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), 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).
This position is responsible for overseeing clinical operations/clinical trial management for Phase 2, 3 or 4 studies either within or across development programs. Under the guidance of Clinical management, the individual will coordinate, track, and manage daily activities for multiple clinical trials to support both the internal project team and the CROs.
At Retrophin, our mission is to identify, develop and deliver life-changing therapies to people living with rare diseases to help them achieve the best possible therapeutic outcomes. Giving patients a chance, providing hope, is what drives us.
Retrophin recognizes that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of patients. Our work is rewarding, professionally and personally because we are making a difference and we are passionate about what we do.
We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast paced environment and share in our mission to help others. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland.
· Manage and provide daily oversight of full service CROs and third party vendors to ensure successful clinical trial implementation and execution.
· Manages and communicates to senior management overall clinical operations plan for clinical trials including timelines, internal and external resources/costs, and critical deliverables.
· Manage trial execution to deliver on established timelines for study start-up, enrollment targets, data delivery and study closure milestones for assigned clinical trials.
· Review and approve site budgets, manage clinical trial budgets, collaborate with finance to provide input into financial reporting and projections.
· Ability to lead cross-functional teams including Data Management, Pharmacovigilance and others to ensure precise review of the clinical trial data. Communicate key issues and mitigations to relevant cross-functional stakeholders.
· 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. Advanced degree is preferred.
· Minimum of six (6) years or more of clinical operations experience in a pharmaceutical or CRO setting, including a minimum of 1 year of clinical trial leadership.
· 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 be able to effectively manage multiple priorities in an environment under time and resource pressures.
· Previous CRA monitoring experience preferred.
· Ability to travel 10% to 20% domestic and internationally.