Manager, REMS and Clinical Operations
Travere Therapeutics
4 days ago
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Position Summary:
The Manager, REMS & Clinical Operations is responsible for the execution, management, and oversight of Risk Evaluation and Mitigation Strategies (REMS) programs, and supports select clinical operations activities across Phase 1–3 clinical trials. Ensures regulatory compliance, operational excellence, and delivery of program milestones.
Key Responsibilities – REMS Program Management:
- Lead day-to-day REMS program execution; ensure alignment with regulatory requirements and corporate objectives.
- Own REMS timelines, deliverables, and milestones; identify risks and implement mitigations.
- Serve as primary contact for internal cross-functional teams and external stakeholders for REMS operations.
- Oversee REMS Administrator/vendor activities (deliverables, performance, issue resolution); support contract and budget tracking.
- Author/review/approve REMS documentation (procedures, workflows, training materials, assessment report components).
- Track, analyze, and report REMS metrics, compliance data, and KPIs.
- Establish processes for identifying, documenting, and reporting stakeholder noncompliance.
- Support audit/inspection readiness (documentation, SME participation, response coordination).
- Oversee data collection, validation, and regulatory reporting.
- Participate in/lead adverse event case review activities.
- Drive continuous improvement across REMS processes, systems, and vendor operations.
- Monitor REMS-related regulatory changes and assess operational impact.
Key Responsibilities – Clinical Operations Support:
- Provide daily oversight of internal study teams, full-service CROs, clinical sites, and third-party vendors.
- Track study progress (timelines, enrollment, deliverables) and escalate risks/delays.
- Assist with development/review of study documents and operational plans (protocols, study tools, site materials).
- Facilitate cross-functional collaboration and resolve operational issues.
- Support vendor oversight and budget tracking for assigned activities.
- Ensure study conduct aligns with GCP, regulatory requirements, and study plans.
Education/Experience Requirements:
- Bachelor’s degree or equivalent education/experience.
- 6+ years in pharmaceutical/biotech/CRO industry.
- 3–5+ years direct REMS or similar risk management program experience (preferred).
- Phase 1–3 clinical trial operations experience (required or strongly preferred).
- Working knowledge of FDA/global clinical regulations, REMS requirements, and ICH/GCP.
Additional Skills/Experience:
- Strong project/program management; ability to manage multiple priorities.
- Independently oversee vendors/external partnerships; proactively escalate risks/issues.
- Effective cross-functional communication; influence stakeholders.
- Proactive, self-starter; can take on additional tasks.
- Ability to set goals and execute with limited oversight.
- Strong issue analysis and solution development.
- Proficient MS Office and timeline tools (MS Project/Smartsheet); clinical systems experience (e.g., IRT, eTMF).
- Travel 10–20% domestic/international.
Total Rewards Offerings (as stated):
- Benefits include premium health/financial/work-life/well-being, wellness support, life insurance, disability, retirement match, and generous paid time off.
- Target base pay range: $116,000–$151,000.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.
The Manager, REMS & Clinical Operations is responsible for the execution, management, and oversight of Risk Evaluation and Mitigation Strategies (REMS) programs, and supports select clinical operations activities across Phase 1–3 clinical trials. Ensures regulatory compliance, operational excellence, and delivery of program milestones.
Key Responsibilities – REMS Program Management:
- Lead day-to-day REMS program execution; ensure alignment with regulatory requirements and corporate objectives.
- Own REMS timelines, deliverables, and milestones; identify risks and implement mitigations.
- Serve as primary contact for internal cross-functional teams and external stakeholders for REMS operations.
- Oversee REMS Administrator/vendor activities (deliverables, performance, issue resolution); support contract and budget tracking.
- Author/review/approve REMS documentation (procedures, workflows, training materials, assessment report components).
- Track, analyze, and report REMS metrics, compliance data, and KPIs.
- Establish processes for identifying, documenting, and reporting stakeholder noncompliance.
- Support audit/inspection readiness (documentation, SME participation, response coordination).
- Oversee data collection, validation, and regulatory reporting.
- Participate in/lead adverse event case review activities.
- Drive continuous improvement across REMS processes, systems, and vendor operations.
- Monitor REMS-related regulatory changes and assess operational impact.
Key Responsibilities – Clinical Operations Support:
- Provide daily oversight of internal study teams, full-service CROs, clinical sites, and third-party vendors.
- Track study progress (timelines, enrollment, deliverables) and escalate risks/delays.
- Assist with development/review of study documents and operational plans (protocols, study tools, site materials).
- Facilitate cross-functional collaboration and resolve operational issues.
- Support vendor oversight and budget tracking for assigned activities.
- Ensure study conduct aligns with GCP, regulatory requirements, and study plans.
Education/Experience Requirements:
- Bachelor’s degree or equivalent education/experience.
- 6+ years in pharmaceutical/biotech/CRO industry.
- 3–5+ years direct REMS or similar risk management program experience (preferred).
- Phase 1–3 clinical trial operations experience (required or strongly preferred).
- Working knowledge of FDA/global clinical regulations, REMS requirements, and ICH/GCP.
Additional Skills/Experience:
- Strong project/program management; ability to manage multiple priorities.
- Independently oversee vendors/external partnerships; proactively escalate risks/issues.
- Effective cross-functional communication; influence stakeholders.
- Proactive, self-starter; can take on additional tasks.
- Ability to set goals and execute with limited oversight.
- Strong issue analysis and solution development.
- Proficient MS Office and timeline tools (MS Project/Smartsheet); clinical systems experience (e.g., IRT, eTMF).
- Travel 10–20% domestic/international.
Total Rewards Offerings (as stated):
- Benefits include premium health/financial/work-life/well-being, wellness support, life insurance, disability, retirement match, and generous paid time off.
- Target base pay range: $116,000–$151,000.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.