Senior Director, GCP Quality

Remix Therapeutics is a clinical-stage biopharmaceutical company pioneering a new class of medicines that modulate RNA splicing to address the underlying biology of disease. Our lead program, REM-422, targets pre-mRNA splicing in oncology and represents a fundamentally differentiated approach to drug discovery. Headquartered in Watertown, MA, Remix is advancing its pipeline with the urgency and scientific rigor that patients deserve.

Position Summary:

The GCP Quality Assurance candidate will manage activities related to the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by company. The primary responsibilities will be to ensure both quality and compliance of company sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices.

Key Responsibilities:

• Write and/or review SOPs to assess consistency and compliance with regulatory requirements/internal standards and determine/ensure effective implementation across the organization.

• Provide guidance to Clinical Operations staff and other GCP-related departments, as applicable, based on interpretation of current regulations to ensure best practices including risk based management.

• Provide guidance with the identification and management of risks in clinical trial activities and monitor/evaluate risk management activities.

• Work closely with Clinical Operations and other GCP-related departments, as applicable, to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues in a timely manner, including approval of corrective action/preventative action (CAPA) plans, as necessary.

• Participate in the review of drug safety practices for clinical trial compliance.

• Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation).

• Identify need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs).

• Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process.

• Provide functional review of clinical protocols, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents.

• Assist and advise with training QA and clinical staff as necessary for GCP.

• Collaborate with applicable departmental heads to identify clinical trial and regulatory training needs of Clinical Operations (and other Clinical trial members) based on regulatory changes, process/system changes, audit findings, trends, , and assist in coordinating the training to meet the needs.