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 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 Director, Medical Affairs Canada leads, manages, and supports all aspects of Canadian Medical Affairs strategy and is accountable for the implementation of medical tactics for Kyowa Kirin Canada. This person serves as an integral member of internal cross-functional teams, the Canadian management team, and the Kyowa Kirin North America (KKNA) Medical Affairs Leadership team. This role is accountable for Medical Affairs interactions with internal/external stakeholders, including but not limited to Canadian Medical Affairs strategy, Evidence Generation, and dissemination including publications, Sponsored testing programs, promotional material review, and medical material review, Medical materials generation and review, Medical Information, Medical Education, Medical Training, Special Access Programs, and Compassionate Use Programs. This role will also support Canadian MSL activities.

Essential Functions:

• Develop and drive the execution of Canadian Medical Affairs Strategic Plans for Oncology, Rare Disease and other therapy areas, aligned with company strategic imperatives and the KKNA and global Medical Affairs Strategies, working closely with KKNA Medical Affairs therapeutic area leads and KKNA MSL Head.
• Responsible for Canadian sponsored testing programs, including protocols, implementation, and oversight.
• Lead and execute medical tactics in support of Canadian Health Technology Assessment (HTA) submissions and presentations, and reimbursement negotiations with payors, for new Kyowa Kirin products and indications.
• Direct, design, and coordinate Canadian evidence generation plans and publication plans, in collaboration with KKNA and 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.
• 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.
• Support the development and execution of compliant accredited and unaccredited learning programs for Healthcare Professionals.
• Provide medical affairs training to internal stakeholders, including Marketing and Commercial teams.
• Create Medical Affairs materials and communications such as slide decks, FAQ documents, and medical information letters to address Canadian stakeholder needs, based on insights gathered from MSLs and other internal stakeholders.
• Provide medical review of promotional and medical materials.
• Provide input into KKCA and KKNA regional planning and budgeting process; track and manage Canadian Medical Affairs budget.
• Facilitate sharing of Medical Affairs best practices across therapeutic areas and regions.
• Develop and implement relevant Canadian Medical Affairs work instruction documents, Standard Operating Procedures and Policies, in collaboration with Legal and Compliance Canada.
• Ensure compliance of Canadian Medical Affairs activities with respect to applicable laws, regulations, SOPs, policies, processes, and compliance guidelines.
• Other duties may reasonably be assigned.

Education

Advanced degree in Health Sciences (MD, PhD, PharmD) or closely related discipline.

Experience

This position requires a minimum of five (5) years of relevant industry experience, including Medical Affairs. Experience in Rare Disease is preferred. Proven track record, including overseeing product launches and lifecycle management. Deep understanding of pharmaceutical R&D, clinical and commercialization processes in Canada. Current knowledge of all relevant industry, legal, and regulatory compliance guidelines. Excellent written and spoken English. French proficiency is preferred. 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 Canadian HTA reviews and reimbursement negotiations for new drugs and indications. Commitment to the highest ethical, legal, regulatory, and scientific standards. Eligibility to work in Canada.

Technical Skills

Outstanding leadership abilities include demonstrated capacity to lead, inspire and build collaborative relationships. In-depth understanding of drug development, legal and regulatory compliance guidelines. Excellent communication skills (written, verbal, listening, and presentation). Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.

Non-Technical Skills

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Commitment to the highest ethical, legal, regulatory, and scientific standards in all aspects of work 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.

Travel

Requires up to 20% domestic and international travel.