Associate Director, Clinical Operations

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 Associate Director, Clinical Operations is accountable for the execution and on-time delivery of milestones for Phase 1 clinical pharmacology clinical trials (e.g. FIH, SAD/MAD, DDI, QTc, Human ADME, food effect). Operating with broad direction from the Clinical Operations Management, the individual will oversee the daily trial activities to support both the internal project team and the Contract Research Organizations (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 group.
• Identify and mitigate operational risks unique to early-phase studies.
• Establish high standards and goals for Study Management Teams (SMTs) and clearly articulates goals while holding the SMT and direct reports accountable for missed or delayed deliverables.
• Drives key SMT deliverables in line with approved program timeline.
• Provides daily oversight and support of Clinical Operations representatives in leading the SMTs and assigned areas.
• Provides guidance and support to the various SMT members to ensure SMT activities are delivered per the overall clinical operations plan for assigned study(ies).
• Appropriately escalates and resolves issues internally and externally as elevated by the SMT.
• Ensures SMTs are actively and compliantly managing study efforts while adhering to best practices/ SOPs including the development of Operational Playbook and BIMO list.
• Provide input into clinical study documents with a focus on operational feasibility review of intensive sampling schedules, confinement logistics, and crossover study designs (e.g., clinical study protocol, ICF templates, study plans/tools, and site-facing materials such as site budgets, recruitment material, etc).
• Oversee Phase 1 unit, central labs, and specialty vendors.
• Ensures overall adherence to approved study budgets and responsible for review of forecast changes.
• May provide 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.
• Additional duties assigned as needed.

 

Education/Experience Requirements: 

• Bachelor’s degree in life sciences, nursing, pharmacy or related discipline required. Equivalent combination of education and applicable job experience may be considered.
• 8+ years of progressive clinical trial experience including at least 2 years in a leadership role overseeing the execution of clinical trials or programs required.
• Experience in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH E6 (R2) GCP.
• Significant experience leading Phase 1 Clinical Pharmacology studies and healthy volunteer trials.

 

Additional Skills/Experience: 

• The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Ability to adapt to modifications and changes to project plans by demonstrating flexibility an