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 CMO is a strategic partner for the Therapeutic Area Franchises, leading a dynamic team and overseeing medical strategy and operational execution with excellence for marketed products and products in development, in addition to providing expertise in business development initiatives, as required.

The CMO works closely with the Research and Development organizations driving overarching scientific leadership specifically in Hematology/Oncology, Bone Mineral, Rare Disease and Gene & Cell therapies, and in future therapeutic areas that may arise.

As a key member of the North American Executive Committee, the CMO enables superior results for patients through discussions and decisions that focus on execution, developing capabilities, problem-solving and developing people and our culture, while embedding compliance in all activities.

As a key member of the Global Medical Affairs (GMA) Leadership Team, the CMO contributes to the development and execution of the GMA Strategy, maximizing the value of Kyowa Kirin medicines for patients.

The CMO will also be the medical leadership face and voice of Kyowa Kirin North America to various external constituencies, including healthcare professionals and patient organizations.

Key Responsibilities

• Oversee development and execution of Kyowa Kirin North American Medical Affairs strategies for all therapeutic areas, including marketed products, pre-launch products, and Life Cycle Management (LCM), including the generation of relevant clinical and outcomes data to support patient access to Kyowa Kirin products.
• Provide medical input to the Franchise Brand Planning process and the launch readiness planning process.
• Develop and lead North American evidence generation strategies and execution, including Real World Evidence, Health Economics and Outcomes Research, Investigator Initiated Studies, Collaborative Research and Corporate Sponsored non-registrational studies.
• Contribute to the development and execution of Global Medical Affairs Medical Strategy Documents and Evidence Generation plans.
• Drive impactful publications, evidence dissemination and scientific/medical communications
• Incorporate the patient voice and perspectives into medical and corporate plans and deliverables
• Lead the development of strategic partnerships with healthcare professionals, academic medical centers, professional societies and other key external stakeholders.
• Chair Kyowa Kirin North America Medical Affairs governance committees and participate on Global Medical Affairs and other Kyowa Kirin North America governance committees
• Oversee medical review on Medical Review and Promotional Review Committees.
• Build and strengthen capabilities and evolve the organization to meet the challenges of the dynamic healthcare environment
• Ensure compliance with legal and regulatory laws and policies in all activities.
• Support KKNA Medical Affairs to enable sound ethical decision-making

Education

• An MD degree is required for this role.

Position Requirements

• This position requires a minimum of 15 years in pharmaceutic industry with Medical Affairs leadership experience
• In-depth understanding of the US and Canadian healthcare landscape is required.
• Strong command of the drug development process, regulatory environment, and legal and compliance regulations governing Medical Affairs activities is required.
• Clinical development experience is preferred.
• Broad therapeutic area exposure across multiple therapeutic areas is highly preferred.
• A strong scientific sensibility is required.
• Exemplary leadership qualities with broad and formal leadership experience, including the ability to build and develop a high-performing organization/team and lead cross-functional collaboration is required.
• Outstanding stakeholder management with the demonstrated ability to engage in close communication and foster effective decision-making is required
• Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences, including key thought leaders, investigators, patients, regulatory agencies, investors, current and potential partners, media, and internal audiences, including senior leadership is required.
• A track record of driving innovation and organizational transformation is required.
• This position will require 30-40% domestic and international travel.
• This role will be based in Princeton, NJ

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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller's data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

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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