This position is responsible for overseeing clinical operations/clinical trial management for several investigational trials within a development program, or programs. Under the guidance of Research & Development (R&D), the individual will coordinate, track, and manage daily activities for multiple clinical studies led by Clinical Trial Managers (CTMs)to support both the internal project team and the CROs.
Retrophin, Inc. is a biopharmaceutical company focused on discovering, developing, and marketing innovative therapies for debilitating and often life-threatening diseases. We have ongoing development programs for Focal Segmental Glomerular Sclerosis (FSGS), IgA nephropathy (IgAN), Pantothenate Kinase-Associated Neurodegeneration (PKAN), and others. The clinical trials associated with these development programs will be performed on a global scale in coordination with Contract Research Organizations (CROs). These trials will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
- Manages and provides 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.
- Pro-actively and effectively communicates within Clinical Operations and R&D regarding the developments, progress, activities and results for assigned responsibilities.
- Provides critical input to protocol development or development of the clinical program.
- Ability to independently manage vendors and third-party providers. Ability to effectively resolve issues escalated from the project teams.
- Pro-actively identifies and mitigates key cross-functional and vendor issues independently with limited need to escalate.
- Prepares and delivers status updates to senior management and executive management as needed.
- Supports CTMs by reviewing study status reports and updates, provides guidance and feedback as needed.
- Manages and communicates to senior management overall clinical operations plan for investigational trials including timelines, internal and external resources/costs, and critical deliverables.
- Ensures that CTMs and Clinical Operations Associates (COAs) are actively managing assigned study efforts, are adhering to best practices and established work procedures.
- Provides strategic oversight to ensure deliverables are tracked for all associated study vendors.
- In conjunction with the CRO, tracks study status, timelines, enrollment, regulatory documentation, and site start?up status for assigned clinical trials.
- Forecasts trial resource needs (external costs); accountable for the program level clinical operations budget, management and tracking of trial budget in conjunction with CRO and contract manager.
- Provides direct line management for direct reports including active coaching and mentoring to staff in the department and cross-functionally as needed.
- Exhibits leadership behaviors by setting high standards and goals for one’s self and direct reports.
- Reviews and approves site budgets, manages clinical trial budgets, collaborates with finance to provide input into financial reporting and financial projections.
- Experience in leading a cross-functional team including Regulatory, Data Management, Pharmacovigilance and others to ensure alignment on operational plans for assigned studies or program. Pro-actively identifies and mitigates key issues independently with limited need to escalate.
- Contributes to the development of the Clinical Operations function by initiating and driving positive change with the oversight of new initiatives, systems or directives for ongoing process improvement and implementation of best practices.
- Collaborates with others on strategic vendor selection plans that are optimal for a study or program. Able to liase with other functions on vendor vetting, selection and onboarding plans.
- Reviews and approves vendor proposals and service descriptions and provides recommendations for contract awards.
- Actively participates as a member of the study team to move the team forward toward the completion of goals. Familiar with global regulatory and compliance requirements for clinical research including but not limited to UD CFR, EU CTD, and ICH GCP.
- Bachelor’s degree, or equivalent, in a life science, or related field of study.
- Minimum of 12 years of clinical operations experience in a pharmaceutical or CRO setting, including at least 3 years in a leadership role overseeing the successful execution of clinical trials or programs.
- Experience actively managing phase I, II and III studies and has served as a clinical operations lead for multiple studies or within a program, or closely relevant experience is preferred.
- Global trial management experience required.
- Previous line management and personnel development experience with the ability to independently identify and establish personnel development plans and skill development plans.
- Expertise 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.
- Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and collaboratively, and ability to effectively manage multiple priorities in an environment under time and resource pressures.
- Ability to travel 10-20%.
Requisition ID : 1236