Associate Director, Clinical Compliance & Records
Amylyx Pharmaceuticals · Cambridge, MA
Posted about 3 months ago
or apply directly on Amylyx Pharmaceuticals's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 81 days Amylyx Pharmaceuticals's roles stay open a median of 82 days
- Reposted
- No
- Salary listed
- No 0% of Amylyx Pharmaceuticals's roles list one
- Ghost-job risk at Amylyx Pharmaceuticals
- high 29 stale, 3 reposted of 29 open
- Hiring momentum
- 42 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-10-24
Measured from postings appearing on and disappearing from Amylyx Pharmaceuticals's own greenhouse board since 2026-08-03. Full hiring picture for Amylyx Pharmaceuticals.
About this role
The Associate Director, Clinical Compliance & Records at Amylyx will lead compliance activities for clinical trials, ensuring adherence to SOPs, ICH/GCP standards, and global regulations. This role involves strategic guidance to Study Management Teams, risk assessment, and driving continuous improvement initiatives. The position requires collaboration across functions to support compliance documentation and audit readiness while serving as a subject matter expert in clinical compliance.
- benefits
- 1/5
- freshness
- 1/5
- career value
- 4/5
- role clarity
- 4/5
- pay transparency
- 0/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Amylyx Pharmaceuticals as an employer.
What you need
- Bachelor’s degree in a scientific or health-related discipline
- 8+ years of experience in the pharmaceutical or biotechnology industry, with a focus on Clinical Compliance and Clinical Operations
- Strong knowledge of ICH-GCP guidelines and FDA regulatory requirements across clinical phases
- Experience working with clinical and electronic quality management systems (QMS) such as Veeva Clinical and Veeva Quality
- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, SharePoint)
- Strong collaboration and stakeholder management skills
Nice to have
- Experience supporting regulatory inspections (e.g., FDA, EMA, MHRA)
- Experience serving as a training administrator in electronic learning management systems (e.g., Veeva Quality Training, Veeva Study Training)
- Experience supporting study teams with developing, facilitating, and maintaining Risk Assessment Categorization Tools (RACTs), risk registers, and risk logs to identify, assess, monitor, and mitigate clinical trial risks
Worth weighing
- Remote work is supported, but applicants from certain states are not considered.
- Travel to the corporate location in Cambridge, MA is required several times a year.
- Compensation is based on experience and internal equity, with a specified pay range.
- No specific benefits or perks are listed in the posting.
Summarised from Amylyx Pharmaceuticals's posting. Read the full original.
Listed by Amylyx Pharmaceuticals on their greenhouse job board, last confirmed open on 2026-10-24. PitchMeAI is not the employer.
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