Associate Director, Clinical Portfolio Technology
Alnylam Pharmaceuticals
9 days ago
Remote friendly (Cambridge, MA)
United States
IT
Associate Director, Clinical Portfolio Technology
Responsibilities
- Drive delivery, adoption, and continuous improvement of technology capabilities supporting clinical trial execution, study oversight, and portfolio decision-making.
- Translate business priorities into technology plans, aligned roadmaps, and measurable outcomes with Clinical Operations, Study Management, Portfolio Management, and DSSE.
- Support delivery, enhancement, and lifecycle management of platforms/capabilities for trial execution, oversight, portfolio analytics, and data-driven decision-making.
- Serve as liaison between Clinical Development and IT to translate business needs, risks, priorities, and trade-offs.
- Coordinate with product owners, vendors, and IT teams for requirements, scope, dependencies, testing, issue resolution, and release readiness.
- Ensure solutions are compliant, validated, and inspection-ready (GxP; 21 CFR Part 11, EU Annex 11; change control, documentation, quality practices).
- Improve processes, data flows, reduce manual effort, and enhance user experience.
- Collaborate with Quality, Security, Architecture, Infrastructure, Integration, Analytics, and application teams to ensure enterprise-aligned solutions.
- Apply learning agility/curiosity, including responsible AI-enabled capabilities.
Qualifications
Required
- Bachelor’s degree in IT, Computer Science, Life Sciences, or related field (advanced degree preferred).
- 8+ years life sciences technology experience, including clinical development platforms in regulated environments.
- Strong understanding of clinical trial processes/systems/operating models; translate operational needs to technology solutions.
- Working knowledge of GxP (21 CFR Part 11, EU Annex 11), validation, change control, inspection readiness.
- Experience with major life sciences technology vendors and cross-functional delivery.
- Strong communication and stakeholder management; hands-on collaboration/problem-solving.
Preferred
- Experience with Medidata, SAS, R/Posit, Veeva Vault, Elluminate, CTMS, EDC, eCOA, eTMF, RBQM, dashboards, portfolio management tools.
- Familiarity with data standards, integrations, analytics/visualization.
- Interest in AI-enabled capabilities for clinical development; Agile/product-oriented delivery and vendor management.
Responsibilities
- Drive delivery, adoption, and continuous improvement of technology capabilities supporting clinical trial execution, study oversight, and portfolio decision-making.
- Translate business priorities into technology plans, aligned roadmaps, and measurable outcomes with Clinical Operations, Study Management, Portfolio Management, and DSSE.
- Support delivery, enhancement, and lifecycle management of platforms/capabilities for trial execution, oversight, portfolio analytics, and data-driven decision-making.
- Serve as liaison between Clinical Development and IT to translate business needs, risks, priorities, and trade-offs.
- Coordinate with product owners, vendors, and IT teams for requirements, scope, dependencies, testing, issue resolution, and release readiness.
- Ensure solutions are compliant, validated, and inspection-ready (GxP; 21 CFR Part 11, EU Annex 11; change control, documentation, quality practices).
- Improve processes, data flows, reduce manual effort, and enhance user experience.
- Collaborate with Quality, Security, Architecture, Infrastructure, Integration, Analytics, and application teams to ensure enterprise-aligned solutions.
- Apply learning agility/curiosity, including responsible AI-enabled capabilities.
Qualifications
Required
- Bachelor’s degree in IT, Computer Science, Life Sciences, or related field (advanced degree preferred).
- 8+ years life sciences technology experience, including clinical development platforms in regulated environments.
- Strong understanding of clinical trial processes/systems/operating models; translate operational needs to technology solutions.
- Working knowledge of GxP (21 CFR Part 11, EU Annex 11), validation, change control, inspection readiness.
- Experience with major life sciences technology vendors and cross-functional delivery.
- Strong communication and stakeholder management; hands-on collaboration/problem-solving.
Preferred
- Experience with Medidata, SAS, R/Posit, Veeva Vault, Elluminate, CTMS, EDC, eCOA, eTMF, RBQM, dashboards, portfolio management tools.
- Familiarity with data standards, integrations, analytics/visualization.
- Interest in AI-enabled capabilities for clinical development; Agile/product-oriented delivery and vendor management.