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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.

Résumé du poste:

L'adjoint(e) administratif(ve) de direction joue un rôle essentiel en soutenant les opérations et les projets canadiens au sein de la filiale canadienne. Ce poste jouera un rôle clé dans un environnement hautement matriciel, en appuyant le directeur général (DG) et les membres de l'équipe de direction canadienne (LT) dans les activités auprès des clients ainsi que dans d’autres projets. 

Fonctions essentielles:

Fonctions de coordonnateur de projet: 
•    Soutenir les projets de l’équipe de direction canadienne. Responsable de la gestion et de l’exécution des projets ainsi que des processus opérationnels et logistiques liés aux activités auprès des clients, incluant la soumission et la gestion des demandes d’intégration des fournisseurs, l’approvisionnement et les paiements connexes. 
•    Rédiger, réviser et mettre en forme des gabarits, documents et communications à l’appui des activités auprès des clients et d’autres projets canadiens, en maintenant un haut niveau de rigueur, de précision et de professionnalisme. 
•    Planifier et coordonner les réunions, sur place et hors site, impliquant les membres du personnel, en organisant des réunions, en réservant les salles de conférence, en préparant et distribuant les supports de réunion, en coordonnant les besoins en matériel audiovisuel et en restauration, ainsi qu'en mettant en forme les documents en version finale. 
•    Coordonner diverses activités de projets transversales, incluant l’évaluation des besoins et la priorisation, tout en assurant l’alignement avec les objectifs et les échéanciers des projets.
•    Maintenir une communication régulière avec le directeur général et l’équipe de direction (LT), fournir des mises à jour sur l'état des tâches et discuter des priorités et autres questions pertinentes. 
•    Exécuter les directives de projet en collaborant avec plusieurs départements, incluant l’interaction avec d’autres groupes fonctionnels de Kyowa Kirin Amérique du Nord,, des partenaires externes et d'autres parties prenantes, afin de favoriser les relations et faciliter une communication efficace ainsi que la résolution des problèmes. 
•    Agir à titre de représentant des projets assignés en tant que responsables techniques et administratifs lors d'événements externes tels que réunions, conférences et engagements avec des fournisseurs selon les besoins. Effectuer toute autre tâche connexe assignée. 
Fonctions d' adjoint(e) administratif(ve) de direction: 
•    Responsable de la gestion des opérations et de la logistique du bureau canadien, y compris les appels téléphoniques, la correspondance et les demandes générales pour le bureau canadien, assurant le triage des dossiers auprès du département et du personnel appropriés 
•    Fournir un soutien administratif et de coordinateur complet au Directeur général et aux membres de l’équipe de direction, garantissant des opérations fluides et un flux de travail efficace. 
•    Gérer le calendrier du DG, en portant une attention proactive aux dossiers prioritaires et en assurant des réponses rapides aux courriels et aux autres communications.
•    Générer, éditer et formater des présentations à utiliser lors des réunions internes et externes  
•    Participer aux réunions selon les besoins, en préparant et en maintenant des comptes rendus détaillés afin de consigner les discussions clés et les éléments d’action pour les réunions de l’équipe de direction et autres rencontres. Gérer efficacement les documents à travers divers logiciels informatiques, démontrant une maîtrise de différentes technologies et une volonté de s'adapter et d'apprendre de nouveaux outils selon les besoins. 
•    Agir comme premier point de contact pour les communications internes et externes adressées au directeur général selon les besoins. Traiter les demandes générales par téléphone et par e-mail pour le(s) département(s), en traitant rapidement les questions de routine et non routinières et en identifiant les activités urgentes pour une résolution rapide. 

Exigences du poste:

Éducation 
Baccalauréat ou diplôme d’études supérieures en administration des affaires, en gestion ou dans une discipline connexe requis. La certification Project Management Professional (PMP) constitue un atout.
 
Expérience 
Minimum de quatre ans d'expérience en gestion de projet ou en soutien administratif aux équipes de direction, de préférence dans le secteur des sciences de la vie. L'expérience dans le soutien aux équipes de direction est un atout.  
 
