Scientific Director, AML Medical Strategy & Communications

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 translate science into smiles by delivering therapies 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, North Carolina, and Mississauga, Ontario.

Summary of Job:

The Scientific Director, AML Medical Strategy and Communications will serve as a key leader within the North America Medical Affairs team in working with our alliance partner to help develop and shape medical strategy for a novel product(s) in AML and contribute to strategy across KKNA Oncology and the Oncology collaborative scientific and communications platform. Working closely with the Sr. Director – Oncology, this role will be responsible for shaping strategic direction, driving strategic projects, determining educational needs, and providing operational leadership for several areas. The Scientific Director is also a key member of internal cross-functional teams, and NAMAC (North American Medical Affairs Committee). This individual will serve as the central contact with internal/external stakeholders with respect to certain projects key external expert (KEE) planning, congress planning, and medical operations.

Essential Functions:

Focus on Strategy with internal/external stakeholders:

• With alliance partner company, serve as KKNA Medical AML Medical lead and contribute to medical strategic plan as well as provide input to the Oncology Integrated Evidence Plan to guide purposeful data generation
• Partner with the Oncology Sr. Director of Medical Affairs and contribute to the development of Medical Affairs strategy for commercialized product
• Serve as lead AML Medical reviewer in promotional review process and ensure materials are scientifically accurate, current, and properly substantiated and referenced
• Serve as Investigator-sponsored studies (IIS) lead to evaluate new proposals and provide oversight of existing IIS across Oncology
• Provide medical strategic input during Franchise or Joint Collaborative Team Meetings
• Represent KKNA at major scientific conferences and advisory boards to communicate medical insights and establish thought leadership in Oncology
• Build and maintain relationship with KEEs, healthcare systems, and advocacy organization
• Provide medical guidance and training to the cross-functional Oncology team and share relevant insights to contribute to strategy as well as support Medical Value Outcomes Liaisons, KKNA Medical Science Liaisons and relevant field teams
• Contribute to key decision-making as a member of the NAMAC (North American Medical Affairs Committee) team

Focus on teamwork and cross-collaboration:

• Align with and support other scientific/medical operational activities such as advisory board planning and execution, Medical Information tactics and MSL Training.

Other:

• Ensure adherence to all applicable SOPs, policies, processes, and compliance guidelines.
• Oversee vendor-related activities (selection, contracting, onboarding, day-to-day operation, performance evaluation, and improvement).
• Additional projects and assignments as needed

Job Requirements:

Education

Advanced degree in Health Sciences or related field (MD, Ph.D., DNP, PharmD).

 

Experience

7 to 10 years of industry experience in Medical Strategy at pharmaceutical companies or at consulting agencies in the same respective area. Past record of success in determining medical affairs therapeutic area strategy. Direct experience with medical strategic planning and working with alliance partners are preferred. Deep understanding of pharmaceutical R&D and commercialization processes. Good knowledge of principles and practices of pharmaceutical clinical studies (including design, conduct, analysis, and reporting). Familiarity with Good Publication Practice, ICMJE guidelines, and other applicable industry guidelines.

 

Technical Skills

Proficient in MS Office Suite.

CMPP (Certified Medical Publication Professional) credentials are recommended.

Non-Technical Skills

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal w