Associate Director, Global Project Management

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

Summary:

Associate Director, Global Drug Development Project Manager, will serve as a global drug development project manager and provide professional services to global development projects and One Kyowa Kirin. The Associate Director, Global Drug Development Project Manager will manage clinical stage integrated drug development projects and ensure projects are delivered on time, budget, and quality using proven project management decision support tools and strong leadership skills. The Associate Director, Global Drug Development Project Manager will provide cross-organizational support to accomplish annual business plan goals.

Essential Functions:

•    Serves as a critical integrator on the development project team and applies the proven PM tools & techniques that ensure success coupled with the leadership skills to rapidly build and motivate productive teams.
•    Budget Management: creation of accurate integrated budget estimates, monitoring of project budget throughout course of project and proposing revisions to project budget as needed (change control process) in line with project plans.
•    Schedule Management: creation of an integrated project schedule in collaboration with project team members, that represents the full scope of the project with critical path. Monitoring project progress and deliverables compared to the governance approved project plan, and proposing revisions to the project schedule, as needed.
•    Resource Management: creation of FTE estimates in collaboration with project team members, monitoring of FTE usage throughout course of project and proposing revisions to resource plan as needed.
•    Risk Management: identify, monitor, and report on the risk factors influencing clinical, CMC, non- clinical, and regulatory development plans. Support team members to identify risk mitigation plans and ensure cross-functional risk management and reporting.
•    Communication Management: Facilitates project level communication across functions and regions and manages core team documents. Ensures transparency of project progress across the organization. Ensures optimal team performance by sharing cross- program best practices and lessons learned.
•    PM Systems: Utilizes existing PM systems and tools to create and manage timelines, WBS and collaborate across the teams virtually.
•    Understands organizational requirements to effectively manage and progress projects, including governance meetings and approval processes, and responsibilities of other functions/divisions. Ensures project teams follow the global development framework and governance process.
•    Contributes to Global Project Management function objectives, tasks and goals.
•    Contribute to and lead change management efforts throughout the organization.
•    Able to influence the team to drive results without authority and work in a global environment.
•    Collaborates with other project management functions in One Kyowa Kirin to progress business objectives, share and standardize best practices.
•    Collaborates with alliance partners.
•    Identifies opportunities to provide coaching and mentoring globally.

Requirements:

Education
Bachelor’s degree with scientific focus required. Project Management certification is preferred. Six Sigma certification and/or similar experience is a plus. Knowledge of US, EU and Japan clinical development regulations is desirable.

Experience
7 years of experience in the pharmaceutical industry including 5 years in a relevant clinical drug development project management role. Thorough understanding of both theoretical and practical aspects of Project Management. Strong Project Management skills across all phases of a project. Additionally, experience working with partners/alliance management is preferred.

Technical Skills
Proficient in MS Office Suite. In-depth knowledge of MS Project or Planisware. Experience with MS Tools including Excel, Power Point and Word for effective budget management, communication, and representation of data/information. Ability to utilize telecommunication hardware and software required to hold in person and/or virtual business meetings between remote sites, including teleconference, videoconference and web conf