Director, DSPV Data, Technology and Innovation

About the Role

The Director, DSPV Data, Technology and Innovation is the business owner of Insmed's safety systems and is accountable for the DSPV data, technology and innovation strategy and roadmap, and for its delivery. You will decide, on behalf of Drug Safety & Pharmacovigilance, what technology DSPV needs, in what order it will be delivered, and whether what is delivered is fit for purpose. You will represent DSPV in enterprise technology, data and AI governance forums and work closely with Insmed's IT function, the enterprise data platform team, Quality Assurance and the enterprise AI team.

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, 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.

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 and safety scientists across Medical Safety.
• Identify, prioritize and manage AI use cases for pharmacovigilance, 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.
• 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.
• Where pilot results or new methods are of external interest, publish and present them at industry forums (e.g., DIA, ISOP, ICPE).

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.
• 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 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.

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.

• 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.
• 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.