Pharmaceutical Project Management

  Apply  

Irfa******

  • United States 
  • Last Update: 10.05.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Indianapolis, IN, US
Country
United States

Category


Research Positions

Description


Job description

Responsibilities Purpose of Job
  • Independently lead the implementation of a global integrated drug development strategy for a simple to moderately complex asset (simple to moderately complex asset is defined as a molecule in discovery to end of phase 1, end of life cycle or post initial single indication/line extension) or a significant leadership role driving submission planning/preparation, approval and launch and/or a significant PM leadership role on a highly complex asset.
  • Translate marketing, medical, manufacturing and regulatory needs for the molecule/new indication/line extension into a single global integrated development plan.
  • Responsible for delivery of global integrated development plan deliverables in alignment with the global asset strategy (including oversight and tracking of direct and indirect resourcing).
  • Responsible for quality and organizational excellence of the assigned team, including performance of cross-functional/corporate processes, alliance management, affiliate relationships and team culture.
  • Lead the application and integration of key project management processes and tools across teams and/or subsets of teams to deliver asset and portfolio value with quality on time, on budget and within scope.
  • Effectively manage upward and cross-functional communication, anticipate and resolve issues with the team, asset and portfolio in mind, ensure documentation of key team/asset information and decisions, and ensure project management systems are up to date
Core Job Tasks Enable Strategy (10%)
  • Lead the core team through the development of the asset strategy, leveraging quality decision making principles.
  • Ensure alignment of asset strategy with the approved cope (indications, resources, etc.).
  • Lead the alignment between asset strategy and implementation.
  • Utilize the change management process to manage scope
Integrated Plan Development (25%)
  • Lead creation of a global integrated cross-functional development plan that articulates the strategy for the asset and provides the foundation for operational objectives.
  • Develop and manage the service level agreements between BUs and MDU.
  • Provide or drive immediate and accurate communication of key decisions/results that have team, asset, and/or organizational impact. Work with corporate affairs and investor relations to manage communication about the asset outside of the company.
  • Portfolio Alignment: Lead delivery of a plan that is in alignment with corporate priorities and the approved asset scope.
  • Cost Management: Drive development of a global integrated development project budget that aligns team, functional, and geographic resources (direct and indirect spend
  • Obtain required governance approvals for the molecule/indication plan
Deliver Results (40%)
  • Accountable for delivery of project milestones with quality on time, on budget, and within scope.
  • Lead the team to meet or exceed overall project goals (completion of clinical studies, submission and approval timing, publications, etc.).
  • Ensure that cost, timeline, scope, and risk management processes are in place on the team to monitor and control performance of the overall development project that utilizes appropriate tools and techniques (SAP, Orion, PCE, Critical Chain, Budget Monitor and Control, Risk Tool, etc.).
  • Lead the PM teams with judgment-based decisions.
  • Adapt quickly to change and assists others in aligning with the changes.
  • Monitor and prioritize risk with the team and communicate status of potential risk to governance, the business unit and senior leadership as appropriate.
  • Suggest ways to avoid/mitigate risk and initiate contingency plans as needed.
  • Hold functions accountable for achievement of key development project deliverables in alignment with the agreed to project plan and in compliance with corporate quality standards.
  • Demonstrate independent problem solving.
  • Deliver cross-functional results through people utilizing influence rather than direct or positional authority and reaching across boundaries.

Get In Touch