Associate Director, Clinical Trial Disclosure and Transparency

Alnylam Pharmaceuticals   •  

Cambridge, MA

Industry: Biotech/Pharma

  •  

8 - 10 years

Posted 376 days ago

Overview:

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.  

Responsibilities:

  • ·    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 

Qualifications:

  • ·    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

Job Number:

 MW.17.0004