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.
• Direct experience is required in developing and presenting/training medical materials to both medical and non-medical audiences.
• This includes expertise in medical information, publication planning, and publication content.
• Deep understanding of pharmaceutical research and development (R&D) and commercialization processes is necessary, as is an in-depth knowledge of the principles and practices of pharmaceutical clinical studies, including study design, conduct, analysis, and reporting.
• Fluency in Good Publication Practice, ICMJE guidelines, and other relevant industry guidelines is expected.
• Strong analytical skills, attention to detail, and the ability to manage and prioritize multiple projects from start to finish in a fast-paced environment are critical.
• The ability to work effectively in cross-functional teams, including those spanning across different geographies and cultures, and with individuals possessing diverse skill sets and personalities is also necessary.
• Being a team player, flexible, adaptable, and having the ability to develop good working relationships both internally and externally is important. Additionally, the individual should be an innovative self-starter with a strong work ethic and integrity.

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 [email protected]. Controller’s data protection officer can be contacted at [email protected]. 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 [email protected].

Recruitment & Staffing Agencies

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.

#LI-Hybrid

#-LI-JM1