Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology, and CNS/movement disorders. The North American organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can profoundly impact patient lives.
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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.
Summary:
The Manager, ICT Delivery plays a critical role in delivery of complex technology projects and IT services. They combine strategic planning with tactical execution to align team output with broader organizational goals, managing everything from initial scoping to final deployment and post-launch support. They ensure that digital initiatives are executed efficiently, securely and in alignment with GxP standards. They exhibit strong delivery leadership with a deep appreciation for the complexities of the pharmaceutical environment.
Essential Functions:
• Participate in project planning, execution, risk management, and quality assurance across multiple concurrent initiatives.
• Ensure solutions meet regulatory and data privacy requirements, including GxP, 21 CFR Part 11, HIPPA, GDPR and data integrity standards.
• Apply and follow appropriate delivery methodologies (Agile, Waterfall, hybrid) based on project needs and compliance considerations.
• Collaborate with business, technical teams and vendors to ensure accurate translation of business requirements into technical solutions.
• Assume accountability throughout all phases of system development lifecycle from ideation and planning through production support and troubleshooting.
Additional activities may include, but are not limited to:
• IT Project Oversight - Review project timelines, milestones, risks and budget to ensure delivery stays on track.
• Stakeholder Communication & Alignment - Manage expectations, clarify priorities and drive compromise between business needs and technical constraints.
• SDLC Compliance – Ensure all system changes follow appropriate lifecycle processes; review documentation for accuracy, completeness, and audit readiness.
• Issue Resolution & Operational Support – Assist in the triage of issues / incidents that impact production systems or project timelines.
Requirements:
Education
Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required
Experience
At least 5 years’ experience delivering IT projects within a regulated industry, ideally pharmaceuticals or life sciences; Familiarity with multiple functional domains (e.g. Quality, Regulatory, Medical, Commercial and/or Clinical); Knowledge of GxP compliance, validation practices and regulated system requirements; Experience with large-scale, global implementations; Experience with enterprise technologies such as Veeva Vault, Salesforce.com, Microsoft Dynamics
Technical Skills
Proficient in MS Office Suite.
Working Conditions:
Requires up to 10% domestic and international travel
The anticipated salary for this position will be $121,000 to $156,800. 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:
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.
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
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Apply to Kyowa Kirin North AmericaShare this job
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:
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.
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
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
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, Site Budget Management provides strategic and operational leadership across assigned segments of Kyowa Kirin’s global clinical study portfolio. This role bridges study-level execution and enterprise strategy by overseeing budget governance, forecasting methodology, financial risk management, and process optimization initiatives.
The Associate Director drives consistency in budget development, negotiation parameters, and payment oversight while contributing to short and mid-range portfolio planning. This position ensures financial integrity, scalability, and alignment with global FMV standards across all new and ongoing studies within scope.
Essential Functions:
Portfolio Oversight and Financial Planning
• Provide oversight across multiple global studies within assigned therapeutic areas or portfolio segments.
• Partner with the Director to support long range financial planning across the clinical pipeline.
• Review and validate study-level forecasts to ensure portfolio alignment.
• Identify cross-study cost trends, variance drivers, and financial risk indicators.
• Support accrual accuracy and forecast predictability.
Global Budget Governance and FMV Oversight
• Ensure consistent application of FMV methodology across assigned studies.
• Validate high, mid, and low negotiation parameters.
• Review CRO-developed budgets for compliance and alignment to governance standards.
• Support regional alignment including US, EU, and Japan point system methodologies.
• Maintain audit-ready documentation and financial traceability.
Budget Development and Negotiation Leadership
• Oversee study-level budget build, review, and approval processes.
• Provide negotiation strategy guidance to Senior Managers and CRO analysts.
• Escalate deviations outside approved financial thresholds.
• Ensure budget alignment with protocol scope and operational effort.
• Review amendment-related financial impacts.
Process Optimization and Standardization
• Identify opportunities to improve global budget workflows.
• Standardize templates, parameter frameworks, and tracking tools.
• Reduce negotiation cycle times through structured governance.
• Contribute to automation and systems integration initiatives.
• Develop KPIs to measure performance, cycle time, and cost containment.
