Director, Clinical Data Solutions

Director, Clinical Data Solutions

Overview

Alnylam Pharmaceuticals is seeking a Director, Clinical Data Solutions, to lead our clinical data management transformation efforts. This role provides strategic leadership and direction for the planning, execution, and governance of in-house clinical data management and database programming activities across global clinical development programs. This role will design and deploy the company's internal clinical data management operating model and will be responsible for designing the future state and overseeing implementation. This role will also ensure the collection, standardization, integration, and quality of clinical trial data through advanced technology solutions, regulatory compliance, and cross-functional collaboration. The position is within the Data Science, Statistics, and Epidemiology expertise area (DSSE) and reports to the head of Clinical Data Management.

Key Responsibilities

• Strategic Leadership
  • Support the design and own the implementation of the new internalized operating model for clinical data management, including establishing the resource plan, building the internal team, assessing required tools and technology providers, and revising existing SOPs and documentation to reflect the in-house strategy. The Director will initiate all the functional workstreams, e.g. HR, IT, Learning, etc., needed to establish a data management operating model focused on scalability, quality, compliance, and digital enablement.
  • Lead continuous improvement initiatives, transformation programs, and system enhancements related to in-house data management operations.
• Operational Excellence
  • Lead data operations activities, including oversight of Functional Services Providers (FSPs) and vendors.
  • Design the process and quality framework for clinical data cleaning and medical coding
  • Oversee development, validation, and maintenance of EDC database builds for in-house clinical studies, including external data integrations
  • Ensure timely, high-quality, and regulatory-compliant data deliverables for submissions and inspections.
  • Define and track departmental KPIs and operational metrics for performance monitoring and continuous improvement.
  • Identify operational risks and implement mitigation strategies.
• People & Resource Management
  • Supervise, mentor, and develop high-performing teams across global regions, including lead data managers, clinical data managers, database developers, clinical programmers, external data specialists, and coders
  • Define new roles and upskill staff to meet demands of the redesigned operating model.
  • Ensure proper resource planning, workload balancing, and succession planning.
• Cross-Functional Collaboration
  • Serve as a subject matter expert and strategic partner to Clinical Operations, Statistical Programming, Biostatistics, Epidemiology, Regulatory, Global Patient Safety & Risk Management, QA and IT.
  • Demonstrate stakeholder management skills with a proven ability to align cross-functional teams as the new operational model is implemented.
  • Influence cross-functional initiatives, issue resolution, and process optimization.
• Governance & Compliance
  • Oversee maintenance and training of SOPs, work instructions, data standards, and quality oversight tools for in-house data management processes.
  • Prepare for audits, inspections, and regulatory interactions regarding data integrity and compliance.
  • Maintain and govern standard eCRFs, eLibrary, and related documentation
  • Implement quality control measures aligned with ICH-GCP, 21 CFR Part 11, and GDPR
• Technology & Innovation
  • Champion implementation and adoption of advanced platforms (EDC, eCOA, clinical data warehouses, data visualization tools).
• Identify operational risks and implement mitigation strategies.
  • Collaborate with internal IT and Clinical Operations teams to implement scalable, interoperable systems.

Qualifications

• Bachelor's or advanced degree, preferably in Life Sciences, Computer Science, Data Science, or related field.
• At least 15 years of clinical data management and associated technical experience within pharmaceutical, biotech, or CRO settings.
• At least 5 years of leadership experience managing global teams and clinical systems.
• Strong technical expertise in databases, EDC platforms specifically Medidata Rave (required), data imports/integrations; SAS and/or SQL programming.
• Hands-on experience in technologies such as Medidata modules (Rave, Coder, Safety Gateway, tSDV, eCOA), Veeva eTMF, eClinical Solutions elluminate, Spotfire.
• Deep knowledge of clinical trial systems, data lifecycle, data standards (CDISC, SDTM, CDASH, ADaM), and regulatory requirements.
• Experience using standardized medical terminology and dictionaries including MedDRA and WHODrug
• Understanding of global regulations and guidelines (e.g., FDA, EMA, MHRA, PMDA) applicable to clinical development
• Proven track record of building data management operations and successful clinical data strategy execution.
• Strong project management, vendor oversight, and change management skills.
• Excellent interpersonal, leadership, and communication skills.
• PMP certification, MBA, Lean Six Sigma or other relevant certifications preferred but not required.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

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. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.