Associate Director, Clinical Operations
Travere Therapeutics
September 02, 2026
On-site
San Diego Metropolitan Area
Operations
Position Summary:
Associate Director, Clinical Operations accountable for execution and on-time delivery of milestones for Phase 1 clinical pharmacology trials (FIH, SAD/MAD, DDI, QTc, Human ADME, food effect). Oversees daily trial activities for 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/mitigate early-phase operational risks; manage SMT standards and deliverables.
- Drive key SMT deliverables; provide daily oversight/support and issue escalation/resolution.
- Ensure compliant best practices/SOPs (e.g., Operational Playbook and BIMO list).
- Provide operational feasibility input for intensive sampling, confinement logistics, and crossover designs (protocol, ICFs, study plans/tools, site materials).
- Oversee Phase 1 unit, central labs, and specialty vendors; adhere to budgets/forecast changes.
- May provide line management/mentoring to junior staff.
Qualifications:
- Bachelor’s in life sciences, nursing, pharmacy, or related field (equivalent education/experience considered).
- 8+ years clinical trial experience; 2+ years in a leadership role overseeing execution.
- Global regulatory/compliance experience (US CFR, EU CTD, ICH E6(R2) GCP).
- Significant experience leading Phase 1 Clinical Pharmacology and healthy volunteer trials.
Skills:
- Strong communication; analytical triage; MS Office, MS Project/Smartsheet; clinical systems (IRT, eTMF).
- Track record managing project plans/timelines/budgets/critical paths; cross-functional understanding.
- Line management preferred; travel 10–20%; on-site/face-to-face in San Diego.
Benefits:
- Premium health/financial/work-life well-being, life insurance, disability, retirement with match, generous paid time off.
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 trials (FIH, SAD/MAD, DDI, QTc, Human ADME, food effect). Oversees daily trial activities for 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/mitigate early-phase operational risks; manage SMT standards and deliverables.
- Drive key SMT deliverables; provide daily oversight/support and issue escalation/resolution.
- Ensure compliant best practices/SOPs (e.g., Operational Playbook and BIMO list).
- Provide operational feasibility input for intensive sampling, confinement logistics, and crossover designs (protocol, ICFs, study plans/tools, site materials).
- Oversee Phase 1 unit, central labs, and specialty vendors; adhere to budgets/forecast changes.
- May provide line management/mentoring to junior staff.
Qualifications:
- Bachelor’s in life sciences, nursing, pharmacy, or related field (equivalent education/experience considered).
- 8+ years clinical trial experience; 2+ years in a leadership role overseeing execution.
- Global regulatory/compliance experience (US CFR, EU CTD, ICH E6(R2) GCP).
- Significant experience leading Phase 1 Clinical Pharmacology and healthy volunteer trials.
Skills:
- Strong communication; analytical triage; MS Office, MS Project/Smartsheet; clinical systems (IRT, eTMF).
- Track record managing project plans/timelines/budgets/critical paths; cross-functional understanding.
- Line management preferred; travel 10–20%; on-site/face-to-face in San Diego.
Benefits:
- Premium health/financial/work-life well-being, life insurance, disability, retirement with match, generous paid time off.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.