Senior Director, Clinical Operations

Travere Therapeutics; San Diego (CA); On-site; USD 219,000 - 285,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is looking for a Senior Director of Clinical Operations in San Diego, California. This role is responsible for overseeing clinical trial management for investigational trials, coordinating activities, and managing the Clinical Trial Managers to ensure successful implementation and execution of trials.

The ideal candidate will have at least 12 years of clinical operations experience, including leadership roles, with strong communication and analytical skills. The position includes a competitive compensation package and comprehensive benefits.

Qualifications

• Minimum 12 years of clinical operations experience in a pharmaceutical or CRO setting.
• At least 6 years in a leadership role overseeing execution of clinical trials.
• Experience managing Phase I, II, and III studies.

Responsibilities

• Oversee clinical trial management for multiple investigational trials.
• Manage CTM function and ensure timelines/key deliverables are met.
• Guide cross-functional groups to ensure alignment on operational plans.

Skills

Leadership

Clinical trial management

Communication skills

Analytical thinking

Interpersonal skills

Education

Bachelor's degree in a life science

Job description

Position Summary

The Senior Director, Clinical Operations is responsible for overseeing clinical trial management for several investigational trials within a development program. The individual will coordinate, track, and manage daily activities for one or multiple clinical studies led by Clinical Trial Managers (CTMs) providing oversight to both the internal project team and the CRO(s).

Responsibilities

• Manage and provide daily oversight of the CTM function in the day-to-day management and study oversight of full service CROs and third-party vendors to ensure successful clinical trial implementation and execution.
• Ensure timelines/key deliverables (e.g. study recruitment, DBL) are on track and is accountable for assigned studies and on‑time delivery of study milestones. Implements mitigations as required.
• As member of Clinical Operations Leadership Team (COLT) help provide strategic direction on departmental and company initiatives.
• Clearly articulate goals and hold Study Management Team (SMT) and direct reports accountable for missed/delayed deliverables.
• Guide other functional groups including Regulatory, Data Management, Biostatistics, Pharmacovigilance, and others to ensure alignment on operational plans for assigned studies or program. Communicate key issues and mitigations to relevant cross‑functional stakeholders.
• Review and approve site budgets, ensure overall adherence to approved study budgets, collaborate with finance to provide input into financial reporting and financial projections. Forecast trial resource needs (external costs); responsible for review of forecast changes, management and tracking of trial budget in conjunction with CRO and contract manager.
• Appropriately elevate vendor, internal and external issues as necessary and resolve issues as needed.
• Demonstrate excellent communication skills, both oral and written, and confidently develop materials and present to senior leadership (DRC, ET, PGT and BoD as applicable) while communicating key issues and mitigations to relevant stakeholders.
• Prepare and deliver status updates to senior management as needed.
• Manage and communicate study status updates to senior management including overall clinical operations plan for investigational trials, timelines, internal and external resources/costs, and critical deliverables.
• Ensure SMT(s) actively and compliantly manage study efforts while adhering to best practices/SOPs including the development of an Operational Playbook & BIMO list.
• In conjunction with the CRO, track study status, timelines, enrollment, regulatory documentation, and site start‑up status for assigned clinical trials.
• Monitor resource allocation to ensure adequate staff for required work and assist in planning for future resource needs.
• Provide direct line management and active coaching and mentoring to junior staff in the department and provide oversight and support of CO representatives in leading the SMTs and assigned areas.
• Guide and support SMT members to ensure SMT activities are delivered per the overall clinical operations plan for assigned study(s).
• Exhibit leadership behaviors by setting high standards and goals for oneself and direct reports.
• Provide oversight review of study protocol, ICFs, and study plans.

Education and Experience Requirements

• Bachelor's degree, or equivalent, in a life science or related field of study. Equivalent combination of education and applicable job experience may be considered.
• Minimum of 12 years of clinical operations experience in a pharmaceutical or CRO setting, including at least 6 years in a leadership role overseeing the execution of clinical trials or programs.
• Has actively managed Phase I, II, and III studies and served as a clinical operations lead for multiple studies or within a program, or closely related experience is preferred.
• Global trial management experience preferred.

Additional Skills and Experience

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus, and Teamwork.
• Experience in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
• Proactive, self‑starter who possesses exceptional multi‑tasking and communication skills, both oral and written.
• Ability to continually evaluate a variety of unpredictable scenarios and achieve program timelines while applying an understanding of the overall program strategy.
• Advanced analytical thinking to quickly triage multiple solutions to an issue, determine the best path forward, and apply solutions across multiple studies within a program as needed.
• Ability to provide input into overall clinical strategy and potentially other workstreams where clinical feedback is required.
• Strong sense of urgency, keen attention to detail, ability to work independently, and effectively manage multiple priorities in an environment under time and resource pressures.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills required.
• Successful record of creating and managing complex project plans, timelines, budgets, and critical paths.
• Ability to adapt to modifications and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Ability to identify and plan for potential risks and implement mitigation strategies as needed.
• Preferred previous line management experience with the ability to effectively manage performance, engage team members, provide coaching, and respond to situations affecting staff.
• Ability to travel 10–20% domestically and internationally.

Benefits

Our benefits include premium health, financial, work‑life and well‑being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match, and generous paid time off.

Compensation

Our competitive compensation package includes a combination of both cash compensation (base pay and short‑term incentive) and long‑term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range: $219,000.00 – $285,000.00

* This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

EEO Statement

Travere is an EEO/AA/Veteran/Disability Employer.

Accommodation Statement

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.