Senior Manager, Clinical Operations

Department:

Location:

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 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 escalate 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 startup 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:

• Bachelors 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 Traveres 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:

*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 candidates 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 . 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.