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

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. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

Equal Employment Opportunity

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.