Compétences Techniques 
•    Maîtrise avancée de la suite Microsoft Office (MS Word, MS Excel et MS PowerPoint). 
•    Maîtrise avancée des logiciels de gestion de projet, par exemple MS Project Capacité à prioriser efficacement les tâches, gérer plusieurs échéances et s'adapter à l'évolution des priorités dans un environnement rapide. 
•    Discrétion     dans     la     gestion     des     informations confidentielles/propriétaires. 
•    Capacité démontrée à travailler avec un ensemble diversifié de communautés – chercheurs, administrateurs, personnel technique et programmeurs – pour résoudre des problèmes et construire un consensus. 

Compétences Non Techniques 
Capacité démontrée à organiser, prioriser, respecter les délais, prendre des décisions et changer rapidement de cours d'action. De solides compétences interpersonnelles et de communication. Une éthique de travail forte est nécessaire. Attentionné aux détails et excellent suivi. Il a la capacité de faire preuve et de gérer l'ambiguïté dans un environnement dynamique, rapide et à forte croissance. Il a une passion pour l'apprentissage et le développement personnel afin de pouvoir évoluer au sein de l'entreprise. Sensibilité culturelle et capacité à développer un consensus au sein d'une organisation multinationale.

Le salaire prévu pour ce poste se situe entre 90 000 $ CA et 95 000 $ CA. Le salaire réel offert au début de l'emploi peut varier en fonction de plusieurs facteurs, notamment l'expérience pertinente, les compétences, les qualifications, la formation (y compris les permis et certifications applicables), les connaissances spécifiques au poste, le lieu de travail et d'autres besoins de l'entreprise et de l'organisation.

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.

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.

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:

The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations.

Essential Functions:

Risk-Based Quality Management (RBQM) Leadership
•    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance.
•    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors.
•    Integrate RBQM principles into study planning, execution, oversight, and close-out activities.
•    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy.

Central Risk Identification, Monitoring & Mitigation

•    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks.
•    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials.
•    Oversee centralized risk monitoring and trending to enable early detection of critical risks.
•    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons 

Learned & Risk Library Management (Core Ownership)

•    Establish and maintain a centralized Clinical Risk Library, capturing:
o    Known and emerging risks
o    Root causes
o    Mitigation strategies
o    Effectiveness of controls
•    Lead lessons learned activities across trials, audits, inspections, and CAPAs.
•    Ensure lessons learned are:
o    Systematically captured
o    Analyzed for trends
o    Fed back into RBQM planning, SOPs, training, and future studies
•    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness.

Quality Oversight & Regulatory Compliance

•    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs.
•    Provide centralized quality oversight across trials, CROs, and vendors.
•    Support audit and inspection readiness activities, including:
o    Risk-based inspection preparation
o    Impact assessments
o    CAPA development and effectiveness checks

Vendor & CRO Risk Oversight

•    Design and implement risk-based oversight strategies for CROs and external vendors.
•    Monitor vendor performance using quality metrics and risk indicators.
•    Lead or support quality governance discussions with external partners.
•    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework.

Data-Driven Quality & Continuous Improvement

•    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making.
•    Generate enterprise-level risk trend reports and insights for senior leadership.
•    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned.
•    Champion a culture of proactive quality and continuous improvement across Clinical Operations.

Cross-Functional Collaboration & RBQM Expertise

•    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance.
•    Provide RBQM training and coaching to study teams and cross-functional stakeholders.
•    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics.
•    Participate as an observing member on assigned study teams to provide real-time quality and risk support.

SOP Management & Governance Support

•    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates.
•    Support governance activities, senior management reporting, and quality metrics standardization.
•    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support.

Requirements:

Education
•    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required)
•    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred)

Experience
•    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM
•    Demonstrated experience leading enterprise or cross-study risk management frameworks
•    Strong background in audit/inspection readiness, CAPA management, and vendor oversight
•    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements

Technical Skills
•    Expertise with RBQM tools, centralized monitoring systems, and risk analytics
•    Experience defining and using KRIs, QTLs, and quality metrics
•    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI)
•    Exposure to AI or predictive analytics for quality monitoring (preferred)

Working Conditions:

Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines.

The anticipated salary for this position will be $190,000  to $ 205,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

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-TT1 #Hybrid #Princeton

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 territory covers - TX/OK/LA

 The Clinical Educator is required to exemplify strong disease state and treatment subject matter expertise and support to members of the Patient Services team. The Clinical Educator will be responsible for educating patients, family members, caregivers and HCPs, on certain disease states and treatments in a certain regional territory in the US.

