Associate Director, Clinical Operations
Travere Therapeutics
August 12, 2026
On-site
San Diego Metropolitan Area
Clinical Research and Development
Position Summary:
- Associate Director, Clinical Operations accountable for execution and on-time delivery of milestones for Phase 1 clinical pharmacology clinical trials (FIH, SAD/MAD, DDI, QTc, Human ADME, food effect). Oversees daily trial activities to support internal teams and CROs.
Responsibilities:
- Lead operational execution of Phase 1 Clinical Pharmacology studies.
- Oversee PK/PD sample collection, processing, reconciliation, and shipment.
- Coordinate Safety Review Committee/Dose Escalation Committee meetings (if applicable).
- Manage operational aspects of DDI, food effect, BA/BE, QTc, and organ impairment.
- Partner with Clinical Pharmacology, Bioanalytical Sciences, Clinical Supply, Biometrics, and Nonclinical.
- Identify and mitigate operational risks unique to early-phase studies.
- Set standards/goals for Study Management Teams (SMTs); ensure accountability for missed/delayed deliverables.
- Drive SMT deliverables per approved program timelines; provide daily oversight/support to CO representatives.
- Guide SMT members to deliver per clinical operations plan.
- Escalate and resolve issues internally/externally.
- Ensure compliant SMT management per best practices/SOPs (incl. Operational Playbook and BIMO list).
- Provide input into study documents (operational feasibility of sampling schedules, confinement logistics, crossover designs; protocol, ICF templates, study plans/tools, site-facing materials).
- Oversee Phase 1 unit, central labs, and specialty vendors; manage adherence to budgets and forecast changes.
- May provide line management, coaching/mentoring to junior staff and oversight/support to CO representatives.
Education/Experience Requirements:
- Bachelor’s in life sciences, nursing, pharmacy, or related; equivalent education/experience may be considered.
- 8+ years progressive clinical trial experience; at least 2 years in a leadership role overseeing clinical trial/program execution.
- Experience with global regulatory/compliance requirements (US CFR, EU CTD, ICH E6 (R2) GCP).
- Significant experience leading Phase 1 Clinical Pharmacology studies and healthy volunteer trials.
Additional Skills/Experience:
- Courage, Community Spirit, Patient Focus, Teamwork.
- Ability to adapt to changing project plans; strong oral/written communication and ability to present to senior leadership.
- Analytical problem-solving; strong MS Office and timeline tools (MS Project/Smartsheet); clinical systems experience (e.g., IRT, eTMF).
- Track record managing complex project plans/timelines/budgets/critical paths.
- Highly organized; understands cross-functional clinical study activities.
- Previous line management preferred.
- Travel 10–20%; onsite/face-to-face in San Diego not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement with employer match, and generous paid time off.
- Base pay range: $150,000.00–$195,000.00.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.
- Associate Director, Clinical Operations accountable for execution and on-time delivery of milestones for Phase 1 clinical pharmacology clinical trials (FIH, SAD/MAD, DDI, QTc, Human ADME, food effect). Oversees daily trial activities to support internal teams and CROs.
Responsibilities:
- Lead operational execution of Phase 1 Clinical Pharmacology studies.
- Oversee PK/PD sample collection, processing, reconciliation, and shipment.
- Coordinate Safety Review Committee/Dose Escalation Committee meetings (if applicable).
- Manage operational aspects of DDI, food effect, BA/BE, QTc, and organ impairment.
- Partner with Clinical Pharmacology, Bioanalytical Sciences, Clinical Supply, Biometrics, and Nonclinical.
- Identify and mitigate operational risks unique to early-phase studies.
- Set standards/goals for Study Management Teams (SMTs); ensure accountability for missed/delayed deliverables.
- Drive SMT deliverables per approved program timelines; provide daily oversight/support to CO representatives.
- Guide SMT members to deliver per clinical operations plan.
- Escalate and resolve issues internally/externally.
- Ensure compliant SMT management per best practices/SOPs (incl. Operational Playbook and BIMO list).
- Provide input into study documents (operational feasibility of sampling schedules, confinement logistics, crossover designs; protocol, ICF templates, study plans/tools, site-facing materials).
- Oversee Phase 1 unit, central labs, and specialty vendors; manage adherence to budgets and forecast changes.
- May provide line management, coaching/mentoring to junior staff and oversight/support to CO representatives.
Education/Experience Requirements:
- Bachelor’s in life sciences, nursing, pharmacy, or related; equivalent education/experience may be considered.
- 8+ years progressive clinical trial experience; at least 2 years in a leadership role overseeing clinical trial/program execution.
- Experience with global regulatory/compliance requirements (US CFR, EU CTD, ICH E6 (R2) GCP).
- Significant experience leading Phase 1 Clinical Pharmacology studies and healthy volunteer trials.
Additional Skills/Experience:
- Courage, Community Spirit, Patient Focus, Teamwork.
- Ability to adapt to changing project plans; strong oral/written communication and ability to present to senior leadership.
- Analytical problem-solving; strong MS Office and timeline tools (MS Project/Smartsheet); clinical systems experience (e.g., IRT, eTMF).
- Track record managing complex project plans/timelines/budgets/critical paths.
- Highly organized; understands cross-functional clinical study activities.
- Previous line management preferred.
- Travel 10–20%; onsite/face-to-face in San Diego not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement with employer match, and generous paid time off.
- Base pay range: $150,000.00–$195,000.00.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.