Site Payment and Vendor Oversight
• Provide financial oversight of site payment execution across assigned portfolio.
• Monitor vendor and CRO payment performance.
• Review reconciliation reporting and identify discrepancies.
• Serve as escalation point for complex payment-related issues.
• Ensure payment schedules align with approved budgets and contractual terms.
Financial Analytics and Executive Reporting
• Prepare consolidated financial dashboards for assigned portfolio segment.
• Provide variance analysis and risk summaries.
• Support executive reporting with clear financial narratives.
• Conduct scenario modeling to evaluate financial impact of amendments, enrollment changes, or country mix adjustments.
Leadership and Organizational Support
• Directly manage Site Budget Managers and Senior Managers as assigned.
• Provide strategic oversight to CRO budget analysts within outsourced model.
• Mentor team members on forecasting discipline and governance expectations.
• Support resource demand planning based on study complexity and portfolio growth.
Requirements:
Education
Bachelor’s degree in finance, Business Administration, Accounting, Life Sciences, or related discipline required.
Advanced degree or professional certification preferred
Experience
• Minimum seven (7) years of experience in clinical trial budgeting, site financial management, or global clinical business operations.
• Demonstrated experience managing global site budgets.
• Experience within an outsourced CRO operating model.
• Experience supporting portfolio forecasting and financial analytics.
• Experience leading or mentoring budget professionals.
• Working knowledge of Japan FMV methodology preferred.
Technical Skills
• Advanced Excel and financial modeling capability.
• Expertise in FMV benchmarking tools.
• Experience with GrantPlan or equivalent systems.
• Familiarity with CTMS, reporting platforms, and payment tracking systems.
• Strong analytical and risk assessment capability.
Core Competencies
• Strategic thinking with operational execution strength
• Financial governance discipline
• Process improvement mindset
• Executive communication capability
• Risk identification and mitigation
• Structured decision making
• Cross-functional collaboration
• High integrity and compliance orientation
Working Conditions:
• Requires up to 10%-15% domestic and international travel
• Availability to support global teams across multiple time zones, including periodic late evening calls.
The anticipated salary for this position will be $175,000 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:
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.
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 #Remote #Princeton
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
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 Senior Director, GRA Development & Product Strategy Team Lead is responsible for the developing and implementing regulatory strategies, while leading people amd managing global projects. This role oversees a team of Global Regulatory Leads (GRL) supporting global products and may serve as a Regional Regulatory Lead (RRL) based on business needs.
Essential Functions:
• Define and drive global regulatory strategies for all products within the assigned disease area, ensuring alignment with enterprise objectives and maximizing product value.
• Lead and develop a team of Global Regulatory Leads (GRLs), setting direction, building capabilities, and fostering a high-performance, accountable culture.
• Shape and integrate regulatory strategy into global product development and lifecycle plans in close partnership with cross-functional stakeholders.
• Oversee and ensure execution of regulatory strategies, including global submissions, approvals, and post-approval activities across assigned products and projects.
• Direct and represent the organization in interactions with health authorities, including leading negotiations and overseeing agency meeting strategy and execution.
• Guide and approve global regulatory submission plans, including marketing applications, labeling (e.g., CCDS), and key lifecycle deliverables.
• Manage and coordinate regulatory activities, timelines, and deliverables across internal teams and external partners, ensuring alignment and on-time execution.
• Ensure compliance with global regulatory requirements, internal policies, and GxP standards, including support for inspections, audits, and governance processes.
• Assess and communicate regulatory risks, emerging trends, and competitive intelligence, escalating issues and recommending mitigation strategies as appropriate.
• Drive operational excellence by leading process improvements, standardization efforts (e.g., SOPs/WIs), and adoption of best practices across Regulatory Affairs.
• Oversee external partnerships and due diligence activities, including vendor selection, alliance management, and regulatory support for business development transactions.
• Contribute to organizational leadership, including participation in RA Functional Teams (RAFTs), budget oversight, and fostering collaboration across Regulatory Affairs and the broader organization.
• Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet (CCDS) development and alignment with regional labeling requirements.
• Allocate and optimize regulatory resources across the portfolio, ensuring effective prioritization and support for key business objectives.