The Clinical Educator will drive team territory business objectives and plans and deliver field excellence. The Clinical Educator will be responsible for a high standard of performance and compliant behavior. They will be expected to support the overall Patient Services strategy, policy and guidance development, marketing, and technology enhancements by acting as a subject matter expert in Clinical Education, with a strong background in Patient Services. Strong working knowledge of industry trends and requirements is necessary. This is a cross functional role and will collaborate with other functions to understand patient and customer needs and implement activities that align with Company strategy and comply with current regulatory and healthcare compliance guidelines.

The primary role the Clinical Educators is the delivery of on label, company approved clinical education programs to patients, families, and HCPs (RNs, NPs, PAs). The individual in this position will be responsible for a specific geographic area with the ability to travel between 50% and 75% of the time. The Clinical Educator will report to the Director of Clinical Education.

Essential Functions

• Provide company approved education on disease state and on-label product and treatment education to patients, families, patient organizations, and community groups, ensuring safe and effective use of KKUS products
• Deliver company approved, on label unbranded and branded presentations to HCPs to educate on disease state and KKUS product(s)
• Collaborate with other functions within the organization to understand patient and customer needs and identify, develop and implement educational activities that align with Company strategy and comply with current regulatory and healthcare compliance guidelines
• Deliver on established program metrics, key performance indicators, and performance measurements.
• Participate in PRC (Medical/Legal/Regulatory) review process as needed as a Clinical Education subject matter expert
• Collaborate with the training and operations verticals to develop and maintain all Clinical Education Program SOPs, Workflows, Communication Guides/Templates, Training and Reports
• Serve as liaison between other functions within the organization to ensure appropriate open communication of Company information
• Work with internal and external Patient Services partners (Hub, SPs, etc.) to ensure seamless patient experience on necessary customer touchpoints
• Maintain disease state understanding through continuing medical education by attending conferences and other educational opportunities
• Develop and maintain KKUS product expertise and understanding

Education

• Bachelor of Science in Nursing (BSN) degree or bachelor’s degree in the health care field; advanced degree preferred (MSN, NP, PA)

Experience

• Minimum three to five years of experience in the clinical setting, healthcare education, and/or medical industry.
• Rare disease experience preferred, metabolic bone disease experience preferred, along with expertise in community outreach work.
• 2+ years of pharmaceutical or biotech industry experience, preferred
• Expert knowledge of Clinical Education Solutions, including field CE, and patient support program strategy, operational processes, technology, and data
• Sufficiently experienced in working with vendors and cross functional partners; manage conflicts appropriately
• Home infusion and/or Infusion Center experience or knowledge
• Demonstrated ability to develop deep, effective working rapport to foster collaboration, and consultative relationships with healthcare professionals, patients, and caregivers, as well as internal matrix team
• Demonstrated ability to develop effective collaborative relationships within cross-functional teams
• Analytical and problem-solving capability, along with the ability to work independently
• Excellent English oral and written communication and presentation skills.
• Superior organizational and time management skills
• Desire to innovate and work in a fast-paced, energetic environment
• Ability to travel up between 50% and 75%

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. 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

Travel

Requires up to 75% 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.

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, Suite 6, 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.

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. 

The anticipated salary for this position will be $150,000 to $170,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

Kyowa Kirin provides a comprehensive compensation and benefits package which includes:

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, and Health Savings Account, Business Travel Insurance, Employee Assistance Programs
• Pet Insurance
• Retirement Savings 401k with company match and annual discretionary profit sharing
• Well-Being and Work-Life Programs Including Gympass, Nutrition Counseling, , Volunteer Time Off, Flexible Work Arrangements, Parental Leave, Adoption Assistance, and TouchCare Insurance & Billing Support
• Generous Paid Time Off, Sick Time, & Paid Holidays
• Perks and Discounts with Tickets at Work and LifeMart
• Reward & Recognition Programs
• Career Development and Training 

 

#LI-PE1 

#Field

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.

