Associate Director, Clinical Compliance & Records

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

Role

Associate Director, Clinical Compliance & Records, overseeing clinical trial compliance and TMF management for Amylyx's post-approval and early-phase studies in rare neurological and metabolic diseases.

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.

Requirements

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

Preferred

• Experience supporting FDA/EMA inspections, TMF system administration.
• HighValue: focus on clinical compliance and TMF in early to late-phase studies, including post-market activities; experience with Veeva Clinical; working knowledge of inspection readiness; remote work within the U.S. with periodic travel to Cambridge, MA.