• Recruit and build organizational capability by leading talent acquisition, succession planning, and ongoing training initiatives within the regulatory function.
• Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles, and the Global Regulatory Affairs Vision.
Requirements:
Education
Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline required. Advanced degree (e.g., MS, PhD, PharmD, MBA) is preferred but not required; relevant industry experience may be considered in lieu of advanced education.
Experience
• Minimum 12+ years extensive regulatory affairs experience within the pharmaceutical, biotechnology, or related industry, including global development and lifecycle management, with a focus on bone and mineral disease areas.
• Proven leadership experience, including managing and developing high-performing regulatory teams and/or leading through other leaders (e.g., GRLs)
• Demonstrated success in developing and executing global regulatory strategies across multiple regions and product stages (development through post-approval)
• Significant experience interacting with health authorities, including leading regulatory agency meetings and negotiations
• Cross-functional leadership experience, with a strong track record of influencing stakeholders and driving alignment across complex, matrixed organizations
• Experience supporting business development activities, including regulatory due diligence for in-licensing, out-licensing, or partnerships Strong collaboration across cross-functional teams including regulatory affairs, government affairs, clinical, legal, and R&D.
Technical Skills
• Deep knowledge of global regulatory frameworks and guidelines, including major markets (e.g., FDA, EMA, ICH,PMDA) and their application to drug development and lifecycle management
• Expertise in regulatory submissions and approvals, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval variations
• Strong understanding of global labeling requirements, including development and maintenance of Company Core Data Sheets (CCDS)
• Advanced regulatory strategy development and risk management skills, with the ability to anticipate challenges and drive solutions
• Familiarity with GxP requirements and regulatory compliance standards, including inspection and audit readiness
• Proficiency in regulatory systems, tools, and document management platforms used for submissions, tracking, and compliance
• Strong organizational and project management skills with the ability to manage multiple initiatives simultaneously.
• Exceptional communication and influencing skills, with the ability to clearly articulate complex regulatory strategies, risks, and requirements to diverse audiences, including health authorities, senior leadership, and cross-functional teams, to drive alignment and informed decision-making.
• Strong proficiency MS Office Suite.
Working Conditions:
Requires up to domestic and international travel.
The anticipated salary for this position will be $265,000-$285,000. 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:
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.
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
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
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, Clinical Science (non-hemato-oncology) is a vital position in our growing global organization. As part of the Clinical Science group, this person is a key member of multi-disciplinary project teams responsible for the achievement of milestones (e.g., IND, FIH, POC, EOP2, NDA) for development programs. It is expected for this role to exercise leadership in the scientific discussion in project teams from the clinical perspective, diving deeply into the science of her/his assigned program(s), and perform the role of a subject matter expert for the program(s). He/she will play an active role in the creation of regulatory documents (e.g., BB, IND), study protocols, and clinical development plans for new and/or launched products, including lifecycle management. He/she will be responsible for establishing and maintaining KOL relationships.
Essential Functions:
• Serve as leading voice on clinical matters as Clinical Science representative on assigned project team(s), based on firm understanding of given disease area(s) and of clinical development processes, especially in the US and Europe
• Lead in the formulation of clinical development strategies, in collaboration with related functions, and create clinical development plans, accordingly
• Lead in the formulation of clinical trial protocols with sufficient feasibility and high probability of success, based on significant expertise in new drug development
• Lead in the development of written material for clinical sections of key regulatory submissions; work closely with Regulatory in the process of preparing these submissions and ensure compliance with local regulatory requirements and standards throughout the course of clinical trials.
• Work closely with cross-functional teams, including Regulatory, Marketing, and Quality to support clinical trial design and execution, regulatory submissions, and launch-related activities.
• Provide input from the clinical perspective to the formulation of Target Product Profiles.
• Analyze safety and efficacy findings from clinical studies; participate in inter-disciplinary team meetings, as required
• Support required safety evaluations for clinical studies, e.g. AE assessment, as needed.
