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 a Director, Development Project Management opportunity in Northbrook, IL.
Purpose & Scope:
Development and maintenance of excellence in strategic planning and project management oversight of all development activities in and outside Development allocated to the group, as well as project management methodologies, tools, and competencies.
Execution of project management for assigned projects as GPML, RPR and/or LPL.
Successful application of project management expertise to all phases of drug development, including chemical/pharmaceutical, preclinical, and clinical development phases, and may support regional drug development, registration, marketing, in-licensing and project life- cycle management.
Leadership for a sub-team (Team) of project management professionals as a Team Leader to accomplish company and team goals.
Essential Job Responsibilities:
People/Organization Management and Development:
- As a standing member of the regional Management Team, contributes to the development of the department's strategic direction.
- Proactively assesses constraints for their assigned programs and departmental projects to mitigate risks.
- Contributes to creation of PM budgets and resource estimates for functional area, provides oversight of resources, and contributes to the management of the regional PM budget.
- Ensures bridging and integrated functioning with Medical Affairs and Business Development as well as Drug Development Research, Quality Assurance, Regulatory Affairs & Pharmacovigilance, Technology, and Sales and Marketing.
- Develops skills of group members to meet Astellas' short- and long-term strategic needs.
Performance and Resource Management:
- Contributes to the creation and use of an integrated single PM set of project management standards, processes, methodologies and tools in Development.
- Provides input into the optimal development, allocation and management of PM resources to Development global / local project teams, for the assigned therapeutic area(s).
- Direct supervision and mentoring of 2 or more individuals.
- Contributes to the hiring, training, assessment, development and promotion of PM staff where it involves the Team.
- Contributes to the training and development of departmental staff. Manages assigned Team resources and contributes to regional planning and management of departmental budget and resources.
- Leads, coaches, and supports direct reports in providing best in class project management support to Astellas drug development programs.
- Provides oversight and guidance to direct reports in completing program deliverables according to agreed timelines and quality standards
- Collaborates with multiple stakeholders in a matrix environment for the optimization of departmental processes for regional and global project management.
- Strives to maximize team performance, global alignment, and drives PM practice and project management methodology to further professionalize the function.
- Contributes to the management and allocation of internal (PM) and external resources to projects assigned to the Team.
- Monitors and evaluates performance of direct reports, including adherence to timelines, standards and processes for work assigned.
- Where applicable, displays oversight of PM vendors; manages metrics systems to impact deliverables. Proactively works with assigned teams to meet Astellas' standards and maintains quality requirements.
- Ensures compliance of the Team 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.
- Oversees the execution of project management to support drug development, registration, marketing, product maintenance, as applicable, and in-licensing for the assigned set of projects and, within the group, absorbs new projects signaling for additional resource needs while making optimal use of available resources.
- Within the therapeutic area(s) assigned to the Team, the Team Leader will be directly responsible as a PML, RPR and/or LPL for the most advanced and complex projects in PM. Details of associated responsibilities are listed in the job description for the function of Associate Project Management Director.
- Oversees a suite of projects assigned to direct reports to ensure integrated functioning within GD project management and within the PM department.
- Participates in development of Project Management-specific objectives and plans and for projects assigned and overseen.
- Develops and implements plans to achieve objectives.
Manages and coordinates activities in Core Teams.
Two or more direct reports, project management functions (grades ranging from D-13 to D-17).
All personally assigned Dev drug development projects and team-assigned Dev projects for oversight, plus process / change management project(s), proportionally distributed among Team Leaders and staff in terms of workload.
Responsible for approximately 2 to 10 projects including local and global projects across multiple phases with budgets totaling approximately 100-200 oku-yen (approx., 100-200 million USD).
Project management functions reporting to Team Leaders (TLs) may include (Senior) Project Associates, (Associate/Senior) Project Managers and Associate Project Directors. In the US, the reporting to TLs in PM is a highly delegated role while the regional Departmental Head 'owns' the HR budget. The TLs report directly into the Senior/Executive Director, who is member of the DPM Leadership Team. TLs are ad-hoc members of DPM Leadership Team. A Project Management Associate may be added to Teams, primarily to support the Team Leader; supports Team Members where the TL deems appropriate.
- Master degree or equivalent Project Management Experience with 10+ years Pharmaceutical R&D and 5+ years International DD process or Doctorate a plus, PM certification (e.g., PMP, PgMP, PMI-RMP, PRINCE2) a plus with 7+ years Pharmaceutical R&D and 5+ years International DD process
- Demonstrated excellence in communication, negotiation/influencing, people management and social skills with a good sense of diplomacy in a scientific, industrial and commercial environment, both relating to team members, peers, and higher management.
- Demonstrated ability to lead/mentor people.
- Active and passive skills in English, leading and attending meetings, presenting and training.
- Language skills in 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 and successful track record of accomplishing high quality results through team level performance. Competent and experienced mentor capable of developing senior level professionals.
- Capable of making quick assessments, taking corrective action using good judgment and appropriate decision making steps; proven proactive problem-solving skills.
- A key organizer who has shown to set clear priorities and goals on developmental activities, team development, and finances with experience in financial reporting and planning systems. In-depth knowledge of the global drug development process, including proven history of successful, multidisciplinary program management experience, which includes leadership in more than one IND/CTN, NDA/CTD, Advisory Committee or other major FDA / EMA / PMDA submissions and/or meetings; hands-on experience with drug registration is an advantage.
- Scientific academic background supportive of acquiring knowledge of Astellas' project and product range within the assigned therapeutic area(s).
- 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 and across time zones.
- People management experience a plus
- Understanding the implementation and impact of regulatory requirements and guidances / PM concepts. Experience with co-licensing development desired.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled