Manage and provide daily oversight of the CTM function in the day-to-day management and study oversight of full service CROs and third-party vendors to ensure successful clinical trial implementation and execution
Ensure timelines/key deliverables (e.g. study recruitment, DBL) are on track and is accountable for assigned studies and on-time delivery of study milestones. Implements mitigations as required
As member of Clinical Operations Leadership Team (COLT) help provide strategic direction on departmental and company initiatives
Clearly articulates goals and feels comfortable holding Study Management Team (SMT) & direct reports accountable for missed/delayed deliverables
Guide other functional groups including Regulatory, Data Management, Biostatistics, Pharmacovigilance, and others to ensure alignment on operational plans for assigned studies or program. Communicate key issues and mitigations to relevant cross-functional stakeholders
Review and approves site budgets, ensures overall adherence to approved study budgets, collaborate with finance to provide input into financial reporting and financial projections. Forecast trial resource needs (external costs); responsible for review of forecast changes, management and tracking of trial budget in conjunction with CRO and contract manager
With support from senior management, appropriately escalates vendor as well as internal and external issues elevated by team and resolves issues as necessary
Excellent communication skills, both oral and written and is confident in developing materials and presenting to senior leadership (DRC, ET, PGT and BoD as applicable) as well as communicate key issues and mitigations to relevant cross-functional stakeholders
Prepares and delivers status updates to senior management as needed
Manage and communicate study status updates to senior management including overall clinical operations plan for investigational trials including timelines, internal and external resources/costs, and critical deliverables
Ensures SMT(s) are actively and compliantly managing study efforts while adhering to best practices/SOPs including the development of Operational Playbook & BIMO list
In conjunction with the CRO, tracks study status, timelines, enrollment, regulatory documentation, and site start‐up status for assigned clinical trials
Monitors resource allocation to ensure adequate staff for work required. Assists in planning for future resource needs
Provides direct line management and active coaching and mentoring to junior staff in the department as well as provides oversight and support of CO representatives in leading the SMTs and assigned areas
Provides guidance and support of the various SMT members to ensure SMT activities are delivered per the overall clinical operations plan for assigned study(ies)
Exhibits leadership behaviors by setting high standards and goals for oneself and direct reports
Provides oversight review of study protocol, ICFs, study plans
Education/Experience Requirements:
Bachelor's degree, or equivalent, in a life science, or related field of study. Equivalent combination of education and applicable job experience may be considered.
Minimum of 12 years of clinical operations experience in a pharmaceutical or CRO setting, including at least 6 years on a leadership role overseeing the execution of clinical trials or programs.
Has actively managed phase I, II a
Benefits
Vision insurance
Additional Information
Department:
106600 Clinical Operations
Location:
San Diego
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 Director, Clinical Operations is responsible for overseeing clinical trial management for several investigational trials within a development program. The individual will coordinate, track, and manage daily activities for one or multiple clinical studies led by Clinical Trial Managers (CTMs) providing oversight to both the internal project team and the CRO(s).
Travere · San Diego