Director, Global Drug Development Project Management
4 weeks ago
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 disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
Summary:
The 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 selected candidate will manage integrated drug development projects across the full scope of the development paradigm and ensure projects are delivered on time, budget, and with high quality using proven project management decision support tools and strong leadership skills. The Director, Global Drug Development Project Manager will deliver goals across the global development and Project Management organization 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
10 years of experience in the pharmaceutical industry including 5 years in a relevant 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 conference tools.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.
Recruitment & Staffing AgenciesKyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
#LI-TT1 #Drug Development #Hybrid
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