The CSV Engineer will support all CSV of Commissioning, Qualification and Verification activities for the NC Manufacturing Facility. The initial area of focus for this role will initially be in the analytical space, supporting a LIMS implementation, and the associated instrument and ancillary system integrations. Post project implementation, the Engineer will be responsible for supporting all EQV/CSV activities at the site as it transitions into routine operations.
As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

This role reports into the Site EQV/CSV Lead

Technical Skills, Knowledge, and Experience 
•    Executes the ongoing development and maintenance of the EQV/CSV/CSA/DI program for the Sanford site.
•    Executes the implementation and qualification of selected analytical system solutions and integrations.
•    Lead EQV/CSV/CSA/DI programs for various initiatives including: capital projects, site changes, technological implementations. etc.; ensuring alignment with site and global computer system validation requirements and industry practices to maintain a compliant facility.”
•    Drives CSV and integrations associated with:
o    LIMSs
o    Veeva
o    D365
o    MES / PCS / BMS / DHist
o    ValGenesis
o    Cloud
o    IT/OT
•    Once the site becomes operational, lead ongoing maintenance and continuous improvement of all qualified automation and computerized systems, ensuring continued compliance with cGMP standards, regulatory requirements, and company procedures.
Individual contributor with the opportunity to potentially lead or coordinate task teams.

Education
•    Bachelor’s degree in a technical field required.  Formal GMP and Safety training is essential.

Experience
•    At least 5 years of experience in CQV for BioPharma Manufacturing or Capital Projects.  Experience with Tech Transfer is a plus.  Background in cGMP regulations, GAMP, EHS.
•    Experience operating within a start up biopharma manufacturing facility is a plus.

Technical Skills
•    Proficient in MS Office Suite
•    Familiar with Azzure Cloud, POMSnet Aquila MES / Ignition PCS / Ignition EMS / Schneider EcoStruxure Building Operation BMS / DeltaV / Canary Axiom Data Historian / PLCs
•    Strong analytical skills to identify business requirement and to provide solutions to complex issues.
•    Strong working knowledge of regulations for computerized systems, data integrity (e.g.,
21CFRPart 11, EU Annex 11, FDA/PICS Data Integrity Guidance, GAMP5)
•    Knowledge of CSV/CSA applications and regulations

Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.
Work is 100% on-site.  This is not a hybrid or remote role.  

The anticipated salary for this position will be $106,300 to $138,800.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

 

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.

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-SH1

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:

The Director, Drug Safety Physician is the Lead of the Global Safety Team(s) to develop safety strategies to ensure patient safety and regulatory compliance for products that are in development and / or marketed. The Director, Drug Safety Physician is responsible for medical analysis of safety data, validation and confirmation of safety signals, and implementation of processes for communication and management of emerging signals and safety data to internal and external stakeholders. The Director, Drug Safety Physician, contributes to the constant improvement of the Kyowa Kirin Pharmacovigilance System to ensure the global PV strategy is in alignment with regulatory requirements and business needs.

Essential Functions:

Ensure high quality, accurate, timely medical contributions to the safety evaluation of Kyowa Kirin products by leading Global Safety Team(s) to:
•    Ensure the safe development of new products and contributions of safety are delivered in a timely and effective manner to Development teams including the identification and implementation of safety strategies to deliver Company targets for products in both development and the market.
•    Determine the safety strategy for the preparation of global regulatory submissions for Marketing Authorization approvals (e.g. North America, EMEA/ ROW, Japan and Asia Pacific) and ensure the delivery of high-quality safety documentation for those submissions.
•    Lead/ develop strategies for safety-related regulatory activities and support interpretation and authoring (in collaboration with the PV Scientist) of safety sections of documents including protocols, ICFs, IBs, clinical study reports (CSRs), Company Core Safety Information (CCSI), DSURs, PSUR, PBER, PADERRMP, REMS, Data Monitoring Committees reports, etc.
•    Lead the preparation of Benefit Risk Assessments for Kyowa Kirin products and provide appropriate support for implementation of the associated conclusions.
•    Develop proactive risk management strategies for marketed and / or investigational compounds ensuring that these are contained and implemented in appropriate strategies including Risk Management Plans. Ensure success of such activities by close liaison with cross- functional Global Development, Franchise, and labeling Teams.
•    Lead signal detection activities using data from all sources and bring medical expertise to drive Benefit Risk assessment reports, support of Company Core Data Sheets and other similar reports and actions.
•    Provide medical review and interpretation of safety data for preparation of aggregate reports and ensure consistent messaging across all such reports and documents issued for both development and post-marketing purposes.
•    Contribute to the preparation and review of pharmacovigilance documentation for internal and external use by providing medical expertise to the preparation of responses to internal and external questions relating to the safe use of Kyowa Kirin products, safety issue work up etc.
•    Ensure that updated safety profiles of Kyowa Kirin products are provided to senior management as required.
•    Represent Pharmacovigilance at internal and external meetings where issues of drug safety are to be, or may be, discussed and lead presentation of the Global Safety Team’s recommendations on safety issues to cross- functional decision-making bodies and Teams (e.g. global PV Committee, R&D Committee, Evidence Generation Committee, Label Committee, Global Development Teams, Franchise Teams, etc).
•    Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department.
•    Participate, when requested, in due diligence ensuring clear recommendations for progression to agreement.
•    Ensure that Ethics and Medical Compliance is applied within all pharmacovigilance activities.
•    To work cross functionally within project teams to meet Company objectives and to represent the Department of Pharmacovigilance in a team-oriented manner and delivering quality and timely input to meet the needs of the project team.
•    Any other activity that may reasonably be required.

