Astellas Pharma Associate Project Director, Drug Development, Global Project Management in Northbrook, Illinois
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and 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, RPR and/or LPL 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 projects. Assigned projects can have wide ranging complexity 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 Development Project Management (DPM) 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.
As a Local Project Leader (LPL) for assigned projects, be an accountable project owner for Japan/Asia local projects in the same manner as a Global Development Project Leader (GDPL) for global projects. Leads and chairs a local project team, maintaining a strategic focus and ensuring success in meeting the team's commitment to Development leadership.
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.
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 RPR(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.
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 RPR(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 RPR supports project activities at the assigned region in close collaboration with GPML and/or RPR(s).
As a Local Project Leader (LPL), for assigned products, provides leadership in accordance with the local/global therapeutic area strategy, established timelines/milestones and in accordance with all applicable regulatory standards. In case of co-development or in-licensed projects, LPL is fully accountable for the collaboration and decision making with the partner companies as the representative of Astellas. Provides input and leadership in development of budgets, resource estimations and allocation. Requires ability to prioritize deliverables relative to the project plan, ability to resolve conflicts amongst/between team members vs. escalations to management as first action.
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 Development.
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.
Ensures integrated functioning within the Development Project Management (DPM); 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 (RPR), 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 DPM 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, Development, 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.
Manages and coordinates activities in Core Teams. Responsible for approximately 2 to 10 projects including local and global projects across multiple phases with budgets totaling approximately 10-200 oku-yen (approx., 10-200 million USD).
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.
Bachelor's Degree required; Master's degree preferred
5-7 years of previous Pharmaceutical R&D experience
3+ years of international drug development experience
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.
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.
Has proven experience in at least one IND/CTN, NDA/CTD, Advisory Committee or other major FDA / EMA / PMDA submission and/or meeting; hands-on experience with successful drug registration is an advantage.
Active and passive skills in English, leading and attending meetings, presenting and training.
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.
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 guidances / 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.
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Development Project Management
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans