Director, Data Management

Retrophin San Diego, CA
Job Title: Director, Data Management

Department: Biometrics;Research and Development

Reports to: ExecutiveDirector, Biometrics

Office Location: SanDiego

PositionSummary

Retrophin, Inc. is a biopharmaceutical company focused ondiscovering, developing, and marketing innovative therapies for debilitatingand often life-threatening diseases. Wehave ongoing development programs for Focal Segmental Glomerular Sclerosis(FSGS), Pantothenate Kinase-Associated Neurodegeneration (PKAN), andothers. The clinical trials associated with these development programswill be performed on a global scale in coordination with Contract Research Organizations(CROs). These trials are planned to be submitted to health careregulatory authorities around the world such as the United States Food and DrugAdministration (FDA) and the European Medicines Agency (EMA).

We are seeking a leader to head the DM team in overseeing severalongoing trials, starting-up new trials and providing DM vendor oversight activitiesacross the development programs. The incumbent will work closely with thehead of Biometrics in identifying project DM demands and resource needs.Provides hands-on support to project teams by leading data management efforts,and coordinating with external vendors, data managers, and other businessfunctions to ensure timely and quality delivery of data management deliverablesfor clinical projects. Contributes tothe overall efficiency and best practice running of the Biometrics group,demonstrating the ability to work efficiently and to a high standard within a cross-functionalteam environment. Strong technicalskills and experiences supporting regulatory submissions are required.

Essential Responsibilities:

* Provide strategic inputto and leadership of data management contributions across all clinicaldevelopment projects.

* Provide oversight of multipleprograms, including timelines, resources and budgets. Ensure that budgets and timelines are adhered to (eg, DB go live,data base locks, etc.).

* Manage and provide oversight of CROsand third-party providers to ensure successful clinical trial implementationand execution.

* Ensure data quality by reviewing, query writing, identifying protocoldeviations, as well as coding.

* Lead or contribute tothe development and review of case report forms, database specifications, and validationplans and supportive documentations, including UAT.

* Develop and maintain datamanagement-related SOPs, work practice documents, technical standards, and dataspecification documents.

* Identify and lead theapplication of data management approaches to support all aspects of theclinical development process. Leverage tools to collect and manage data toenable decision making. Identify the need for and lead the development andmaintenance of applications used for data collection and management.

* Manage data managers andcontribute to the professional development of Biometrics personnel byconducting trainings and coaching.

Requirements:

* Bachelor degree in life science, pharmacy or related discipline. Masters preferred.

* Minimum of 10 yearsof experience in Data Management. Lead DM experience is required.

* Strong understanding of datamanagement and clinical related issues along with an ability to demonstratesignificant leadership of technical activities (eg, database development,cross-system integration, etc.) in a clinical pharmaceutical/CRO environment.

* Experience in allstudy phases, from study start-up to submission. Registry experience a plus.

* Demonstrated experiencewith managing vendors or direct reports and success at leading teams.

* Knowledge of drugdevelopment process.

* Understanding ofICH Guidelines and GCP Requirements as they pertain to data management.

* Well-versed indifferent EDC Systems.

* Ability todevelop and maintain timelines.

* Experience in managingseveral programs.

* Excellentcommunication skills and interpersonal skills.

* Travel 10-20%

Retrophin,Inc. is an EEO/AA/Veteran/Disability Employer