Associate Director, Clinical Compliance & TMF Strategy

Scorpion Therapeutics; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Amylyx is seeking an Associate Director, Clinical Compliance & Records to oversee clinical trial compliance and TMF management for post-approval and early-phase studies in rare neurological and metabolic diseases. The role leads risk assessments, CAPAs, inspection readiness, and audit support, and develops TMF strategies including eTMF processes and system migrations.

The candidate will collaborate with Clinical Operations, Quality, and Study Teams to drive process improvements and ensure

Qualifications

• Bachelor's degree in health or science field.
• 8+ years in clinical compliance or TMF roles in pharma/biotech.
• Strong knowledge of ICH-GCP, FDA guidelines, and TMF standards.
• Proficiency with Veeva systems and MS Office.

Responsibilities

• Ensure adherence to ICH-GCP, FDA, and SOPs; lead risk assessments, CAPAs, inspection readiness, and audit support.
• Develop and maintain TMF strategies, including eTMF processes, documentation quality, and system migrations.
• Collaborate with Clinical Operations, Quality, and Study Teams to drive process improvements.

Skills

Clinical compliance

TMF management

Regulatory guidelines

Audit readiness

Risk assessments

Education

Bachelor's degree in health or science

Tools

Veeva Systems

MS Office

Job description

Amylyx is seeking an Associate Director, Clinical Compliance & Records to oversee clinical trial compliance and TMF management for post-approval and early-phase studies in rare neurological and metabolic diseases. The role leads risk assessments, CAPAs, inspection readiness, and audit support, and develops TMF strategies including eTMF processes and system migrations.

The candidate will collaborate with Clinical Operations, Quality, and Study Teams to drive process improvements and ensure