Director, Technical Solutions

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people.

Responsibilities

• Designs and leads Quantitative Sciences data and analytics systems strategy and/or technical development initiatives including systems and technology integration, data sharing, analysis, transfer/access and storage platforms or utilities.
• Establishes Quantitative Sciences technical direction, standards, and governance policies for analytical solutions and platforms, as well as best practices for efficient and inspection-ready delivery across the data flow.
• Lead the strategic vision, implementation, and continuous evolution of the AWS cloud platform supporting Statistical Programming, Biostatistics, Epidemiology, Data Science, and Clinical Development functions.
• Oversee the design, deployment, validation, and lifecycle management of AWS-hosted programming and analytics environments within regulated GxP settings.
• Promotes technical innovation to drive the development of data, analysis and visualization solutions within a clinical data environment.
• Develop strategies in collaboration with Data Science team for integrating generative AI and other advanced analytics tools into statistical programming workflows while ensuring regulatory compliance and appropriate validation.
• Leads technical assessments of vendor products or new technologies; manages and establishes relationships with technical vendors to support business needs.
• Collaborates with Clinical Development Operations, IT and other functional leaders to ensure organizational effectiveness/efficiencies from systems and technology platforms.
• Partners with the IT Validation/QA organizations to ensure compliance of clinical data systems and processes to regulatory requirements.
• Collaborates with IT on technical project prioritization, forecasting, estimation, and budgeting.
• Facilitates change management activities and training for key systems and processes.

Requirements

• Minimum 15 years’ industry experience (Pharmaceutical, Biotech, CRO) leading technical projects and/or supervising teams to deliver data/analytics solutions.
• Demonstrated technical expertise with clinical databases, AWS/EDC platforms, data imports/integrations, data analytics platforms and/or data visualization tools; advanced programming and analytical skills using SAS, R and Python an asset.
• Experience driving data solutions projects or system implementations (e.g., data dashboards, R/SAS/data analytics infrastructure, data warehousing, data visualization and/or risk-based data review tools/systems) with clinical team members.
• Demonstrated experience working with IT and cross-functional counterparts in evaluating and implementing clinical data systems, constructing technical business requirements, specifications and supporting validation documentation.
• Experience managing technical teams (FTEs, Functional Service Providers or vendors).
• Demonstrated leadership in implementing solutions within the clinical data flow, understanding of CDISC standards, and technologies/utilities in support of Quantitative Sciences data flow (from CRF to CSR).
• Detailed knowledge of data management, statistical programming environments, processes, procedures, and roles.
• Experience developing SOPs, Standards or implementing technical best practices.
• Experience overseeing vendors in the delivery of technical solutions, including development of quality and performance metrics.
• Excellent written and oral presentation and interpersonal, organizational, analytical, project management and multi-tasking skills.
• Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, Validation requirements.
• Bachelor’s Degree required in areas of computer science, statistics, mathematics or information sciences; MBA, advanced degree and/or Project Management certification preferred.
• Clear alignment with Alnylam Core Values:
  • Commitment to People
  • Innovation and Discovery
  • Sense of Urgency
  • Open Culture
  • Passion for Excellence

Pay

U.S. Pay Range $200,700.00 - $271,500.00. The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Benefits

• Comprehensive benefits including medical, dental, and vision coverage.
• Life and disability insurance.
• A lifestyle reimbursement program.
• Flexible spending and health savings accounts.
• 401(k) with a generous company match.
• Paid time off, wellness days, holidays, and two company-wide recharge breaks.
• Generous family resources and leave.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers.