Vice President, Pipeline Delivery Systems & Process Enablement
Alnylam Pharmaceuticals
4 hours ago
Remote friendly (Cambridge, MA)
United States
$301,800 - $408,200 USD yearly
Operations
Key Responsibilities
- Define and execute the Pipeline Delivery systems and data strategy aligned to R&D priorities and the future-state operating model, including oversight of integrated clinical and operational platforms.
- Partner with IT and Digital to deliver scalable, user-centric solutions and a single source of truth.
- Design, implement, and continuously improve end-to-end processes across study start-up, execution, data flow, and reporting to meet regulatory requirements and inspection readiness.
- Standardize workflows, templates, and best practices; eliminate redundant or low-value processes.
- Partner with Portfolio Management to establish a performance management framework (KPIs, metrics, dashboards).
- Identify and address operational bottlenecks, inefficiencies, and variability.
- Lead continuous improvement initiatives to enhance cycle times, data quality, and execution predictability; embed operational discipline and continuous learning.
- Develop and implement a comprehensive training strategy aligned to systems, processes, and ways of working; ensure role-based training and build data literacy and adherence.
- Lead enterprise change management to drive adoption of new systems/processes/operating models; manage stakeholder engagement, communication, and behavior change.
- Serve as a key integrator across Clinical Operations, Data Management, Program Management, and R&D; ensure aligned handoffs, ownership, and execution; align with Vendor & Alliance Management.
- Build and lead a high-performing Systems & Process Enablement organization; define roles/capabilities/structure; develop talent and succession planning.
Qualifications
- BS/MS in Life Sciences, Engineering, Information Systems, Business, or related field.
- 20+ years’ biotech/pharma experience with leadership in clinical systems, operations, process excellence, or digital enablement.
- Enterprise/portfolio experience supporting complex, multi-program clinical pipelines.
- Track record implementing enterprise systems and process transformations in R&D/Clinical Development (e.g., CTMS, eTMF, data platforms, reporting/analytics).
- Experience driving large-scale change management and adoption initiatives.
- Experience partnering with IT, Digital, and Data organizations to deliver scalable, user-centric solutions.
- Expertise establishing performance management frameworks (KPIs, dashboards, operational metrics).
- Strong continuous improvement mindset.
- Strong understanding of clinical development processes, data flows, and regulatory requirements.
- Strong organizational change management capability (stakeholder engagement, communication planning, adoption measurement).
- Define and execute the Pipeline Delivery systems and data strategy aligned to R&D priorities and the future-state operating model, including oversight of integrated clinical and operational platforms.
- Partner with IT and Digital to deliver scalable, user-centric solutions and a single source of truth.
- Design, implement, and continuously improve end-to-end processes across study start-up, execution, data flow, and reporting to meet regulatory requirements and inspection readiness.
- Standardize workflows, templates, and best practices; eliminate redundant or low-value processes.
- Partner with Portfolio Management to establish a performance management framework (KPIs, metrics, dashboards).
- Identify and address operational bottlenecks, inefficiencies, and variability.
- Lead continuous improvement initiatives to enhance cycle times, data quality, and execution predictability; embed operational discipline and continuous learning.
- Develop and implement a comprehensive training strategy aligned to systems, processes, and ways of working; ensure role-based training and build data literacy and adherence.
- Lead enterprise change management to drive adoption of new systems/processes/operating models; manage stakeholder engagement, communication, and behavior change.
- Serve as a key integrator across Clinical Operations, Data Management, Program Management, and R&D; ensure aligned handoffs, ownership, and execution; align with Vendor & Alliance Management.
- Build and lead a high-performing Systems & Process Enablement organization; define roles/capabilities/structure; develop talent and succession planning.
Qualifications
- BS/MS in Life Sciences, Engineering, Information Systems, Business, or related field.
- 20+ years’ biotech/pharma experience with leadership in clinical systems, operations, process excellence, or digital enablement.
- Enterprise/portfolio experience supporting complex, multi-program clinical pipelines.
- Track record implementing enterprise systems and process transformations in R&D/Clinical Development (e.g., CTMS, eTMF, data platforms, reporting/analytics).
- Experience driving large-scale change management and adoption initiatives.
- Experience partnering with IT, Digital, and Data organizations to deliver scalable, user-centric solutions.
- Expertise establishing performance management frameworks (KPIs, dashboards, operational metrics).
- Strong continuous improvement mindset.
- Strong understanding of clinical development processes, data flows, and regulatory requirements.
- Strong organizational change management capability (stakeholder engagement, communication planning, adoption measurement).