Drug Development Project Manager- Associate Director

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 three 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.

As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.

Summary:

Serve as a global drug development project manager and provide professional services to global development projects and One Kyowa Kirin. 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. 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, 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 input of all team members and documents decisions made. 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

    Must have a minimum of 7 years of experience in the pharmaceutical industry including at least 5 years in a releva