• Create and maintain good relationships with clinical investigators and relevant Key Opinion Leaders; identify physicians with potential to serve as strong investigators for clinical studies
• Attend relevant scientific meetings to strengthen competency in assigned field(s) and to gain awareness of research activities underway and activities of competitors
• Serve as an author and lead in the preparation of review articles and conference presentations, relating to assigned clinical trial(s)
• Support business development, as needed, in due diligence efforts of new in-licensing opportunities (or other topics).
• Foster and contribute to collaborative environment that seeks to encourage innovation, strengthen scientific understanding among team members, and enhance professional development for all.
• Perform other duties, as required.
Requirements:
Education
MD (or equivalent), PharmD, PhD in life sciences or related field; applicable R&D experience may also be considered.
Experience
• Minimum 10 years of relevant clinical research experience with at least 5 years in clinical development role
• Authorship and review of clinical development plans, clinical study protocols, briefing books, IBs, SAPs, and CSRs
• Significant experience and ability to work effectively with external partners, including physicians and vendors
• Preferred experience: leadership role in large, late-stage, global outcomes trials; background in Bone & Mineral or Rare Disease trials
Technical Skills
• Strong scientific background with good understanding of drug development process
• Good leadership skills, highly motivated, great attention to detail, ability to work in complex and changing situations, excellent problem-solving skills
• Broad level of interpersonal skills and flexibility; cultural sensitivity and ability to develop consensus within matrix structure of a multinational organization
• Excellent written and oral communication skills
• Good project management skills; able to organize and prioritize multiple activities
• Proficient in MS Office Suite, relevant software applications, using templates, and other electronic formats
• Ability to think analytically (in terms of both strategy and tactics) and simultaneously consider scientific, medical, and business aspects of projects
Working Conditions:
Requires up to 15% domestic and international travel
The anticipated salary for this position will be $225,000 to $285,000. 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:
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.
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
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
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 $175,000 to $190,000. 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:
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.
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
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
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 Specialist, Bioanalytical, Translational Research supports multiple pharmaceutical development programs by managing clinical sample use and disposition for biomarker testing, coordinating with external vendors, and providing data analysis support to biomarker teams. This role also facilitates collaboration with project teams and contributes to related clinical trial activities as needed.
Essential Functions:
• Implement and coordinate with other functional areas to institute processes for clinical sample management, from informed consent to data generation, including biobanking processes.
• Support biomarker teams in managing biomarker activities, such as organizing and analysis of biomarker data, conducting biomarker data verification and quality control, etc.
• Assist in coordinating and overseeing vendors for biomarker and bioanalytical assays, including selection, contracting, performance monitoring, and collaboration with colleagues across regions (e.g., Japan) and functions (Clinical Operations, Biometrics, Medical Sciences). Represent Translational Research on study teams.
• Maintain and keep bioanalytical assay and clinical study-related files and documents organized and archived in the trial master file (TMF).
• Ensure regulatory and procedural compliance by following applicable standards, guidelines, and regulations for patient sample handling and biomarker data management.
• Contribute to process improvement and innovation by developing optimized methods for sample handling, data management, and integration of results into the design of new clinical studies.
• Develop and maintain SOPs and related documents (manuals, work instructions) for sample acquisition, handling, and use.
• Collaborate across functions to support departmental and company goals, including contributions to study action plans and broader program objectives.
Requirements:
Education:
Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Pharmacology or closely related discipline. Masters degree a plus.
Experience:
• Minimum 2 years of experience in bioanalytical, translational research, or clinical research settings, preferably in the pharmaceutical or biotechnology industry.
• Exposure to handling and processing clinical samples, including sample tracking and storage.
• Hands-on experience with biomarker assays, data analysis, or quality control activities.
• Participation in cross-functional project teams or collaborative research initiatives.
• Experience interacting with external vendors or laboratory partners is a plus.
Technical Skills
• Knowledge of bioanalytical and biomarker assay principles, sample handling, and biobanking processes.
• Familiarity with clinical sample documentation and regulatory requirements (e.g., GCP, SOPs, TMF).
• Proficiency in basic data analysis and reporting using standard software tools (e.g., Excel, GraphPad, or equivalent).
• Strong organizational skills with the ability to track multiple samples, datasets, and projects.
• Effective written and verbal communication skills for scientific documentation and cross-functional collaboration.
