New · posted Nov 13
Alnylam Pharmaceuticals · Biotechnology
Senior Manager, Clinical Trial Disclosure and Transparency
- United States
- On-site
- Full-time
- Manager
The role
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.
The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
What you need
- 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.
What you'll do
- 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 and
- 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.
Pay and benefits
$140,400 – $190,000 a year
Employer providedMedical, dental, and vision coverage
Life and disability insurance
401(k) with company match
Paid time off and wellness days
Annual bonus and equity eligibility
Family resources and leave
Where you'll work
United StatesOn-siteOpen in Maps (opens in a new tab)
From the posting
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.
Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
U.S. Pay Range
$140,400—$190,000 USD
Equal opportunity, accessibility and legal noticesAlnylam Pharmaceuticals's statements, word for word
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.
Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.
Job intelligence
The context around this role
Live data · November 13, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $140,400 | — | $190,000 |
This role: Alnylam Pharmaceuticals's own published range.
Career trajectory
Where this role sits in Clinical Regulatory Compliance
The general path across 9 open Clinical Regulatory Compliance roles on Regulatory Jobs, with the titles they carry most. Not Alnylam's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Documentation and SOPs7
- Clinical trial conduct7
- GMP and compliance3
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Regulatory Compliance work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTISNamed in the posting
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.govNamed in the posting
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
Company hiring pulse
Alnylam on Regulatory Jobs
- 15
- Open roles
- 15
- Distinct roles
- 4
- Locations
By discipline
- Clinical9 60%
- Regulatory3 20%
- Quality3 20%
By level
- Director9 60%
- Manager2 13%
- Associate & Specialist2 13%
More roles at Alnylam
- View role
Director, Pharmacovigilance & Safety Technology
Cambridge, MA · HybridDirectorBiotechnology$187K
- View role
Vice President, Head of Pharmacovigilance Operations, Innovation & Analytics
Cambridge, MA +1 more · HybridVP & ExecutiveBiotechnology$289K
- View role
Director, Clinical Research- Benign Hematology
Cambridge, MA · HybridDirectorBiotechnologySalary not listed
- View role
Director, Clinical Science
Cambridge, MA · HybridDirectorBiotechnology$206K
Senior Manager, Clinical Trial Disclosure and Transparency at Alnylam
Open until filled. $140K–$190K a year, employer provided.