Scientific Director, Global Medical Affairs (Hematology)

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

The Scientific Director, reporting into the Global MA Product Head Mogamulizumab, will support the Global MA Product Head in the planning and execution of Global Medical Affairs activities for mogamulizumab in hematology-oncology, building and facilitating highly effective collaborations and alignment with regional and country medical leadership, as well as other key cross-functional stakeholders.

Responsibilities include supporting the development and execution of the annual Medical Strategy Document and the Evidence Generation Plan; creating and executing the global medical publications and communication plans for mogamulizumab, including congress planning, relevant global training on product and disease evidence and management; and development of global medical information materials to ensure industry-leading global medical affairs capabilities.

This position will provide leadership to support the additional global medical functional activities, including global advisory meetings, global medical internal meetings and global medical studies and evidence generation, in collaboration with the Global Product Head.

Essential Functions

• Product and disease Subject Matter Expertise
• Support the Product Head in the development of the Global Medical Affairs Strategy Document for mogamulizumab (Hematology Oncology),
• Support the development of the Evidence Generation Plan Document providing leadership and oversight of its execution including KPI tracking and proactive problem solving to ensure successful and timely deliverables in collaboration with stakeholders.
• Contribute to the design and implementation of global clinical studies in oncology,
• Lead development and the effective and appropriate execution of the overarching global publications and communications plans.
• Create and review global medical response documents for accuracy, quality, and completeness.
• Lead and/or support creation, development, internal review, and alignment for all global medical affairs programs, including execution and communication of quarterly global insights reports, research portfolio reviews and gap analyses, scientific statement workshops, global medical meetings and global medical-led cross-functional meetings.
• Lead and/or support other external scientific/medical operational activities such as global advisory board planning and disease or research consultation; and support global key external expert interactions.
• Serve as a subject matter expert for the program for product data and disease area evidence.
• Collaborate with project managers to develop global budgets for global program tactics, including global publications/communication, global medical materials, training, and global studies.
• Support additional projects and assignments as needed.
• Ensure adherence to all applicable company SOPs, policies, and processes.
• Serve as delegate for Global Product Head as needed.

Job Requirements

Experience

Minimum of 7 years of hematology/oncology experience in Medical Affairs within the pharmaceutical industry highly preferred. Deep understanding of pharmaceutical regulatory requirements and environment, as well as all applicable industry guidelines and requirements for compliance. Proven ability to build internal and external networks and to collaborate across geographies and cultures, enterprise leader mindset. High competency in driving operational change and continual process improvement. Strong analytical mind-set and ability to distill information into key messages and actions. Results focused and accountable for deliverables including proactive problem-solving and risk mitigation. Possess uncompromising integrity. Champion robust science and patient-centricity. Effectively interact with Key External Experts Ability to manage multiple projects in a fast-paced environment with multiple stakeholders; simultaneously ensuring attention to detail when needed. Strong written and oral communication skills

Non-Technical Skills

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. A strong wo