• Ability to follow protocols, standard operating procedures, and quality guidelines with attention to detail.
• Familiarity with scientific analytical software (JMP, R, Etc)
• Proficient in MS Office Suite
Working Conditions:
Requires up to 5% domestic and international travel
The anticipated salary for this position will be $90,000 to $105,000. 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:
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.
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
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
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 Manager, R&D QA, Global Audits, Inspections and R&D Quality is responsible for managing Quality Assurance systems, processes and conducting internal and external audits and reviews, training, and reporting according to KK standards. The R&D QA Manager will support the QA program to assure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The R&D QA Manager will collaborate and provide key quality input to KK’s R&D function.
Essential Functions:
• Serve as key point of contact for GCP/GLP quality issues reported by KK staff and provides ongoing feedback to management on potential quality-related risks. Involvement in clinical trials includes, but is not limited to, independent review and approval of deviations and CAPAs, GCP guidance, and quality agreement preparation.
• Perform and report assigned GCP/GLP audits of KK studies, including clinical investigator sites, vendors/CROs, internal systems/processes, and clinical data/documents, as applicable.
• Prepare timely, high-quality audit reports; evaluate audit responses; and oversee CAPA development, adequacy, implementation, and tracking in accordance with KK standards.
• Maintain expert-level knowledge of global GCP/GLP regulations and industry expectations. Serve as a subject matter expert to KK staff, provide interpretation of regulatory requirements, and actively contribute to the company’s Regulatory Intelligence program.
• Design and deliver GCP training to KK staff to enhance compliance awareness, inspection readiness, and quality culture.
• Support continuous improvement initiatives; develop, revise, and administer SOPs and controlled documents; and ensure effective maintenance within quality document management systems.
• Participates in Health Authority inspection activities for domestic and international projects (as applicable).
• Provides input to the annual risk-based audit plan, schedule and execution of audits based on changing business environment and interaction with cross-functional teams.
• Undertake other QA-related duties as directed by the supervisor to support departmental and organizational objectives.
Requirements:
Education
Bachelor’s degree in Life Science or closely related scientific discipline (e.g., Pharmacy, Chemistry, Microbiology, Biology, or Pharmaceutical Sciences) required
Experience
• Minimum three (3) experience in drug development in GCP/GLP Quality Assurance, including hands-on experience in auditing, CAPA management, and deviation review.
• Demonstrated knowledge of global regulatory requirements, including EMA, FDA, MHRA, ICH, and other applicable standards, with proven ability to interpret and apply them in operational settings.
• Experience supporting Health Authority inspections, including preparation, participation, and follow-up actions.
• Proven track record in developing and implementing risk-based audit plans, SOPs, and quality systems, with experience in quality document management.
• Experience in training and mentoring staff on GCP/GLP compliance and fostering a culture of quality.
• Exposure to global, cross-functional collaboration with clinical, regulatory, and operational teams on QA-related matters.
• Prior involvement in vendor/CRO management, clinical site audits, and quality agreement development is highly desirable.
Technical Skills
• Experience with Veeva or other electronic Quality Management Systems (eQMS) for document control, audit tracking, and CAPA management.
• Ability to generate comprehensive audit reports and perform trend analysis.
• Familiarity with regulatory intelligence tools and systems to track evolving GCP/GLP requirements.
• Strong skills in risk assessment and quality metrics reporting.
• Excellent written and verbal communication skills for interacting with internal teams and external regulatory authorities.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook) for reporting, data analysis, and presentations.
Working Conditions:
Requires up to 20% domestic and international travel
The anticipated salary for this position will be $135,000 to $150,000. 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:
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.
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
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
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 Veeva Vault Architect serves as the technical and strategic leader for designing, implementing and optimizing Veeva Vault solutions across the global organization. This role ensures that all Vault applications align with business objectives, regulatory requirements, and enterprise architecture standards. The architect collaborates closely with business stakeholders, IT teams and implementation / support partners to deliver scalable, compliant and high performing Vault-based solutions.
Essential Functions:
Solution Architecture & Design
• Develop end to end architecture for Veeva Vault applications (e.g., Quality, RIM, Medical, Commercial).