Requirements:

Education
Medically qualified physician with post‑registration clinical experience. Completed specialist training and/or clinical exposure in immunology and/or haemato‑oncology is strongly preferred.

Experience
Minimum of eight (8) years’ experience in pharmacovigilance or a related area of clinical development in biotechnology or pharmaceutical industry. Demonstrated in-depth knowledge of regulatory requirements global pharmacovigilance regulatory requirements, including both pre-approval and post-marketing environments

Technical Skills
Proficient in MS Office Suite. Experience in the use and management of Drug Safety Databases and MedDRA coding.

Working Conditions

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $250,000 to $275,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

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-TT1 

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:

The Director, System leader is accountable for the strategy, governance, and value realization of all GDO systems, including Planisware and the Development Data Platform / Data Warehouse as outlined by the GDO SBO Functional Head with GDO LT. The role defines the enterprise system operating model and roadmap, ensures consistent governance and prioritization, provides strategic direction to system product and delivery leaders, and serves as the senior escalation point for cross-system risks, dependencies, and delivery issues, while overseeing execution through the GDO System significantly the Planisware SD&S & DWH Leadership (Enterprise Ecosystem: SD&S Lead for Planisware & System Oversight of the Development Data Platform).

Essential Functions:

SBO Systems Lead (GDO Enterprise Accountability): Provide senior leadership and enterprise accountability for all GDO systems supporting Global Development. (40%)
•    Alongside the SBO Global Head-Defines and own enterprise system strategy, operating model, and roadmap direction across Planisware, DDP/DWH, and other GDO systems.
•    Provide system leadership and strategic direction to the DDP/DWH Product Manager and Delivery Lead, ensuring alignment with GDO priorities and the integrated Planisware ecosystem.
•    Ensure consistency of governance, prioritization principles, and decision-making across all GDO systems.
•    Serve as the senior escalation point for system-level risks, cross-system dependencies, delivery conflicts, and governance impasses.
•    Represent GDO systems strategy, risks, and progress in executive, portfolio, and governance forums.
•    Ensure compliance with the Planisware Operating Procedure and all related governance documentation.

Planisware SD&S Lead: Provides oversight and direction to the Planisware SD&S team and is accountable for execution within the approved CMT systems development and standards framework. Responsibilities include: (60%) 
•    Leads System Development & Standards (SD&S) governance for Planisware in alignment with standard SDLC Process and enterprise strategy.
•    Performs the role of Product Manager for Planisware, translating business priorities into structured backlog, release plans, and delivery sequencing.
•    Owns Planisware LT and CMT cross-functional coordination and alignment, ensuring effective operation of FCAC, SA&S, PDM, and PPM.
•    Leads standards definition and enforcement to ensure scalable, harmonized, and compliant system processes.
•    Manages backlog prioritization and release planning in partnership with Business Process Owners, within enterprise prioritization principles.
•    Provides leadership oversight of Functional Governance & Process (FGP) and FCAC operations, DWH Lead, .
•    Ensures change management, training strategy, and adoption readiness are executed in coordination with Delivery Leads.
•    Oversees vendor governance (IFTP/Others) execution in alignment with enterprise objectives. 
•    Coordinates and Collaborates with ICT Lead.

