Tuesday, December 16, 2014

Director - Project Management - Commercial - Intercept Pharmaceuticals - New York


Job description
POSITION SUMMARY:
Responsible for multidisciplinary launch of companies first Commercial product/indication.
ESSENTIAL FUNCTIONS:
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
Leadership of Multidisciplinary Launch Team
Leads Project Team for late stage including all affected disciplines
Developing integrated project plans, timelines, resource and budget models
Creates communication tools and platforms for providing timely updates on overall project progress, identifying risks, delays and activities requiring management attention
Coordinates and manages document review and comments both internal and with contract organizations
Multidisciplinary Launch Team includes representatives from: Commercial, Regulatory, Operations, Development, Manufacturing, Legal, Finance, Compliance, Clinical, and external consultants.

Facilitates strategic planning, meeting and project planning between commercial and development/manufacturing functions to ensure product target profile requirements are fulfilled and any changes are efficiently communicated and addressed.
Proactively identifies potential bottlenecks in commercial plan fulfillment and actively facilitates interventions to reduce or eliminate before they become problems.
Provides technical assessment of project progress.
Performs day-to-day activities of project management including conducting cross-functional team meetings, providing meeting minutes, updating project plans, schedules and timelines, providing progress reports and tracking payments.
Provides input into strategic planning, critical path issues/solutions, resource management and project management.
Ensures that electronic documentation regarding project progress is maintained in the form of technical reports, meeting minutes and current timelines.
Monitors project expenses against budget and works with management and project teams to identify risks, contingencies and alternatives.
Motivates contract organizations to achieve goals on time, within budget and to expected quality criteria.
Establishes clear channels of communication with remote team members and contract organizations.
Other duties as assigned.

Desired Skills and Experience
QUALIFICATIONS:
Requires a Bachelor’s degree, MBA or other advanced degree preferred.
PMP certification preferred.
Minimum of 5 years’ experience in biopharmaceutical or biotechnology commercial project management.
Product launch experience needed including coordinating activities associated with project licensure and launch as well as familiarity with supply chain requirements including packaging and labeling.
Biopharmaceutical / pharmaceutical expertise including demonstrated ability to manage multi-functional projects and have understanding of biopharmaceutical programs including CMC, Clinical, Regulatory, Quality and Commercial systems.
Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions.
Proven ability to manage project teams remotely. Must be able to travel up to 25%.
Must maintain comprehensive proficiencies with Microsoft Project, Microsoft Office (including Word, Excel and PowerPoint) and associated applications.

REQUIRED KNOWLEDGE AND ABILITIES:
Strong verbal and written communication skills are essential.
Excellent organization and multi-tasking skills.
Exceptional interpersonal skills and problem solving capabilities.
Proven meeting planning skills.
Ability to work effectively across a matrix organization.
Ability to work independently and prioritize with minimal daily instruction.
Ability to think strategically in order to improve current processes.
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