Astellas Pharma Associate Project Management Director in Northbrook, Illinois

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing Associate Project Director opportunity in Northbrook, IL.

Purpose & Scope:

  • Executes project management for multiple priority projects within a specific (set of) Therapeutic Area ('s). Within the assigned therapeutic area(s), serves as the GPML, RPM and/or LPL1 and as a key member of the Global Project (Core) Team (GPT; Core Team, CT) to monitor and direct project planning, deliverables, budget, resources, as well as risk assessment and management for assigned projects across all phases of global development (I - IV), projects. Assigned projects can have wide ranging complexity2 including activities related to chemical/pharmaceutical, pre-clinical, and clinical development as well as regional drug development, registration, in-licensing and project life-cycle management (LCM).
  • Ensures integrated functioning within the Global Project Management (GPM) department; responsible for building and sustaining collaborative relationships with internal and external Astellas stakeholders including Global Development Project Leader (GDPL), GD Core Team members, Marketing, Medical Affairs and Business Development.

Essential Job Responsibilities:

Strategic Aspects of Project Management

  • Routinely assesses and manages risk; leads and designs contingency plans with assistance from team.
  • Analyzes the impact of portfolio decisions on projects, programs and therapeutic areas.
  • Assists in developing and establishing strategies for portfolio and project team with GDPL and Therapeutic Area Heads.

Project Management:

  • Executes project management processes to support drug development (pharmaceutical, pre- clinical and clinical), registration, marketing, LCM, and in-licensing for an assigned set of projects of wide ranging complexity and assigned therapeutic area(s).
  • Collaborates with the GDPL, GPML and/or RPM(s) to implement the CMC, Research and Portfolio Strategy Group activities within the Global Master Plan and provides project management leadership on regional project management processes, identified critical path steps, ensures execution of critical path activities, and seeks optimization of development timelines.
  • Prepares the CT minutes, manages the logistics of critical path work plans essential to execute the Global Development Strategy ensuring efficient development from P0 stage, i.e., initiating the preparation for First in Man, through registration.
  • Reviews and compiles development plans at key milestones, identifying project risks and facilitating resolution of issues, and assesses the impact of external environment (e.g., regulatory) on tasks for Astellas.
  • Monitors the assigned project development processes, recognizing the key variables and analyzing complex situations. Takes proactive action to manage risk and improve efficiency. Proactively reports progress to the GDPL, GPML and/or RPM(s). This involves all logistics and analyses of critical-path work plans essential to optimizing development time towards the registration and launch of new products.
  • Assures that adequate resources are allocated to the assigned project teams to execute the development plan. Proactively identifies and monitors quality control measurements for project management processes.
  • Contributes to a high performance team spirit and to Core Team confidence, ensuring strategic, clear and transparent communication towards high quality data and minimizes potential delays in development.
  • An RPM assigned in the third region (non-TA region) supports late-Phase US/EU-driven project activities at the assigned region in close collaboration with GPML and/or RPM(s).
  • As a Local Project Leader (LPL), for assigned products, acts as an GD liaison to collaborate with the Franchise Brand Director (of the Life Cycle Management Core Team) from Commercial in order to facilitate Phase IIIb/IV development and SmPC variations worked on at Commercial (APEL in the EU) or developing new GD projects (including in- licensed co-development projects and local projects such as line extensions and new formulation development, organizing requested support, whether from Regulatory Affairs, Global Development Operations, CMC, or Medical Science).
  • Responsible for the tactical (translating strategy into action) project management activities of projects as defined by the LCM Core Team (where applicable), involving planning of project budget, resources and deliverables as well as risk management. Maintains appropriate contact with Medical Affairs, Business Development and Marketing in order to ensure effective and timely communication between commercial and GD.
  • Collaborates proactively with GDPL, TA-Head, and Core Team in identifying reasonable budgetary, scope and time related constraints for the overall program. Effectively communicates constraints in the Core Team, related Extended Teams and functional heads in a timely manner.