Requirements:

Education
Bachelor’s degree in Information systems, Engineering, or closely related field. Advanced degree preferred.

Experience:
•    Minimum 10 years of experience in enterprise systems delivery or technical leadership.
•    Strong background in SDLC, validation, and testing in regulated environments.
•    Demonstrated experience delivering complex systems in global organizations.
Technical Skills
•    System configuration and integration delivery
•    Test strategy, UAT, and validation
•    Release and delivery management
•    Proficient in MS Office Suite.

The anticipated salary for this position will be $ 205,000 to $235,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

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-TT1 #Princeton #Hybrid

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.

The Director, Manufacturing will lead the KKNA North Carolina Manufacturing Operations and be a member of the Site Leadership Team (SLT).  The Director will ensure Operational Readiness for the facility start up in 2027; and deliver the Production Plan of Record subsequently as the project moves from construction, commissioning, and start up into routine operations.

This role reports into the VP, Site Leader NA Manufacturing

Responsibilities 
•    Ensures all work is carried out safely and in accordance with all applicable regulations, policies and procedures for a regulated DS manufacturing facility.  
•    As a member of the SLT, is mutually accountable for the Site Performance including delivery of site Strategies, Goals, Metrics and Reports.  In addition, as an SLT member the Director is also mutually accountable for all aspects of Talent Management including acquisition, development, retention, recognition and performance management.     
•    Leads Operational Readiness for Manufacturing in the project phase.  
•    Business Systems Owner for digital systems, ensuring delivery of all systems in accordance with program plans.  
•    Leads Operational Excellence for the site. 
•    Leads the Tech Transfer function, including MS&T.
•    Works collaboratively with other KK manufacturing sites including Takasaki (key site) and associated CDMOs.  
•    Develops and delivers operating budgets per corporate guidance.  
•    Performs other related duties as assigned.

Manufacturing Operations managers, MS&T manager, Operational Excellence Lead, plus dotted line reports for Digital systems.  

Education
BS degree in Life Sciences, Chemical or Industrial Engineering, Pharmaceutical Sciences or associated technical field.  

Experience
At least 10 years of experience in BioPharma Manufacturing in a leadership role.  

Front line supervisory experience in Pharma ops. 
Experience in Technical Transfer and / or Methods Transfer.  
Experience in managing a Manufacturing Operation’s budget.  
Involved in BioPharma Industry Organizations to understand current practices and trends in BioPharma.

Technical Skills
Knowledgeable in BioPharma Manufacturing Operations and Technical Operations Leadership. 
Strong knowledge of Safety and Sustainability Practices. 
Operational Excellence experience in LEAN and Agile manufacturing techniques.  
BioPharma business systems working knowledge including: QMS, MES, PCS, ERP, LIMs, and other standard systems used in BioPharma manufacturing. 
Cost accounting background.
Technical Process Transfer and Methods Transfer understanding.
Regulatory Compliance working knowledge.

Non-Technical Skills
Leads as a role model of our Kabegoe Principles, KK Values and Leadership Behaviors.  Leads with integrity and respect for all.  Values and promotes diversity.  

Builds strong Teams and grows Leaders.  Manages Talent effectively. 

Strong communicator and collaborator.  

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. 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 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.

Initially working in an office setting and construction site and ultimately in a biotech manufacturing site in Sanford, NC.  

Work is 100% on-site.  This is not a hybrid or remote role.  

Requires up to 20% domestic and international travel

The anticipated salary for this position will be $185,800 to $242,600.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

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-SH1

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:

The Director of Pharmacometrics will lead a team of Pharmacometricians within the Global Development Organization (GDO) and Clinical Pharmacology (CP) function. The role is intended to have a balance of direct project related activities and to support team members in the development and execution of model informed drug development (MIDD) strategies. The Director of Pharmacometrics will support continued development of appropriate workflows and systems to provide quantitative clinical pharmacology deliverables. The Director of Pharmacometrics will help develop all GDO CP members on communication of MIDD strategies and approaches to project teams. The Director of Pharmacometrics will serve to communicate with and educate leadership across the GDO organization, including those in other GDO Functions, on the value of MIDD and quantitative clinical pharmacology strategies. The Director of Pharmacometrics will also look for innovative ways to work with Kyowa Kirin organizations outside of GDO, including but not limited to Regulatory Affairs and Medical Affairs, to increase MIDD strategies throughout development and in post-marketing space.