• Interpret business requirements into scalable, secure and compliant Vault configurations.
• Define data models, object structures, workflows, lifecycle states and security models.
• Establish integration patterns between Vault and other enterprise systems (ERP, LMS, MDM, LIMS, etc.).
• Create architectural standards, design documents and technical specifications.
Platform Leadership
• Serve as the subject matter expert for Veeva Vault capabilities, limitations and best practices.
• Guide configuration teams on Vault objects, metadata, workflows and automation.
• Familiarity with domain level configuration and best practices.
• Evaluate new Vault features and releases, advising on adoption and impact.
• Ensure alignment with GxP, 21 CFR Part 11, Annex 11, and other regulatory frameworks.
Implementation & Delivery
• Lead technical workstreams during Vault implementations, migrations and enhancements.
• Oversee data migration strategies, mapping, cleansing and validation.
• Support test planning, execution, and defect resolution for configuration and integrations.
• Partner with project managers to ensure delivery timelines and quality standards are met.
Integration & Data Management
• Architect and oversee integrations using native Veeva Vault Integrations, Veeva APIs, Vault Loader and middleware tools across both Vault and other applications.
• Ensure adherence to data governance, master data strategies and cross system data flows.
• Ensure data integrity, auditability, and traceability across the Vault ecosystem.
Stakeholder Collaboration
• Work with business process owners to understand needs and translate them into technical solutions.
• Collaborate with QA/SA, Compliance, Data Privacy and Validation teams to ensure system readiness.
• Provide technical guidance to internal teams and external implementation partners.
Operational Excellence
• Establish monitoring, performance optimization and support frameworks.
• Develop documentation, SOPs and knowledge transfer materials.
• Support ongoing enhancements, change requests and continuous improvement initiatives.
Requirements:
Education
Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required. Veeva Vault certification(s) preferred.
Technical Skills
• 8+ years of experience in the configuration, implementation, support and operations of Veeva Vault-based solutions.
• Proven expertise across multiple functional domains (Quality, Regulatory, Medical, Commercial and/or Clinical).
• Hands-on experience with Veeva APIs, integration patterns and data migration tools.
• Knowledge of GxP compliance, validation practices and regulated system requirements.
• Experience with large-scale, global implementations.
• Experience with middleware platforms (e.g., MuleSoft, Informatica), Master Data Management concepts and solutions preferred.
Working Conditions:
Requires up to 10 % domestic and international travel.
Willingness to work in a global environment with the ability to adapt to diverse cultural norms, including different communication styles, time zones, holiday schedules, and management approaches.
The anticipated salary for this position will be $185,000 to $200,000. 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:
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.
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
Ready to apply?
Apply to Kyowa Kirin North AmericaShare this job
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, Regulatory Affairs, Advertising and Promotion Compliance will independently review, approve, and monitor product advertising and promotional labeling material for an assigned product to ensure compliance with US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of FDA Form 2253 submissions and any requests for advisory comment submissions to FDA's Office of Prescription Drug Promotion (OPDP) as well as submissions to PAAB for promotional materials in Canada, as applicable.
Essential Functions:
• The Associate Director is responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications as well as pipeline and non-promotional communications.
• Provides guidance and input for assigned development products reflective of promotional considerations, including assessment of potential labeling claims.
• Serves as Promotional Review Committee (PRC) chair and as the primary regulatory reviewer of advertising, promotions, and other related materials for assigned product to ensure compliance with applicable FDA/Health Canada laws, regulations, and guidance.
• Works collaboratively with cross-functional partners, including Legal and Medical as part of PRC. Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating, and managing business risks.
• Serves as the regulatory reviewer for the Medical Review Process (MRC) for assigned product(s).
• Provides direction and works collaboratively to ensure that changes in US Prescribing Information and Canadian Product Monograph are reflected in current promotions and advertising
• Continually assesses the advertising and promotion related
process to enhance efficiencies and compliance.
• Collaborates in cross-functional efforts to develop, update, and implement policies, procedures and guidelines related to Regulatory Advertising and Promotion Compliance.
• Primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for assigned products.
