Project Manager, Clinical Development Operations
Astellas

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:

The Project Manager executes the identification and implementation of appropriate standards and consistent business processes, platforms, and analytics from relevant systems to facilitate alignment of related activities across DPM with the overall (Development Project Management) DPM and Development strategies; to enable DPM, and key stakeholders both within and outside the Development organization to take appropriate business actions and timely decision making.

Implementation of selected processes and other DPM initiatives in support of organizational efficiency and effectiveness.

Essential Job Responsibilities:

• Displays a global mindset and fosters global optimization of DPM processes and systems.
• Under the direction of the Team Lead, CPME, implements tools and processes to enable DPM's global mission, & vision including the development of standardized PM tools and their application globally.
• Provide expertise to integrate relevant global systems, including reporting and tools across PF/Development Division, collaborating with relevant departments, system owners, and other key stakeholders to progress oversight and planning.
• Provide Primary Focus/Development Division support with asset level contracting requests & ECHO approvals in close collaboration with DPM and other key stakeholders.
• Development and documentation of DPM best practices or further guidance detail of high level policies, SOPs or other guidance documents including drafting, reviewing, posting, distributing, and if necessary conducting roll-out training.
• Manage activities for DPM (e.g., GPML Playbook , Training, Helix support, Monthly Report quality checks, task force support, DPM website/Sharepoint, contract/ECHO support, etc.)
• May be asked to oversee / mentor junior staff or contractors.
• Works globally with CPME and DPM members, oversees assigned task force activities, and works with process specialists within or outside DPM to achieve global functional objectives and deliverables.
• Manages assigned terminated projects through full closeout in Helix and may also be assigned to support components of a larger, more complex 1project under the supervision of a Team Leader and guidance from other project management members.
• Functions within relevant legislation and regulations.

Quantitative Dimensions:

Responsible to identify and implement appropriate systems and processes in DPM. Under supervision of the Team Lead, CPME or delegated mentor, manages the development and execution of assigned CPME activities in support of DPM. Additionally, the Associate Project Manager, CPME may contribute to divisional and corporate initiatives that relate to the drug development processes.

The Associate Project Manager, CPME helps to influence the acceleration of all projects globally. The span of control is approximately 10x larger than at project level. One successful project / year marketed a month sooner equals a month of peak sales, 10-100 okuYen (10-100 millions US dollar).

Organizational Context:

• Reports to the Team Lead, CPME, who in turn reports to the Head, Operational Excellence, DPM.
• Receives matrix leadership from DPM-LT when appropriate.
• Gets assignments from Team Lead, CPME and works with the appropriate stakeholders to optimize the final roll out within agreed boundaries also agreed with the Team Lead, CPME (line manager).