Essential Functions:

•    Accountable for pharmacometrics deliverables supporting project teams, ensuring scientific quality, timeliness, and impact; identify and drive opportunities to advance quantitative clinical pharmacology across the organization.
•    Guide pharmacometrics strategy and ensure high-quality preparation of pharmacometric components for scientific reports, regulatory submissions, and responses to health authority inquiries.
•    Provide scientific and technical leadership to pharmacometrics staff, ensuring excellence in modeling approaches and effective communication at all organizational levels.
•    Support clear and impactful communication of pharmacometric and clinical pharmacology results to diverse internal and external audiences.
•    Collaborate with GDO Clinical Pharmacology colleagues and cross-functional partners to improve efficiency, alignment, and innovation across drug development initiatives.
•    Advance Model-Informed Drug Development (MIDD) standards by incorporating best practices from the scientific community to continuously improve workflows, processes, and analytical rigor.
•    Establish and implement workflows, tools, and training programs, leveraging internal and external resources to strengthen pharmacometrics capabilities within GDO Clinical Pharmacology, with particular focus on developing Pharmacometrics Leads.
•    Develop and maintain a network of preferred external pharmacometrics experts to support advanced or specialized analyses as needed.
•    Promote scientific visibility through conference presentations and peer-reviewed publications, ensuring dissemination of insights and research outcomes to the broader scientific community.

Requirements:

Education
PhD preferred with specialty training in Pharmacometrics, appropriate MS or PharmD also applicable

Experience
•    Minimum 10 years of pharmaceutical industry experience gained in pharmacometrics / quantitative clinical pharmacology is required. 
•    The understanding and ability to communicate and apply MIDD strategies to drug development. 
•    Understanding of pharmacometrics contributions for successful clinical development of small molecules, biologics, and alternative therapies.
•    Experience in the successful use of MIDD to support drug development decision making
•    Ability to conduct hands-on modeling and simulation using appropriate quantitative tools in a regulated drug development environment, considered expert in field 
•    Experience in the preparation of strategic regulatory documents including reports, summary documents, and response to information requests.
•    Leadership of a team with various backgrounds and skills in pharmacometrics.
•    Experience of developing individuals pharmacometric and communication skills and talents  

Technical Skills
Proficient in MS Office Suite.
Demonstrated proficiency with pharmacometric software tools for non-linear mixed effects modeling, data manipulation, physiologically based pharmacology, and systems pharmacology modeling, such as: Julia/Pumas app, R-studio, NONMEM.

The anticipated salary for this position will be $230,000 to $250,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Discretionary Profit Share
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

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-TT1 #Hybrid #Princeton

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.

Job Summary:

The Executive Administrator is a critical role responsible for supporting Canadian operations and projects within the Canadian affiliate. This position will play a key role within a highly matrixed environment by supporting the General Manager (GM) and Canadian Leadership Team (LT) members in customer facing activities and other projects.

Essential Functions:

Project Coordinator Duties:
•    Support Canadian LT projects. Responsible for project management and execution of operational and logistical processes for customer-facing activities. including submission and management of requests for vendor onboarding, procurement and related payments.
•    Draft, proofread, and format templates, documents and communications in support of customer facing activities and other Canadian projects, maintaining a high standard of accuracy and professionalism.
•    Plan and coordinate meetings, both on-site and off-site, involving staff members, by scheduling meetings, reserving conference rooms, preparing and distributing meeting materials, coordinating audio-visual equipment and catering needs, as well as formatting documents into final form.
•    Coordinate various cross functional project activities, conducting needs assessment and prioritization, ensuring alignment with project objectives and timelines.
•    Maintain regular communication with the GM & LT, provide updates on task statuses and discuss priorities and other pertinent matters.
•    Execute project directives by liaising with multiple departments, including interfacing with other KK North America functional groups, outside partners and other stakeholders, to foster relationships and facilitate effective communication and issue resolution.
•    Serve as a representative of assigned projects in technical and administrative capacities at external events such as meetings, conferences, and vendor engagements as required.
•    Other duties as assigned.

