Director Medical Affairs Canada

Kyowa Kirin is a fastgrowing global specialty pharmaceutical company that applies stateoftheart biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japanbased 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 crossfunctional 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 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 l 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 fairbalanced and timely communication of medical and scientific information on the companys products and disease states.
• Ensure appropriate representation and discussion of medical and scientific information on the companys products in settings such as advisory boards presentations to payers and formulary decisionmakers.
• Support the development and 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 fastpaced to work well in crossfunctional 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 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. Indepth 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.

NonTechnical 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 fastpaced 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.

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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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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