Functional:

  • Ensures integrated functioning within GD project management and within the Global Project Management (GPM) department; responsible for building and sustaining collaborative relationships with internal and external Astellas stakeholders including Global Project Management Lead (GPML), Global Development Project Leader (GDPL), Regional Project Manager (RPM), Core Team leads, Marketing, Medical Affairs and Business Development.
  • Partners with the Team Leader and departmental members to problem-solve, leading to optimization of departmental processes for the regional and global project management department. Ensures execution and adoption of GPM practices within and across assigned projects.
  • Ensures personal compliance with regional and global policies, SOPs and Code of Business Conduct of regional and global Astellas Pharma, GD, as well as relevant legislation and regulations.
  • Proactively identifies improvement areas for existing processes to problem-solve and propose efficiencies for implementation and solutions for processes and/or organizational structures and policies.
  • Participates in the training and supervision of Associate PMs, PMs, and Senior PMs assigned to his/her projects, as applicable.

Quantitative Dimensions:

  • Manages and coordinates activities in Core Teams consisting of 5-8 individual functional experts.
  • In round figures, 2010 Sales in Astellas amounted to approximately 10 billion Euro. Astellas spends approximately 20% in R&D; 2% of annual sales is drug development budget in the US, 2% in Europe; a smaller part is spent by Astellas' commercial departments in Phase IIIb / IV and life cycle management. Project managers in GPM are responsible for approximately 5-10% of the project management functions (GPML, RPM, LPL) within the regional GD and LCM Core Teams for those projects, managing therefore expenditure of approximately 0.1- 0.2% of global annual sales. Typically, Phase 1 projects require a budget of several millions of dollars, Phase 2 projects require 10-fold and Phase 3 projects require up to 100 fold, spread over a number of years, and depending on the Therapeutic area.

Organizational Context:

The Associate Project Director reports into the Team Leader (Director), Project Management and does not have any direct line management responsibility. The Associate Project Director may indirectly oversee and/or supervise the work of Project Assistants, Associate Project Managers, Project Managers or Senior Project Managers assigned to support his/her projects, as applicable. A Project Management Associate may be added to Teams, primarily to support the Team Leader; supports Team Members where the TL deems appropriate.

Qualifications:

Required

Education and Experience

Bachelor

Master (a plus)

7+ yrs Pharmaceutical R&D

5+ yrs Pharmaceutical R&D

3+ yrs international DD process

3+ yrs International DD process

  • Demonstrated excellence in communication, negotiation/influencing, people management and social skills with a good sense of diplomacy both in a scientific, industrial and commercial environment, both relating to peers and higher management.
  • Active and passive skills in English, leading and attending meetings, presenting and training.
  • Language skills in Dutch and/or Japanese are an advantage.
  • Committed to continued self-development, growth and demonstrated flexibility in accepting complicated projects.
  • Proven leadership and team management skills in a matrix organization with a successful track record of accomplishing high quality results through project and departmental team level performance.
  • Capable of making quick assessments, using good judgment in taking swift corrective action and appropriate decision making.
  • A key organizer with demonstrated prioritization of developmental activities; finances with experience in financial reporting and planning systems/processes.
  • Manages projects for external development partnerships/alliances and works with Partner PM functions as appropriate.
  • In-depth knowledge of the global drug development process, including proven history of multidisciplinary global program management experience across multiple phases and ranges of complexity including programs which involve co-development and in-licensing partnerships, etc.
  • Has proven experience in at least one IND/CTX, NDA/CTD, Advisory Committee or other major FDA / EMA / PMDA submission and/or meeting; hands-on experience with successful drug registration is an advantage.
  • Scientific academic background supportive of acquiring knowledge of Astellas' projects and products within the assigned therapeutic area(s).
  • Understanding the implementation and impact of regulatory requirements and guidance /internal SOPs / PM concepts.
  • Experience with co-licensing development desired.
  • Effective leadership under pressure, consistent team player, reliably accurate and patient.
  • Proficient in using relevant software, adept at using Astellas systems. Easily adapts to change.
  • Able to travel internationally, across time zones.

*LI-VB

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Commercial Operations