Director, Project Management (Drug Development)
Company: Astellas Pharma
Location: Northbrook
Posted on: May 28, 2023
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Job Description:
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:
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:
Strategy:
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.
People/Organization Management and Development:
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.
Performance and Resource Management:
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.
Project Management:
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.
Quantitative Dimensions:
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).
Organizational Context:
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.
Qualifications:
Required
Master's Degree or equivalent Project Management Experience
7+ years Pharmaceutical R&D
Previous experience with the drug development 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).
Understanding the implementation and impact of regulatory
requirements and guidance / 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 and across time zones.
Preferred
Doctorate a plus, PM certification (e.g.,PMP, PgMP, PMI-RMP,
PRINCE2) a plus
10 + years Pharmaceutical R&D
5+ years of International drug development experience
Prior people management experience
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus
national holidays including Heritage Days, and Summer and Winter
Breaks
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
#LI-SS
Category Development Project Management
Astellas is committed to equality of opportunity in all aspects of
employment.
EOE including Disability/Protected Veterans
Keywords: Astellas Pharma, Chicago , Director, Project Management (Drug Development), Executive , Northbrook, Illinois
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