Senior Director Medical Affairs, Oncology

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.

The Senior Director of Medical Affairs in Oncology provides exceptional medical leadership for creating and implementing medical affairs strategies, plans, and tactics for the current products and pipeline portfolio in Oncology for the North American region. This is done in alignment with the Global Medical Affairs and corporate strategy.

Position Responsiblities:

• Providing inspirational, strategic medical/scientific leadership for the KKNA Medical Affairs Oncology team, cultivating a culture of teamwork and collaboration to make a profound impact for on patients
• Providing medical and scientific subject matter expertise, evidence generation study design, review, and execution; data analysis and interpretation; publications, presentations, and medical communications; medical content development and review; medical education and training; medical information; scientific exchange and collaboration
• Building strategic medical relationships and partnerships with Key Opinion Leaders, academic and medical institutions, Professional associations, and community networks, together with Medical Scientific Liaisons.
• Serving as the principal contact with internal stakeholders, representing Medical Affairs on internal cross-functional and global teams
• Responsible for the KKNA Oncology Medical Strategic Plan and management of resourcing and budget
• Supporting Global Medical Affairs
• Ensuring that the patient is in at the center of all activities, upholding the Kyowa Kirin core values of Commitment to Life, Innovation, Integrity, and Teamwork/WA.

Essential Functions:

• Develop and implement KKNA Oncology Medical Affairs Strategy and tactical plans aligned with North American and global strategic imperatives and in collaboration with internal stakeholders  
• Engage with external partners and stakeholders, including Key Opinion Leaders, Professional associations, community networks, and patient advocacy groups to innovate and refine medical affairs strategies, together with Medical Scientific Liaisons
• Represent KKNA Medical Affairs on cross-functional internal teams and internal review committees (MRC and PRC) 
• Direct, design and coordinate Medical Affairs evidence generation activities 
• Lead the development and implementation of strategic and tactical publication plans 
• Support Medical Affairs training in the development and delivery of the Oncology Medical Affairs training plan, materials, and certifications, and support commercial training activities
• Direct development and dissemination of medical information materials and vendor training including medical information letters and FAQ documents 
• Provide Medical Affairs support and input into launch readiness activities including labeling, life cycle management, and other early commercialization initiatives for late-stage Oncology pipeline products. 
• Prepare, manage, process, and reportingreport  forfor report budgets for assigned products, 
• Oversee vendor-related activities (selection, contracting, onboarding, day-to-day operation, performance evaluation, and improvement).
• Coach, manage, and support team members; actively manage talent and career development
• Ensure adherence to all applicable SOPs, policies, processes, and compliance guidelines and uphold the highest standards of compliance, ethics, and safety
• Foster a culture of diversity and inclusion, patient-centricity, and commitment to Kyowa Kirin's core values

Education:

Advanced degree in Health Sciences or related fields (MD, PhD, PharmD) is required. 

Experience:

• Oncology experience preferred. Minimum of 8+ years of relevant industry experience. Successful track record of overseeing product launches and lifecycle management. People management experience is required.

Technical Skills:

• Proficient in MS Office Suite.

Non-Technical Skills:

• Strong interpersonal, written, and oral communication skills are essential, including strong presentation skills and the ability to effectively communicate with a diverse range of stakeholders.
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