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Intercept Pharmaceuticals Director, Program Management in New York, New York

Job Descriptions:

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. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in Talent Acquisition will play a pivotal role in preparing the company for the successful launch of OCA’s second indication.

POSITION SUMMARY:

This position will serve as the Program Management lead for one or more of Intercept’s Program Teams, cross-functional teams responsible for implementing the company’s strategy and overseeing global drug development activities for obeticholic acid (OCA) and our pipeline programs.

ESSENTIAL FUNCTIONS:

Program Team:

  • Partner with the Program Leader and program team members to:

  • Develop and implement a comprehensive strategic plan to support Intercept’s corporate objectives

  • Develop plans to enable successful and timely completion of team goals

  • Ensure seamless communication within team, and between team and senior management

  • Facilitate program team meetings:

  • Ensure collaborative and productive team meetings

  • Actively manage team meetings, ensure appropriate topics brought to the team for discussion and decision-making

  • Prepare and distribute team meeting agendas and minutes

  • Identify action items and manage execution in collaboration with the team leader

  • Partner with the core team members and Regulatory Affairs to complete regulatory submissions

  • Partner with the program team, Clinical Development, Commercial, Medical Affairs, Product Development and other key functional areas to develop plans to move program forward

General Project Management and Communication:

  • Coordinate and monitor all project activities in collaboration with the program leader and program team members

  • Ensure team charters, state gate contracts, Go/No Go decision criteria, development plans and other key project documents are prepared and have team agreement

  • Responsible for development and maintenance of project timelines/Gantts; identify potential timeline risks, issues, and deviations from plans

  • Work with senior management and the finance department to track project budgets and resourcing needs; participate in annual budget and forecasts

  • Communicate with program team members to ensure that each team member is aware of both individual and team responsibilities and deliverables and that team members follow through on execution

  • Serve as the central point of contact for all program-related communications

  • Assist program team to effectively communicate across key functional areas, including Clinical Development, Regulatory Affairs, Commercial, Medical Affairs, Finance, etc., including posting regular meeting minutes and hosting cross-functional meetings

Required Experience:

QUALIFICATIONS:

  • BS or BA required, advanced degree strongly preferred

  • Minimum of 10 years of drug development experience is required

  • Minimum of 5 years of project management experience in the biopharmaceutical industry is required

  • PMP certification is desirable

REQUIRED KNOWLEDGE AND ABILITIES:

  • Strong verbal and written communication skills are essential

  • Ability to understand the science of the indication/therapeutic area and the molecule in order to effectively document issues and agreements

  • Strong understanding of drug development processes from strategic and operational perspectives (including regulatory understanding, clinical operations feasibility, etc.)

  • Able to facilitate activities across many disciplines represented on drug development project teams

  • Ability to manage and direct work in a matrix environment; ability to work collaboratively across all levels of the organization

  • Ability to work in a fast-paced environment

  • Excellent organization and multi-tasking skills

  • Strong interpersonal skills and problem-solving capabilities

  • Proven meeting planning and team facilitation skills

  • Able to create, track and plan timelines and budgets

  • Proficient in Microsoft Project, Excel, PowerPoint & Word; Planisware experience desired

  • Occasional travel (up to 15%)

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Keyword: Director, Program Management

From: Intercept Pharmaceuticals

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