Associate Director, Clinical Operations

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 articulate goals while holding the SMT and direct reports accountable for missed or delayed deliverables.
• Drive key SMT deliverables in line with approved program timeline.
• Provide daily oversight and support of Clinical Operations representatives in leading the SMTs and assigned areas.
• Provide 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 escalate and resolve issues internally and externally as elevated by the SMT.
• Ensure 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.
• Ensure 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 and urgency to implement new strategies and tactics to accommodate these changes.
• Excellent communication skills, both oral and written and is confident in developing materials and presenting to senior leadership (as applicable).
• Ability to think analytically to quickly triage multiple solutions to an issue and determine best path forward.
• Strong skills in MS Office and timeline software such as MS Project or Smartsheet.
• Experience with clinical systems such as IRT, eTMF, etc.
• Successful record of creating and managing complex project plans, timelines, budgets, and critical paths.
• Highly organized and can deliver upon the overall clinical operations plan for assigned study(ies).
• Demonstrates excellent understanding of cross functional activities and input into clinical studies.
• Previous line management experience with the ability to effectively manage performance, engage team members, provide coaching, and respond to situations affecting staff preferred.
• Ability to travel 10-20% domestic and internationally.