health authority inspections. 

Technology Strategy, Roadmap and Delivery

• Own the DSPV technology roadmap: what Insmed will build, buy or retire for pharmacovigilance. Review and refresh the roadmap annually with DSPV leadership and IT and secure the funding to deliver it.
• Conduct gap analyses of current PV systems, tools and processes against regulatory requirements, portfolio growth and industry practice, and identify strategies for improvement.
• Lead the evaluation and selection of new safety systems and technologies, including requirements definition, vendor demonstrations, requests for proposal (in collaboration with procurement), and business case development.
• Manage delivery of DSPV technology projects from start to finish, including scope, schedule, budget, resourcing, dependencies, risks and issues, with regular reporting to DSPV and IT leadership.
• Lead business-side activities for safety data migrations, including data mapping, reconciliation, verification of migrated data, and decommissioning of legacy systems.
• Lead the business-side activities that make a new system work in practice, including process design, user acceptance testing, training, cutover and post-implementation support.
• Plan safety system capability ahead of new product launches, label expansions and entry into new markets, so that systems and data are ready before they are needed.

Analytics, Reporting and AI Innovation

• Define what DSPV needs from safety reporting and analytics, including compliance metrics, case processing performance, product-level safety data and management reporting, and meet those needs using platforms Insmed already owns wherever possible.
• Own the design and content of DSPV dashboards and reports, working with IT and the enterprise data platform team to build them, and maintain the definitions behind each metric to ensure harmonization across DSPV.
• Enable signal detection, benefit-risk evaluation and patient exposure analysis by making sure the underlying data, tools and access are in place, working with Global Safety Leads, safety scientists across Medical Safety to understand what those tools need to do.
• Identify, prioritize and manage AI use cases for pharmacovigilance (for example development of conversational interfaces for safety analysis), ensuring the most value adding use cases progress through structured pilots to a clear decision.
• Define success criteria before pilots start, including measurable acceptance criteria, the data required, how performance will be checked over time, and where human review is retained. Present evidence-based recommendations to leadership on whether to scale, adjust or stop.
• Maintain current knowledge of pharmacovigilance technology and of regulatory expectations for AI, including the CIOMS Working Group XIV principles, FDA and EMA guidance on the use of AI in medicines development, and applicable EU AI Act obligations, and share what is relevant with DSPV.
• Where pilot results or new methods are of external interest, publish and present them at industry forums (e.g., DIA, ISOP, ICPE), and maintain a record of what DSPV has evaluated and learned to support future regulatory authority discussions.

Cross-Functional Collaboration and Compliance

• Act as the main point of contact between DSPV and Insmed IT: turn DSPV business needs into requirements and user stories that technical teams can build from, and bring technical constraints, options and costs back to DSPV in terms the function can decide on.
• Support Quality Assurance's validation and change control work with the business inputs it depends on - user requirements, risk assessments, test scripts and evidence, and change impact assessments.
• Partner with the enterprise data platform team on DSPV's use of shared data infrastructure (e.g., Snowflake, Qlik), including data feeds, data quality, access, and reporting standards.
• Partner with the enterprise AI team, which owns Insmed's AI strategy and delivery, to bring DSPV use cases into the enterprise pipeline and to make sure pharmacovigilance requirements are reflected in how AI solutions are built, validated and monitored.
• Work with Regulatory Affairs, Clinical Development, Epidemiology and Biostatistics so that safety systems and safety data support their requirements alongside DSPV's.
• Support health authority inspections and audits on matters relating to safety systems, safety data and technology.
• Contribute to the development and maintenance of DSPV SOPs, work instructions and training materials relating to systems, data and analytics.
• Maintain current knowledge of global PV regulatory requirements affecting systems and data (EMA, FDA, PMDA and other health authorities), including E2B and applicable ICH standards, and make sure Insmed's systems keep pace with them.

Who You Are:

You have a minimum of a Bachelor's degree in a scientific, computational, health-related or information systems discipline required; advanced degree in a related field preferred as well as a minimum of 10 years of experience in a biotech or pharmaceutical company, including at least 7 years working with pharmacovigilance systems, safety data or PV analytics.  

You are or you also have: 

• Demonstrated experience acting as business owner, system owner or business lead for an industry-standard safety database (e.g., Oracle Argus, ArisGlobal LifeSphere/ARISg, Veeva Vault Safety).
• Demonstrated experience implementing safety systems and leading or supporting safety data migrations, including data mapping, reconciliation and legacy system decommissioning.
• Demonstrated project management of technology projects, including scope, schedule, budget, resourcing, and management of risks and issues.
• Demonstrated experience setting technology strategy and leading a multi-year program or portfolio of safety technology initiatives, with budget accountability and the ability to influence senior leaders.
• Experience leading, mentoring or developing teams (direct or matrixed), including external contractors.  Experience managing technology vendors from the business side, including service level performance, escalation, and input to contracts and renewals.
• Experience working with Quality Assurance on computer system validation, user acceptance testing and change control in a regulated GxP environment.
• Working knowledge of MedDRA coding, E2B data standards, and global PV regulatory requirements (ICH E2A-E2F, GVP modules).
• Sufficient understanding of how modern AI and data systems are built and evaluated, including data pipelines, integrations, model evaluation and ongoing performance monitoring, to work effectively with AI engineers, question what is proposed, and set acceptance criteria. The role does not require building models; it does require being able to judge whether one is working.
• Practical experience with AI, machine learning, natural language processing or real-world evidence applications in a pharmacovigilance or clinical development setting strongly preferred.
• Familiarity with enterprise data and business intelligence platforms (e.g., Snowflake, Qlik, Power BI, Tableau) and working knowledge of SQL; familiarity with R, Python or SAS useful but not required.

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:

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.

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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.

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to recruitmentfraud@insmed.com.