Senior Manager, Clinical Trial Disclosure and Transparency
Alnylam Pharmaceuticals
Summary
The Senior Manager, Clinical Trial Disclosure and Transparency is a key member of the Clinical Trial Disclosure and Transparency (CTDT) team working within the Alnylam Medical Writing Expertise Area. The Senior Manager, CTDT is responsible for expertly carrying out operations for the accurate and timely disclosure of Alnylam trial information to regulatory agencies and publicly accessible clinical trial registry websites.
Job description
Responsibilities
- Ensure accurate, timely, consistent, and complete disclosure of clinical trial data in alignment with global, regional, and local regulatory requirements.
- Serve as subject matter expert for CTDT registration and results regulations.
- Independently plan and prepare protocol registration and results records for public registries according to current guidelines and Alnylam policy, producing high quality and on-time writing deliverables; maintain records as per regulation.
- Facilitate/manage efficient review and finalization process for all protocol and results record content with key stakeholders.
- Collaborate effectively with all stakeholders including Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Medical Affairs, Safety, Quality, and Corporate Communications, 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.
- Oversee interns, contractors, or training of more junior CTDT team members.
- Serve as super-user for the disclosure and transparency tracking, logging and authoring tool.
- Support the assessment and implementation of AI projects for registration and results posting work.
- Contribute 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.
- Represent CTDT on project teams and/or CTDT collaborative initiatives.
Qualifications
- Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred.
- 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 CTIS.
- Detail-oriented with excellent inter-personal 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.
- Experience with AI such as CoPilot and other AI applications.
Requirements
- Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise
- 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 CTIS
- Detail-oriented with excellent inter-personal 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
- Experience with AI such as CoPilot and other AI applications
Benefits
- Medical, Dental & Vision
- Life & Disability Insurance
- Lifestyle Reimbursement Program
- Flexible Spending Accounts
- Health Savings Accounts
- 401(k) Matching
- Paid Time Off
- Wellness Days
- Holidays
- Company Recharge Breaks
- Family Resources
- Leave
Company overview
Alnylam Pharmaceuticals is a pioneering American biopharmaceutical company and the global leader in RNA interference (RNAi) therapeutics. Founded in 2002 and headquartered in Cambridge, Massachusetts, Alnylam has revolutionized the field of genetic medicine by developing innovative treatments that 'silence' disease-causing genes. The company achieved a historic milestone in 2018 with the approval of Onpattro (patisiran), the world's first RNAi therapeutic, which treats hereditary transthyretin-mediated amyloidosis. Since then, Alnylam has successfully commercialized five additional RNAi medicines targeting rare genetic disorders including acute hepatic porphyria, primary hyperoxaluria type 1, and transthyretin amyloidosis. With over 2,100 employees worldwide, Alnylam maintains a robust pipeline of investigational therapies across genetic medicines, cardiometabolic diseases, and hepatic infectious diseases. The company's groundbreaking work has established RNAi as a clinically validated therapeutic platform, earning recognition as one of the most innovative biopharmaceutical companies and consistently ranking as a top employer in the life sciences industry.