Alnylam Pharmaceuticals · 1 day ago
Senior Manager, Clinical Trial Disclosure and Transparency
Boston, MA
Full-time
Onsite
Senior Level
6+ years expAlnylam Pharmaceuticals is seeking a Senior Manager for their Clinical Trial Disclosure and Transparency team. This role is responsible for ensuring the accurate and timely disclosure of clinical trial information to regulatory agencies and managing various disclosure activities in compliance with regulatory requirements.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Ensure accurate, timely, consistent, and complete disclosure of clinical trial information in alignment with global, regional, and local regulatory requirements
Independently plan and prepare data publication packages (e.g. Policy 0070, PRCI) to current guidelines, working closely with expert vendors to produce high quality and on-time deliverables
Oversee, track and facilitate Policy 0043 requests, collaborating with key Subject Matter Experts, vendors and regulatory stakeholders under short deadlines to ensure timely submissions. Maintain and continue to develop the Alnylam CCI library
Facilitate/manage the efficient review and finalization process for all anonymization packages and document redaction content with key stakeholders
Oversee or support in other key disclosure activities including redaction of clinical documents in preparation for EMA CTA submissions; planning and authoring of protocol registration records, and planning and authoring of results records
Serve as systems expert with deep understanding of Alnylam’s transparency tracking and authoring tool, clinical trial website backend, and data sharing platform
Enhance and maintain the Alnylam Data Sharing request process, facilitating Data Sharing request review and decision-making
Serve as subject matter expert for CTDT requirements and regulations. Maintain continuous knowledge of regulatory requirements, guidance, and industry trends related to clinical trial disclosure
Represent CTDT on project teams and/or CTDT collaborative initiatives
Collaborate effectively with all stakeholders including Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Clinical Research, Medical Affairs, Safety, Quality, Corporate Communications, and Data Sciences as well as with external stakeholders, bringing specialized knowledge of global disclosure requirements and standards to study teams, providing guidance on best practices
Contribute to or have ownership of the development of training manuals, working instructions or standard operating procedures (SOPs)
Support or lead process improvement initiatives for CTDT as required
Oversee interns, contractors, or training of more junior CTDT team members
Qualification
Required
Bachelor's degree in Life Science
6+ years of experience in Clinical Trial Disclosure and Transparency in the sponsor and/or CRO setting
Expert understanding of global regulatory requirements for clinical trial disclosure
Superior working knowledge and familiarity with ClinicalTrials.gov and EudraCT/EU CTR
Detail-oriented with excellent interpersonal and communication skills
Strong ability to work both independently and with a team in a global cross-cultural environment
Successful track record of managing multiple projects in a fast-paced and deadline-driven environment
Excellent communication skills and ability to deliver clear messages to varied audiences
In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process
Impeccable attention to detail and ability to complete writing assignments in a timely manner
Must be proficient with Microsoft Windows, Word, Excel, Power Point, and other Office applications
Preferred
Advanced degree and/or professional certification/credentials preferred
Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
2025-12-22
2025-12-20
Company data provided by crunchbase