Senior Director, Clinical Data Management

Intercept Pharmaceuticals, Inc. San Diego , CA 92140

Posted 2 days ago

COMPANY SUMMARY:

At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases.

Intercept's lead product, Obeticholic Acid (OCA), is a potent first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name "Ocaliva," is approved in the U.S., EU and Canada for use in primary biliary cholangitis (PBC), a rare autoimmune liver disease. OCA is also being investigated as a treatment for nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).

In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH. REGENERATE is the first and largest Phase 3 study in NASH a chronic disease that threatens the lives of millions of people in the U.S. alone. By 2020, NASH is expected to overtake hepatitis C as the leading cause of liver transplants in the U.S. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.

Based on the positive results from REGENERATE, Intercept intends to file for regulatory approval in the U.S. and EU in the second half of this year. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH.

POSITION SUMMARY:

The Senior Director, Data Management, is responsible for leading the data management functions and coordinating functions related to the planning, execution, collection, and cleaning of clinical data. This position has oversight of activities leading to the final delivery of clean clinical data for the purpose of clinical study reports, publications, and regulatory submissions. In addition, this position has leadership role responsibilities to proactively develop plans for the utilization of EDC system and other clinical data applications that allow for internal control of clinical databases. This position may have direct supervisory responsibilities for internal staff or external consultants. This position will take a leadership role in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC documentation.

ESSENTIAL FUNCTIONS:

To perform this job successfully an individual must be able to perform each essential function satisfactorily.

  • Develop and implement strategic vision for data management (DM) group

  • Responsible for managing, planning and coordinating the activities of the Data Management group

  • Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.

  • Ensure that the Data Management group is aligned with business objectives and complies with FDA requirements.

  • Contribute to development of outsourcing strategies and relationships with outsourcing partner and play a key role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.

  • Manage the clinical data managers within the organization.

  • Work closely with CROs to prepare and ensure proper execution of data management plans; manage data management projects from beginning to end.

  • Work closely with Medical Directors, Medical Monitors, CTAs, and CRAs in planning and execution of DM activities regarding clinical studies.

  • Coordinate with biostatisticians, data managers, CRAs, programmers, etc., to expedite and assure the flow of data between study sites, the data management group.

  • Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.

  • Participate in cross functional team meetings as requested.

  • Coordinate with SAS programmers to create and validate database design and edit check specifications.

  • Communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.

  • Ensure coding of safety data is accurate using industry standard coding conventions.

  • Coordinate the transfer of clinical data between all vendors participating in a clinical study.

  • Oversee interactions with central clinical laboratories on collection, transmittal and transfer of study specific data.

  • Develop and update SOP's associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.

  • Audit potential data management vendors, as appropriate.

  • Assist in design of case report forms (CRFs), DMPs, and CCGs for clinical studies.

  • Provide oversight on quality database design, validation, and deployment to ensure quality and efficiencies through data and process standardization.

  • Take a leadership role in the review and query of clinical data. This includes the critical review of data-populated tables, figures, and listings as part of the database clean-up and prior to database lock.

  • Provide technical direction to facilitate the adoption and use of technologies for DM and trial management.

  • Assure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines.

QUALIFICATIONS:

  • Requires a Bachelor's degree.

  • Minimum of 10 years' experience in a clinical research data handling environment with relevant practical experience in protocol review/CRF design, clinical study databases and data management and at least 2 years' experience managing others.

  • Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.

  • Experience with SAS.

  • Excellent time management, ability to coordinate workload and meet established deadlines.

REQUIRED KNOWLEDGE AND ABILITIES:

  • Minimum of 10 years' experience in a clinical research data handling environment with relevant practical experience in protocol review/CRF design, clinical study databases and data management and at least 2 years' experience managing others.

  • Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.

  • Experience with SAS.

  • Excellent time management, ability to coordinate workload and meet established deadlines.

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Senior Director, Clinical Data Management

Intercept Pharmaceuticals, Inc.