• Monitors US and Canadian regulatory promotional environment and stays abreast of all relevant regulatory and industry changes and updates related to FDA and Health Canada guidance, warning letters, enforcement actions and regulations; and communicate to appropriate internal and external personnel in a timely manner, highlighting the implications of the changes
• Ensures the maintenance of paper and electronic records of all submissions and communications with OPDP, and any supporting documentation
• Provide relevant regulatory compliance training to staff and cross-functional partners from a regulatory perspective.
Requirements:
Education
Bachelor’s degree in life science or closely related discipline. Advance degree preferred (Pharm.D., Phd, M.S, JD)
Experience
• Minimum seven (7) years of progressive experience in the pharmaceutical or biotechnology industry, specifically in Regulatory Affairs with a focus on Advertising and Promotion (Ad/Promo).
• Proven track record as the primary regulatory reviewer for promotional and non-promotional materials across various therapeutic areas, ensuring compliance with FDA regulations, industry guidelines (e.g., OPDP, PhRMA), and internal policies.
• Strong experience in leading and managing Regulatory review processes within cross-functional Medical, Legal, and Regulatory (MLR) teams for both consumer and professional marketing materials.
• Familiarity with launch planning, including pre-approval communications, disease awareness campaigns, and launch materials.
• Experience with training Commercial and cross-functional teams on promotional compliance principles, regulatory changes, and industry best practices.
• Preferred, but not required, experience with reviewing promotional and non-promotional communications in Canada to be compliant with Health Canada regulations.
Technical Skills
• Thorough knowledge of applicable regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments in the US
• Understanding of clinical study design and statistical analyses in assessment of promotional claims
• Excellent written, verbal, and presentation skills, with the ability to communicate effectively across all levels of the organization.
• Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.
• Experience with Veeva, SharePoint and Box
Working Conditions:
Requires up to 10% domestic and international travel
The anticipated salary for this position will be $____ to $____. 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:
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.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
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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:
We are seeking a Security Operations Specialist to join our Global Information Security team. This role will serve as the regional lead for North America security operations and OT/ICS security, responsible for incident response, monitoring, and cyber defense across IT and manufacturing environments. The ideal candidate will have strong experience in SOC operations, OT cybersecurity, and regulated industries, with the ability to respond under pressure while also driving continuous improvement.
Essential Functions:
• Lead incident response for North America, coordinating with the global SOC for escalations, investigations, and recovery.
• Manage monitoring solutions to ensure high-quality visibility across IT, cloud, and OT environments.
• Own OT/ICS cybersecurity strategy in partnership with manufacturing, infrastructure, and plant leadership, securing SCADA, PLCs, and lab systems.
• Vendor management for proactive threat hunting, pen testing and forensic analysis.
• Lead remediation activities for both IT and OT environments.
• Drive regional execution of global SOC playbooks, escalation models, and threat intelligence integration.
• Develop and maintain operational security runbooks and ensure continuous improvement of detection and response capabilities.
• Partner with IT, R&D, and Manufacturing to enforce regulatory compliance across GxP, HIPAA, and FDA-controlled systems.
Requirements:
Education
Bachelor’s degree in Information Security, Computer Science, or related field required; Advanced training in OT/ICS security preferred.
Certifications Required: CISSP
Certifications Preferred: GICSP, GRID, or other OT-focused certifications
Experience:
At least 5 years in cybersecurity operations, with demonstrated experience in SOC or incident response leadership; Strong hands on experience with OT/ICS environments in pharma, biotech, manufacturing, or critical infrastructure; Expertise in SIEM, SOAR, forensic tools, and threat detection engineering; Knowledge of OT security frameworks (ISA/IEC 62443, NIST CSF) and pharmaceutical regulations (GxP, HIPAA, 21 CFR Part 11).
Technical Skills
• Expertise in Security Operations and Incident Response, including triage, investigation, containment, and recovery across IT, cloud, and OT environments.
• Hands-on experience with SOC technologies such as SIEM, SOAR, EDR/XDR, and forensic analysis platforms.
• Strong background in OT/ICS cybersecurity, including SCADA, PLCs, and lab systems, with application of frameworks such as ISA/IEC 62443 and NIST CSF.
