Associate Director, Clinical Operations in San Diego, CA

$100K - $150K(Ladders Estimates)

Retrophin   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 74 days ago

This job is no longer available.

Job Summary:

Retrophin 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).

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.

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.

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.

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.

· Actively and effectively communicates within Clinical Operations and R&D regarding the developments, progress, activities and results for assigned responsibilities.

· With support from senior management, appropriately escalates and resolves vendor issues as necessary.

· Prepares and delivers status updates to senior management as needed. Supports CTMs by reviewing study status reports and updates, providing guidance 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.

· In conjunction with the CRO, tracks study status, timelines, enrollment, regulatory documentation, and site start‐up status for assigned clinical trials.

· Forecast trial resource needs (external costs); accountable for the trial level clinical operations budget, management and tracking of trial budget in conjunction with CRO and contract manager.

· Provides direct line management and active coaching and mentoring to junior staff in the department.

· Exhibits leadership behaviors by setting high standards and goals for one's self and direct reports.

· Review and approves site budgets, manage clinical trial budgets, collaborate with finance to provide input into financial reporting and financial projections. Collaborate with other functional groups including Regulatory, Data Management, Pharmacovigilance and others to ensure alignment on operational plans for assigned studies or program. Communicate key issues and mitigations to relevant cross-functional stakeholders.

· Actively participates as a member of the study team to move the team forward toward the completion of goals. May be assigned studies to actively manage.

· Familiar with global regulatory and compliance requirements for clinical research including but not limited to UD 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.

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 8 years of clinical operations experience in a pharmaceutical or CRO setting, including at least 2 years on a leadership role overseeing the execution of clinical trials or programs.

· Ability to actively managed phase I, II and III studies and served as a clinical operations lead for multiple studies or within a program, or closely relevant experience is preferred.

· Global trial management experience preferred.

· Previous line management and personnel development experience required.

· 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.

· Ability to travel 10%-20%

Valid Through: 2019-9-3