Overview
Pipeline Delivery Systems & Process Enablement is a strategic leadership role responsible for building and scaling a seamless, integrated ecosystem of systems, data, and operational processes that enable efficient and predictable delivery of Alnylam’s development pipeline. This leader will drive operational excellence across Clinical Operations, Data Management, and Program Management, ensuring that systems and processes are standardized, user‑centric, and enable real‑time, data‑driven decision‑making. Through strong leadership in process design, training, and change management, this role ensures consistent adoption and sustained performance, accelerating the delivery of RNAi therapeutics to patients.
Key Responsibilities
Systems & Digital Enablement Strategy
* 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, enabling speed, quality, transparency, and informed program and portfolio decision‑making.
Process Excellence & Standardization
* Design, implement, and continuously improve end‑to‑end processes across study start‑up, execution, data flow, and reporting ensuring processes are aligned with regulatory requirements and inspection readiness expectations.
* Drive standardization of workflows, templates, and best practices across Pipeline Delivery functions, simplifying complexity by eliminating redundant or low‑value processes.
Operational Performance & Continuous Improvement
* Partner with Portfolio Management to establish a performance management framework (KPIs, metrics, dashboards) to monitor process effectiveness and system utilization.
* Identify and address operational bottlenecks, inefficiencies, and variability.
* Lead continuous improvement initiatives to enhance cycle times, data quality, and execution predictability.
* Embed a culture of operational discipline and continuous learning.
Training & Capability Building
* Develop and implement a comprehensive training strategy aligned to systems, processes, and ways of working.
* Ensure role‑based training enables teams to operate effectively within the Pipeline Delivery model.
* Build capability in data literacy, system utilization, and process adherence.
* Continuously evaluate and evolve training approaches to drive effectiveness and engagement.
Change Management & Adoption
* Lead enterprise change management to drive adoption of new systems, processes, and operating models, using structured approaches to stakeholder engagement, communication, and behavior change.
* Champion user experience and organizational readiness, ensuring changes are implemented with minimal disruption and sustained adoption over time.
Cross‑Functional Integration
* Serve as a key integrator across Clinical Operations, Data Management, Program Management, and broader R&D functions and partner closely with Portfolio Management to ensure systems support planning, governance, and performance tracking.
* Ensure systems and processes enable seamless handoffs, clear ownership, and aligned execution.
* Align with Vendor & Alliance Management to ensure external partners operate within defined systems and processes.
Organizational Leadership
* Build and lead a high‑performing Systems & Process Enablement organization fostering a culture of innovation, accountability, and continuous improvement.
* Define roles, capabilities, and structure required to support a scalable Pipeline Delivery model.
* Develop talent and ensure strong succession planning.
Key Success Metrics
* Enterprise adoption and impact: Effective utilization of systems and standardized processes across Pipeline Delivery, driving compliance, improved data quality, and faster, more informed decision‑making.
* Operational performance and transformation success: Reduced cycle times and inefficiencies through strong training effectiveness, user proficiency, and successful delivery and sustained adoption of transformation initiatives.
Qualifications
* BS/MS in Life Sciences, Engineering, Information Systems, Business, or a related field.
* 20+ years of experience in biotech/pharma, with leadership roles in clinical systems, operations, process excellence, or digital enablement.
* Demonstrated experience operating at the enterprise or portfolio level, supporting complex, multi‑program clinical pipelines.
* Proven track record implementing enterprise systems and process transformations in R&D or Clinical Development (e.g., CTMS, eTMF, data platforms, reporting and analytics).
* Experience driving large‑scale change management and adoption initiatives.
* Experience partnering closely with IT, Digital, and Data organizations to deliver scalable, user‑centric solutions.
* Expertise establishing performance management frameworks, including KPIs, dashboards, and operational metrics to support portfolio and program decision‑making.
* Strong continuous improvement mindset, with experience leading initiatives that improve cycle times, data quality, and execution predictability.
* Strong understanding of clinical development processes, data flows, and regulatory requirements.
* Strong capability in organizational change management, including stakeholder engagement, communication planning, and adoption measurement.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
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