Manager, REMS and Clinical Operations

Manager, Rems & Clinical Operations

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Position Summary:

The Manager, REMS & Clinical Operations is responsible for the execution, management, and oversight of Risk Evaluation and Mitigation Strategies (REMS) programs, while also supporting select clinical operations activities across Phase 1–3 clinical trials. This role translates REMS strategy into execution, ensuring regulatory compliance, operational excellence, and delivery of program milestones. In parallel, the role contributes to clinical study execution through vendor oversight, cross-functional leadership, and management of key operational activities.

Key Responsibilities – REMS Program Management:

• Lead day-to-day management and execution of REMS programs, ensuring alignment with regulatory requirements and corporate objectives.
• Own operational timelines, deliverables, and milestones for REMS programs, proactively identifying risks and implementing mitigation strategies.
• Serve as a primary point of contact for internal cross-functional teams and support external stakeholder interactions related to REMS operations.
• Oversee REMS Administrator/vendor activities, including deliverables, performance management, and issue resolution, support contract and budget tracking.
• Author, review, and approve REMS-related documentation, including procedures, workflows, training materials, and assessment report components.
• Lead tracking, analysis, and reporting of REMS program metrics, compliance data, and key performance indicators.
• Establish and manage processes for identifying, documenting, and reporting stakeholder noncompliance.
• Support and lead elements of audit and inspection readiness, including documentation, SME participation, and response coordination.
• Oversee data collection, validation, and reporting to ensure accuracy and regulatory compliance.
• Participate in and/or lead adverse event case review activities as required.
• Identify and drive continuous improvement initiatives across REMS processes, systems, and vendor operations.
• Monitor regulatory landscape for REMS-related changes and assess operational impact, escalating strategic considerations as appropriate.

Key Responsibilities – Clinical Operations Support:

• Manage and provide daily oversight of internal study teams, full-service CROs, clinical sites and third-party vendors to ensure successful clinical trial implementation and execution.
• Track study progress (e.g., timelines, enrollment, deliverables) and escalate risks or delays.
• Assist in the development and review of study documents and operational plans (e.g., protocols, study tools, site materials).
• Contribute to study execution by facilitating cross-functional collaboration and resolving operational issues.
• Support vendor oversight and budget tracking for assigned clinical activities.
• Ensure study conduct aligns with GCP, regulatory requirements, and study plans.

Education/Experience Requirements:

• Bachelor's degree or equivalent combination of education and applicable job experience may be considered.
• 6+ years of experience in pharmaceutical, biotechnology, or CRO industry.
• 3-5+ years of direct experience supporting REMS or similar risk management programs preferred.
• Experience in clinical trial operations (Phase 1–3) required or strongly preferred.
• Working knowledge of FDA regulations, global clinical regulations and REMS requirements, as well as ICH/GCP guidelines.

Additional Skills/Experience:

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Strong project and program management skills with the ability to manage multiple priorities across REMS and clinical activities.
• Demonstrated ability to independently oversee vendors and manage external partnerships and proactively escalate risks or issues.
• Effective communication skills with ability to influence cross-functional teams.
• Proactive, self-starter who possesses the desire to take on additional tasks (in and out Clinical Operations).
• Ability to establish goals for multiple priorities/assigned studies and can execute within an established timeframe with limited oversight.
• Ability to identify issues, determine cause, and propose solutions with limited oversight.
• Proficient communication skills, both oral and written with ability to present study updates at various cross-functional meetings.
• Proficient problem-solving skills and critical thinking skills.
• Strong sense of urgency, keen attention to detail, and ability to work independently.
• Should have strong skills in MS Office and timeline software such as MS Project or Smartsheet. Experience with clinical systems such as IRT, eTMF, etc.
• Demonstrates excellent understanding of cross functional activities and input into clinical studies.
• Ability to travel 10-20% domestic and internationally.

Travere is an EEO/AA/Veteran/Disability Employer