Senior Director, KKNA Medical Affairs Operations and 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 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 of Job:

As a core North America (NA) Medical Affairs (MA) team member, the Sr. Director will be accountable for the leadership and oversight of operations and project management in NA MA. As a leader, the individual will foster a positive, compliant, and collaborative culture to drive a mission of customer and stakeholder satisfaction, employee engagement, business impact, and organizational and process excellence. The Sr. Director will continue to build and develop the Operations and Project Management capabilities to support the current and future growth of NA MA. This role will lead the development of NA MA operational and project management methodologies and practices, further increasing the robustness of NA MA project delivery, talent management, operational excellence, organizational design, and fiscal responsibility.

Essential Functions:

Leadership and People

• Establishes the Medical Affairs Operations and Project Management vision and roadmap, which is aligned with and supports NA MA’s strategic priorities and long-term vision.
• Contributes to the development of Medical Affairs mid and long-term strategy, working in partnership with the Therapeutic Areas and the Chief Medical Officer of North America.
• Defines the people, processes, and technologies/applications necessary to provide a framework for achieving operational excellence and project management expertise.
• Provides leadership, coaching, and management of the NA project managers and operational excellence managers.
• Continually assesses the needed capabilities for building and maintaining an MA operations and project management team.
• Fosters a culture of excellence, compliance, collaboration, and continuous learning within the team and across the MA organization.
• Contributing member of the Medical Affairs Leadership team.
• Establish trusted partnerships with finance, franchises, and the medical affairs teams to establish operational and resource requirements for budgets. Develop and provide status and guidance on monthly/quarterly/annual reporting and budget performance.
• Provide project management expertise to support the Medical Affairs team.

Operational

• Develops methodologies and tools to support project management best practices and philosophies. Drives the adoption into all work aspects to enhance Medical Affairs effectiveness and performance.
• Works cross-functionally with stakeholders and customers (TA, Legal, Compliance, Regional and Global MA functions), and to determine the controls, methods, and procedures required to support the execution of MA activities per regional requirements, industry standards, and MA objectives.
• Leads development and maintenance of SOPs, Work Instructions, and supporting operational documents, ensuring alignment with KKC Codes of Conduct, Group Policies, and NA legal and compliance policies/procedures.
• Defines and implements methodologies and applications, including templates, scheduling, and reporting tools, required to establish a flexible, scalable, and sustainable NA operations infrastructure.
• Leads the identification, development, and implementation of process improvement initiatives to enhance operational efficiency and effectiveness within Medical Affairs Operations.
• Serves as administrator of governance, leadership, and review committees assigned.
• Collaborates with stakeholders and customers to design, implement, and lead complex major organizational projects with cross-functional scope and high impact. Inclusive defining success measures, managing cross-functional teams, risk assessments and mitigations, schedules, monitoring, and reporting against program goals.
• Defines internal department performance measures, which provide actionable feedback and data to drive improvements and efficiencies and facilitate more vital, robust decision-making.
• Establishes and manages external relationships with vendors and partners, serving as a critical point of contact.
• Regularly assess the industry’s best practices, internal needs, challenges, and opportunities. Identify and adopt fit-for-purpose standards to increase compliance and understanding of the MA organization.
• Defines and executes training requirements of operational processes and completes periodic reviews of compliance and performance to identify inefficiencies and enhancements
• Oversee Medical Affairs audit and compliance management. Including serving as a point of contact for internal audits, developing CAPAs, and supporting key customers during Health Authority Inspections.
• Leads the development of standard reporting for NA MA, including providing monthly reports and action plans that offer insights into enhancing MA performance. Contributes to identifying new business reports that deliver insight into performance and facilitate decision-making.

Subordinates: Project Managers, Operations Excellence Managers, additional reporting roles as defined

Job Requirements:

Education: Master's degree, PhD, PharmD, or equivalent. Project Management degree or certificate or PMP preferred

Experience: 10+ years of relevant experience in the pharmaceutical or biopharmaceutical industry, operations, and project management, including prior managerial and operations experience. 7+ years of medical affairs experience required in project management or operational management.

Technical Skills: Analytical tools/applications, MS Office Suite, Veeva system suite

Non-Technical Skills:

Cultural sensitivity and the ability to foster consensus within a multinational organization. Proficient in leading and managing during periods of growth and within a dynamic environment. Capable of applying strategic and critical thinking to address issues and identify opportunities. Skilled at evaluating critical business challenges and directing the execution of operational support processes and tools that have a cross-functional impact. Strong analytical skills, keen attention to detail, and a focus on business processes. Proven track record in financial planning, budget management, and resource allocation. Excellent interpersonal and communication skills (both written and verbal) with the ability to effectively engage with all levels of the organization confidently. Demonstrated ability to develop effective and collaborative

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.

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