Senior Director, Clinical Data Management

Intercept Pharmaceuticals, Inc. San Diego , CA 92140

Posted 3 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.

#LI-JJ1


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Director Commercial Clinical Diagnostics (UsRemote)

Thermo Fisher Scientific Inc.

Posted 3 days ago

VIEW JOBS 11/14/2019 12:00:00 AM 2020-02-12T00:00 Job ID : 102140BR Location : US - California - San Diego|US - California - San Francisco|US - Illinois - Chicago|US - Massachusetts - Boston|US - New York - New York : Job Description LOCATION/DIVISION SUMMARY US REMOTE: CA would be a preferred location The Clinical Diagnostics Division (CDD) is an organization made up of business units which develop, manufacture and market instruments and consumables that serve a broad, diverse mix of diagnostic segments. The major business units include Niche Diagnostics, Biomarkers, Clinical Diagnostic Systems (includes clinical mass spectrometry), and Clinical Diagnostic Reagents. The division manages a diverse portfolio of products servicing multiple end markets. How will you make an impact? The Senior Director, Commercial will have responsibility to meet the Global Sales & Marketing goals as follows: * Develop and execute a strategic and tactical sales plan for Region US / Canada to ensure revenue objectives are met by using company defined financial models. * To manage the distributor relationship within the Us & Canada through management of the in country-based staff. * Management of the domestic sales organization, providing adequate customer and technical support to existing and new customers. The role will also further cultivate and develop a sound direct sales organization with productive sales activities to assure a healthy annual growth rate and in collaboration with Marketing design and develop marketing programs to promote corporate image and benefit the sales effort in collaboration with the BUs. * Identify new business or product opportunities to expand and diversify the company's business portfolio. * Ensure accurate and speedy customer and technical support to all existing customers to solidify our customer base. * Prepare workable annual sales forecast to benefit the operation and corporate resource planning. * Provide research and analysis of business opportunities and assessing potential markets to make recommendations for projects to be used for strategic marketing and sales decisions. * Maintain relationships with leading researchers in the field as consultants, analyze new market areas and determine the financial viability of projects as well as plan a market strategy. * Maintain company activities in compliance with Quality System Regulations (cGMP), ISO 9001, ISO 13485 and CMDR Regulations. * Work to drive product sales to support distributor partnerships and actively promote core products and value-added services * Help Field based Sales Managers identify and satisfy customer requirements and meet the needs of valued business opportunities * Working closely with the Global Marketing organization, including translation of STRAP plans and execution of marketing plans and product launch * Manage MBR and QBR processes providing necessary forecasts and collecting financial updates from the business units * Review, maintain and manage compliance to key performance indicators. To include, but not limited to, sales performance, call planning, call rate and opportunity management and follow up * Leading change and set the right organization to best match the market and to meet the objectives of the strategic plans. * Work closely with the GM's in the Business Units and the Divisional Commercial leads to drive the execution of strategy and tactics to achieve the business objectives How will you get here? Education * Education - bachelor's degree required. Background BS or an MBA with a minimum of 10 years of proven IVD sales and marketing experience in DOA/DAT and/or TDM is preferred. * Minimum 10 years of relevant industry experience, with a proven track record of leading field service and support in In Vitro Diagnostics (preferred), Life Sciences or Medical Device markets, capital sales, distribution management and from matrixed organizations. * Must also be knowledgeable of Solution Selling, Clinical Chemistry, Toxicology. * Must have strong verbal and written communication, as well as contract negotiation skills. * Experience in turnarounds and change management * Excellent Leadership skills, with proven ability to develop a high-performance, customer focused and responsive organization and to get things done through others. * Strong business acumen and use of business analytics to prioritize, lead and influence. * A process improvement mindset and ability to influence and drive change, directly and in a matrixed environment * Ability to effectively lead a commercial team across different geographic regions to ensure consistent process and standards and sharing of best practices in selling. * Ability to effectively network and collaborate with peers in other functions and with colleagues in other businesses. * Excellent ability to develop strategies based on sound analysis and business judgment and to effectively articulate recommendations. * Must have marketing experience * Must be visionary, strategic and tactical * The position requires frequent travel within the US and to internal sites (50 - 75%) At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today! http://jobs.thermofisher.com If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Thermo Fisher Scientific Inc. San Diego CA

Senior Director, Clinical Data Management

Intercept Pharmaceuticals, Inc.