Senior Director, Medical Affairs Canada

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 Senior Director, Medical Affairs Canada leads, manages, and supports all aspects of Medical Affairs strategy and is accountable for the implementation of medical tactics for the Canadian Kyowa Kirin organization and serves as an integral member of internal cross-functional teams and Canadian management team, and the Regional Medical Affairs Leadership teams. This role is accountable for interactions with internal/external stakeholders with respect to Medical Affairs strategy, Evidence Generation, and dissemination including publications, development, and execution (including Standard Operating Procedures) of sponsored genetic testing programs, Medical Information, Medical Education, Medical Training, Special Access Programs, and Compassionate Use Programs. This role will also be responsible for leading therapeutic area teams of Medical Science Liaisons in Canada.

Essential functions:

• Develop and drive the execution of Canadian Medical Affairs Strategic Plans aligned with company strategic imperatives and regional/global Medical Affairs Strategy.
• Responsible for the Canadian genetic testing protocols, implementation, and oversight.
• Lead the medical input for all Canadian HTA (CADTH and INESSS) submissions and presentations.
• Direct, design, and coordinate Canadian evidence generation plans and publication plans, in collaboration with Global Medical Affairs and support Investigator Initiated Studies.
• Oversee appropriate and compliant scientific exchange with the external healthcare professional (HCP) community, KOLs, and investigators through robust, fair-balanced, and timely communication of medical and scientific information on the company’s products and disease states.
• Provide robust, up-to-date, and timely scientific and clinical information and input in respect of Health Technology Assessment (HTA) review and reimbursement negotiations, for new Kyowa Kirin products and indications.
• Ensure appropriate representation and discussion of medical and scientific information on the company’s products in settings such as advisory boards, presentations to payers, and formulary decision-makers.
• Recruit, hire, train, develop, and retain a high-performing MSL team.
• Develop and implement strategic MSL field/territory plans and objectives in alignment with Medical Affairs and corporate strategy and oversee the successful execution of these plans.
• Lead the identification of national and regional KOLs and the development of KOL engagement plans.
• Direct MSL attendance and coverage at congresses and meetings, including contributing to meeting planning through collaboration with internal stakeholders.
• Support the development and execution of compliant accredited and unaccredited learning programs for Healthcare Professionals.
• Compile, assess, organize, collate, and summarize insights gathered by the Canadian Medical Affairs, including the MSL team, and ensure regular sharing of this feedback to internal colleagues to inform actions such as continual improvements to processes and materials, potential business opportunities, informing research, clinical trials, and company strategy.
• Develop MSL-appropriate goals and objectives and assessment processes to track and report the performance of the MSL team and report metrics.
• Identify MSL educational needs and contribute to the development of the MSL training plan coordinated by Global and KKNA Medical Affairs
• Provide appropriate training, mentoring, and coaching to direct reports with respect to scientific knowledge, product knowledge, technical skills, business acumen/planning, and effective regional management, including frequent field visits with the MSL team; manage individual and team performance.
• Provide medical affairs training to internal stakeholders, including Marketing and Commercial teams.
• Create and/or adapt NA Medical Affairs materials such as slide decks, FAQ documents, and medical information letters.
• Provide medical review of promotional and medical materials.
• Provide input into KKNA regional planning and budgeting process; track and manage Canadian Medical Affairs budget.
• Facilitate sharing of best practices across therapeutic areas.
• Ensure and enforce compliance with all regulations, laws, SOPs, policies, processes, and compliance guidelines.

Education:

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

Experience

Rare Disease experience preferred. Minimum of 8+ years of relevant industry experience, including Medical Affairs. Proven track record, including overseeing product launches and lifecycle management. Deep understanding of pharmaceutical R&D and commercialization processes in Canada. Current knowledge of all relevant industry, legal, and regulatory compliance guidelines. Previous leadership and people management experience. Excellent spoken and written English is mandatory. French proficiency would be considered an asset. Excellent oral, written, and presentation skills and ability to effectively communicate with a diverse range of stakeholders. Strong analytical skills, attention to detail, and ability to manage/prioritize multiple projects from conception to completion in a fast-paced environment. Ability to work well in cross-functional teams (across geography and culture) with people with diverse skill sets and personalities. Team player, flexible and adaptable. Ability to build strong, trusted working relationships, both inside and outside the organization. Knowledge of, and experience supporting HTA reviews for new drugs and indications. Commitment to the highest ethical, legal, regulatory, and scientific standards. Eligibility to work in Canada without sponsorship. Knowledge and expertise with Canadian HTA authorities.

Technical Skills

Proficient in MS Office Suite.

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 work ethic is required. Detail-oriented and excellent follow-through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high-growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

Physical Demands:

Normal office environment with prolonged sitting and extensive computer work

Working Conditions:

• Hybrid Workplace (up to 2 days per week in-office)
• Requires up to 20% domestic and international travel

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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