Executive Administrator Duties:
•    Responsible for managing Canadian office operations and logistics, including telephone calls, correspondence, and general inquiries for the Canadian office, ensuring triage of matters to the appropriate department and staff
•    Provide comprehensive administrative and coordinator support to the GM and LT members ensuring seamless operations and efficient workflow.
•    Manage GM’s calendar, proactively bringing attention to crucial matters and ensuring timely responses to emails and other communications.
•    Generate, edit and format presentations to be used in internal and externals meetings 
•    Attend meetings as required, preparing and maintaining detailed meeting notes to capture key discussions and action items for LT and other meetings
•    Effectively manage documents across various software programs, demonstrating proficiency with different technologies and a willingness to adapt and learn new tools as necessary.
•    Act as first point of contact for internal and external communications addressed to the GM as needed. Handle general inquiries via telephone and email for the department(s), addressing routine and non-routine questions promptly and identifying urgent activities for timely resolution.

Requirements:

Education
Bachelor’s or graduate degrees in Business Administration, Management or other disciplines required. Project Management Professional (PMP) certification a plus.

Experience
Minimum of four years’ experience in project management or administrative support to Leadership Teams, preferably in the life sciences industry. Experience in supporting executive teams is a plus. 

Technical Skills
•    Advanced proficiency with Microsoft Office Suite (MS Word, MS Excel, and MS PowerPoint).
•    Advanced proficiency with project management software, e.g. MS Project Ability to prioritize tasks effectively, manage multiple deadlines, and adapt to changing priorities in a fast-paced environment.
•    Discretion in handling confidential/proprietary information.
•    Demonstrated ability to work with a diverse set of communities – researchers, administrators, technical staff, and programmers, to solve problems and build consensus.

Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethics are 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.

The anticipated salary for this position will be $79,000 CAD to $95,000 CAD.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

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.

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.

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.

We are currently seeking an MBA Intern to join our launch team. As a Graduate Marketing Intern, you will work closely with the Marketing Department and the areas of the business that we collaborate with. This candidate should have an interest in obtaining practical experience in business strategy, market research, and marketing in the pharmaceutical industry. This position is a paid, temporary internship eligible to students currently enrolled or recently graduated from a US based MBA program within a commutable distance of Princeton, NJ. This role is a hybrid role with a minimum of two days in person at the Princeton office.

Key Responsibilities:

Working closely with the Marketing Team on assigned tasks. They may include:

• Market Analysis and Product Strategy:
• Learn and understand HCP and Patient marketing needs
• Help analyze clinical profiles, strengths, and weaknesses of current market products/ competitive landscape
• Evaluate early competitive messaging, positioning, and physician perspectives for expected entrant(s)
• Contribute to pull through tactics to strengthen positioning of own product
• Understand current market trends to participate in key program development in preparation for product launch
• Learn about current marketing challenges and work on strategic projects that mitigate identified challenges
• Identify leverage points in marketing initiatives and provide recommendations
• Apply critical thinking skills to solve structured and unstructured problems

• Omni-Channel Marketing:
• Evaluate marketing channels for effectiveness in reaching healthcare professionals and patients while informing the sales team
• Work with marketing, digital, analytics teams, and agencies to build educational content for disease state and product
• Customize content and messaging hierarchy for different audiences (Patients, Nurses, Physicians)
• Test user experience and make recommendations on improvement of digital assets
• Monitor execution through multiple channels and build reports on performance metrics

• Launch Readiness Activities
  • Help to develop key performance indicators and dashboards to measure future launch performance
  • Support launch readiness activities and communications for upcoming product launch
  • Facilitate meetings and logistics for Launch Readiness Team

Qualifications/Requirements:

• This position requires candidates to be a current student  or recent graduate of a US based MBA program with a concentration in Marketing or related area.
• Candidates are required to live within a commutable distance of Princeton, NJ.
• Interns are required to be able to work from May 26^th, 2026 to August 19^th, 2026
• Interest in a pharmaceutical career with high intellectual curiosity and desire to learn and grow
• The ability to work a hybrid schedule is required
• Prior internship or co-op experience is preferred
• This position requires that candidates be able to work in the United States on a permanent and on-going basis without sponsorship

The anticipated salary for this position will be $27.00 to $29.00.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

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.