Senior Manager, Clinical Operations

Travere Therapeutics; Denver (CO); Hybrid; USD 132,000 - 172,000; Full time

Job summary

Travere Therapeutics is seeking a Senior Manager of Clinical Operations to supervise and execute clinical operations for Phase 1–3 trials. You will coordinate daily trial activities, manage CROs, sites, and vendors, and ensure adherence to study plans, SOPs and ICH/GCP.

Responsibilities include budgeting, timelines, SMT leadership, and cross-functional coordination with Biometrics and PV. The role requires global trial experience and up to 20% travel, with onsite work in San Diego and hybrid

Qualifications

• Bachelor's degree or equivalent combination of education and applicable job experience.
• 7+ years of clinical trial experience required with 2+ years managing clinical studies at a sponsor or CRO.
• Experience with global regulatory and compliance requirements (US CFR, EU CTD, ICH E6 R2).
• Phase 1-3 study experience or international studies preferred.

Responsibilities

• Oversee internal study teams, CROs, sites and vendors to ensure trial execution.
• Triage and resolve study issues; escalate as needed.
• Manage study timelines, budgets and SMT for on-time milestones.
• Coordinate cross-functional activities with Biometrics, PV, and other functions.
• Track status, enrollment, regulatory docs and site start-up for trials.
• Develop input into study documents and site-facing materials.
• Monitor CRO budgets and forecast changes with Strategic Procurement.
• Travel 10-20% domestically and internationally.

Skills

Leadership

Communication

Problem-solving

Time management

Cross-functional collaboration

Education

Bachelor's degree or equivalent

7+ years clinical trial experience

2+ years managing studies (sponsor/CRO)

Tools

MS Office

MS Project

Smartsheet

IRT/eTMF systems

Job description

Department: 106600 Clinical Operations

Location: San Diego, USA- Remote

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 Senior Manager, Clinical Operations is responsible for supervision and execution of the clinical operations for Phase 1 - 3 clinical trials. Under the guidance of Clinical Operations Management, the individual will coordinate, track, and manage daily trial activities to support both the internal project team and the Contract Research Organizations (CROs).

Responsibilities

• 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.
• Triage, resolve, or elevate study issues to Clinical Operations Management.
• Evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply understanding of study protocol(s).
• Manage entirety of assigned area or study(ies) (i.e. program timeline, budgets, study management team [SMT]) and is responsible for on-time delivery of study milestones.
• Guide other functional activities including Biometrics, PV, and others to ensure clinical study execution in compliance with study plans, SOPs, and ICH/GCP.
• Track study status, timelines, enrollment, regulatory documentation, and site start-up status (as applicable) for assigned clinical trials.
• Develop and/or provide input into clinical study documents (e.g., clinical study protocol, ICF templates, study plans/tools, and site-facing materials such as site budgets, recruitment material, etc.).
• Oversee current CRO/vendor budgets and tracks/forecast changes in conjunction with Strategic Procurement.
• Track and manage trial-related materials/supplies and laboratory samples.
• Independently leads cross functional activities in establishing and meeting SMT goals and communicate key issues and mitigations to relevant cross-functional stakeholders.
• Provide basic strategic input into areas of study management.
• Additional duties assigned as needed.

Education/Experience Requirements

• Bachelor's degree or equivalent combination of education and applicable job experience may be considered.
• 7+ years of clinical trial experience required with 2+ years of experience managing clinical studies at a sponsor or CRO.
• Experience in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH E6 (R2) GCP.
• Phase 1 -3 study experience or relevant experience including international studies is preferred.

Additional Skills/Experience

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork
• Driven, intelligent, passionate about making a difference for patients with rare diseases
• Proactive, self-starter who possesses the desire to take on additional tasks (in and out of Clinical Operations).
• Ability to establish goals for assigned studies and execute within an established timeframe.
• Ability to independently identify issues, determine cause, and propose/implement solutions.
• Proficient communication skills, both oral and written with ability to present study updates at various cross-functional meetings.
• Advanced problem-solving skills and critical thinking skills.
• Strong sense of urgency, keen attention to detail, and ability to work independently.
• Strong skills in MS Office and timeline software such as MS Project or Smartsheet. Experience with clinical systems such as IRT, eTMF, etc.
• Successful record of creating and managing complex project plans, timelines, budgets, and critical paths.
• Well organized and can effectively oversee priorities/assigned study(ies) under time and resource pressures.
• Demonstrates excellent understanding of cross functional activities and input into clinical studies.
• Ability to travel 10-20% domestically and internationally
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Total Rewards Offerings

Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.

Benefits

Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.

Compensation

Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range

$132,000.00 - $172,000.00

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.