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).
Responsibilities:
- 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 and III studies and served as a clinical operations lead for multiple studies or within a program, or closely relevant experience is preferred.
- Global trial management experience preferred.
Additional Skills/Experience:
- The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
- Experience in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP
- Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written
- Ability to continually evaluate a variety of unpredictable scenarios and achieve program timelines while being able to apply understanding of the overall program strategy
- Advanced ability to think analytically to quickly triage multiple solutions to an issue, determine best path forward, and apply solutions across multiple studies within a program as needed
- Ability to provide input into overall clinical strategy and potentially other workstreams where clinical feedback is required
- A strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures
- Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
- Successful record of creating and managing complex project plans, timelines, budgets, and critical paths
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
- Ability to identify and plan for potential risks, implement mitigation strategy as needed
- Preferred previous line management experience with the ability to effectively manage performance, engage team members, provide coaching, and respond to situations affecting staff
- Ability to travel 10-20 % domestic and internationally
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.
About Travere Therapeutics
At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit [travere.com](http://travere.com/).
