Senior Director, Clinical Operations
Travere Therapeutics
August 15, 2026
On-site
San Diego Metropolitan Area
Operations
Position Summary:
The Senior Director, Clinical Operations oversees clinical trial management for several investigational trials within a development program. Coordinates and manages daily activities for one or more clinical studies led by Clinical Trial Managers (CTMs), with oversight of internal teams and CRO(s).
Responsibilities:
- Provide daily oversight of CTM function and full-service CRO/third-party vendors to ensure successful trial implementation.
- Ensure timelines and key deliverables (e.g., study recruitment, DBL) are on track; implement mitigations as needed.
- Serve on the Clinical Operations Leadership Team (COLT) to provide strategic direction.
- Hold Study Management Team (SMT) and direct reports accountable for missed/delayed deliverables.
- Align cross-functional groups (Regulatory, Data Management, Biostatistics, Pharmacovigilance, etc.) and communicate issues/mitigations.
- Review/approve site budgets; ensure adherence; collaborate with finance; forecast trial resource needs; track budget with CRO/contract manager.
- Escalate and resolve internal/external issues as needed.
- Present materials and deliver status updates to senior leadership.
- Track enrollment, regulatory documentation, and site start-up status; ensure SMT compliance with SOPs/best practices (Operational Playbook & BIMO).
- Manage resource allocation; coach/mentor junior staff and provide oversight to CO representatives.
- Provide oversight review of protocol, ICFs, and study plans.
Qualifications:
- Bachelor’s degree (life sciences/related) or equivalent.
- 12+ years clinical operations experience (pharma or CRO), including 6+ years leadership overseeing trial/program execution.
- Managed Phase I/II/III studies; lead multiple studies or programs (preferred: global trial management).
Additional Skills/Experience (Required/Preferred):
- Knowledge of global regulatory/compliance requirements (US CFR, EU CTD, ICH GCP).
- Strong communication, analytical thinking, risk identification/mitigation, multi-tasking, and urgency.
- Track record creating/managing complex project plans, timelines, budgets, and critical paths.
- Preferred line management experience.
- Travel 10–20% domestic/international.
Benefits (as stated):
- Premium health, life insurance, disability, retirement with employer match, generous paid time off, wellness/employee support, and work-life/well-being offerings.
Application Instructions:
- Applications accepted on an ongoing basis until a candidate is selected.
- For reasonable accommodation with the online application/interview/hiring process: accommodations@travere.com.
The Senior Director, Clinical Operations oversees clinical trial management for several investigational trials within a development program. Coordinates and manages daily activities for one or more clinical studies led by Clinical Trial Managers (CTMs), with oversight of internal teams and CRO(s).
Responsibilities:
- Provide daily oversight of CTM function and full-service CRO/third-party vendors to ensure successful trial implementation.
- Ensure timelines and key deliverables (e.g., study recruitment, DBL) are on track; implement mitigations as needed.
- Serve on the Clinical Operations Leadership Team (COLT) to provide strategic direction.
- Hold Study Management Team (SMT) and direct reports accountable for missed/delayed deliverables.
- Align cross-functional groups (Regulatory, Data Management, Biostatistics, Pharmacovigilance, etc.) and communicate issues/mitigations.
- Review/approve site budgets; ensure adherence; collaborate with finance; forecast trial resource needs; track budget with CRO/contract manager.
- Escalate and resolve internal/external issues as needed.
- Present materials and deliver status updates to senior leadership.
- Track enrollment, regulatory documentation, and site start-up status; ensure SMT compliance with SOPs/best practices (Operational Playbook & BIMO).
- Manage resource allocation; coach/mentor junior staff and provide oversight to CO representatives.
- Provide oversight review of protocol, ICFs, and study plans.
Qualifications:
- Bachelor’s degree (life sciences/related) or equivalent.
- 12+ years clinical operations experience (pharma or CRO), including 6+ years leadership overseeing trial/program execution.
- Managed Phase I/II/III studies; lead multiple studies or programs (preferred: global trial management).
Additional Skills/Experience (Required/Preferred):
- Knowledge of global regulatory/compliance requirements (US CFR, EU CTD, ICH GCP).
- Strong communication, analytical thinking, risk identification/mitigation, multi-tasking, and urgency.
- Track record creating/managing complex project plans, timelines, budgets, and critical paths.
- Preferred line management experience.
- Travel 10–20% domestic/international.
Benefits (as stated):
- Premium health, life insurance, disability, retirement with employer match, generous paid time off, wellness/employee support, and work-life/well-being offerings.
Application Instructions:
- Applications accepted on an ongoing basis until a candidate is selected.
- For reasonable accommodation with the online application/interview/hiring process: accommodations@travere.com.