Alnylam Pharmaceuticals is seeking an experienced Associate Director of Clinical Trial Disclosure and Transparency to lead, define, execute, and efficiently manage clinical trial disclosure and transparency activities. This newly created position will report to the Head of Medical Writing and will be a key player in evaluating, developing, and implementing efficient, quality compliant processes and systems to ensure overall effectiveness. In addition, this individual will create and drive the strategic roadmap, standards, and policies to meet international regulations and laws.
This individual will centralize and assume primary responsibility for the entire clinical trial disclosure and transparency process from program and protocol teams, which includes but is not limited to information gathering, management of internal review and approval process, registration, updates/maintenance, posting final results to agencies’ portals (such as clinicaltrial.gov and EudraCT), and management and oversight of data transparency deliverables.
Provides leadership and serves as subject matter expert for Clinical Trial Disclosure and Transparency activities
Monitors, communicates, and plans responses for changes in global Clinical Trial Disclosure and Transparency regulations
Collaborates with cross-functional stakeholders (Clinical Operations, Clinical Research, Patient Recruitment & Retention, Safety/PV, Biostatistics and Data Science, Regulatory Affairs, Investor Relations, and Legal) along with Contract Research Organizations (CROs)
Manages and trains internal staff and external contractors/CROs/vendors
Performs project management coordination and execution of Clinical Trial Disclosure and Transparency activities to ensure Alnylam sponsored trials are disclosed in accordance to global applicable laws, regulations, and policies
Communicates timelines, reviews protocol information, gathers additional information, prepares documentation, conducts reviews, and posts to regulatory agencies’ portals.
Ensures consistency of information posted with publications and other publically disclosed areas and creates a standard internal terminology database to improve efficiency
Updates existing registries with changes in ongoing clinical trials related to protocol amendments, site updates, recruitment status, and actual dates
Creates process for archiving registrations and results posting documentation
Creates process for data transparency deliverables
Demonstrates leadership and management of aligning stakeholders, driving decisions, and keeping requirement definition and implementations focused and on-time
Optimizes and implements Standard Operating Procedures (SOPs), policies, processes, communication, and infrastructure to function as an quality driven organization
Identifies and evaluates clinical trial disclosure software and systems, develops business cases, and collaborates on implementation to improve effectiveness
Determines approach and process for answering external inquiries around clinical trial results
Assists trial teams, expertise areas, and management with questions regarding public results disclosure and trains the organization on disclosure process
Develops further understanding of trends, regulations, and benchmarking
Generates and establishes metrics / KPIs for processes, analysis, and implements routine reporting
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment
Bachelor degree in science, health profession, or communication
7+ years working in pharmaceutical, biotechnology, health care, or medical industry
Demonstrated experience along with sound practical understanding of clinical trial disclosure and data transparency activities and regulations
Desire and aptitude to create and execute clinical disclosure and transparency procedures
Knowledge of clinical development, regulatory affairs, and/or clinical trial execution processes, including the phases, protocol design through regulatory submissions, and scientific methodology
Regulatory knowledge, including Good Clinical Practices (GCPs), ICH guidelines, and trial disclosure requirements
Strong Project Management experience
Ability to communicate and build relationships at all levels within the organization
Strong thinker with good facilitation skills supported by excellent interpersonal competencies (communication, leadership, influencing)
Experience working in a fast-paced entrepreneurial environment
Alnylam is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of patients who have limited or inadequate treatment options. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of debilitating diseases with high unmet medi...cal need. Alnylam was founded in 2002 on a bold vision to turn scientific possibility into reality, which is now marked by its robust discovery platform and deep pipeline of investigational medicines, including 4 programs in late-stage clinical development.