• Knowledge of threat detection engineering, use-case development, and integration of threat intelligence into monitoring workflows.
• Proficiency in forensic tools and malware analysis to support root-cause identification and post-incident review.
• Understanding of regulatory compliance requirements including GxP, HIPAA, and 21 CFR Part 11, as they apply to manufacturing and research systems.
• Experience collaborating on vulnerability management, patching, and remediation across IT and OT environments.
Working Conditions:
Requires up to 10 % domestic and international travel
The anticipated salary for this position will be $115,000 to $130,000. 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:
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.
Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.
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Ready to apply?
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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.
Summary:
The Associate Director, ERP Functional & Solution Architect, ICT role will be responsible for overseeing MS D365 Enterprise Resource Planning (ERP) within the organization. Crucial role in implementing ERP specific business process improvements and enhancements within the organization and ensuring the system's optimal performance and functionality. Perform the planning, design, configuration, customization, and implementation of MS D365/ERP modules and functionalities, ensuring seamless integration with existing systems, ensuring compliance with industry standards, security protocols, and regulatory requirements. The ERP Functional Architect, Associate Director, ICT role will also serve as a business process analyst aligned with enterprise (i.e., SCM, MFG, Quality) and Corporate Functions (i.e., Finance, HR, Legal, Compliance, Procurement) ensuring successful technical solution development and delivery.
Essential Functions:
The D365 ERP F&O Functional Architect is responsible for the end-to-end functional design, configuration, and optimization of Microsoft Dynamics 365 Finance & Operations to support business operations across Finance, Procurement, Supply Chain, Manufacturing, Quality, and related business functions. The architect will partner with business stakeholders, technical teams, and implementation partners to ensure that the solution is aligned with corporate strategy, compliant with GxP/GAMP 5 standards (where applicable), and scalable for future business growth.
1. Solution Architecture & Design
• Lead the functional design and architecture of the D365 F&O solution across key modules (Finance, Supply Chain, Manufacturing, Procurement, Inventory, Quality, etc.).
• Translate complex business requirements into clear, scalable, and compliant functional solutions.
• Emphasizes proactive, holistic leadership in solution architecture.
• Focuses on aligning solutions with business goals, value streams, and enterprise architecture governance.
• Define data flows, integrations, and system interactions between D365 and other enterprise systems & interfaces (e.g., LIMS, MES, 3PL Partners, External Finance Systems, and Cloud systems).
• Ensure alignment with Microsoft’s Dynamics 365 roadmap and best practices.
2. Implementation & Configuration
• Perform and lead the setup, configuration, and deployment of D365 F&O modules.
• End to end management of project/solution management by using tools like Azure Boards for planning and tracking work, Azure Repos for code versioning, and Azure Pipelines for automating build and deployment. Perform all activities from initial user stories and tasks to code, testing, and deployment through integrations with tools like Lifecycle Services (LCS).
• Drive fit-gap analysis and functional documentation. Develop User/Functional Requirements, Functional/Technical Design, System/Business process architecture diagrams.
• Collaborate with development/vendor/managed service teams to define functional specifications for enhancements, bug/fix, customizations, reports, and interfaces. Co-develop or individually develop code/configurations required and coordinate internal development and user acceptance testing of the solution.
• Participate in system validation activities, including IQ/OQ/PQ documentation for regulated environments.
3. Governance & Compliance
• Ensure the ERP system design complies with GAMP 5, SOX, and GxP regulatory requirements.
• Develop and maintain master data governance, change management, and configuration control processes.
• Support audits and inspections through proper documentation and traceability.
• Develop current and future state roadmaps and architecture.
• Assess and align system release plan with Microsoft Dynamics 365 roadmap
4. Stakeholder Collaboration
• Partner with business process owners to define best practices, continuous improvement opportunities, and confirm desired solution to fix the support/bug-fix items raised. Support communities of practice and collaborative development methodology.
• Work independently to perform required fix within the D365 framework. Test and confirm the developed fix with business process owners.
• Work closely with IT, OT, and cloud teams to ensure integrated digital architecture.
• Provide subject matter expertise and training for internal business process owners and super users.
5. Project & Vendor Management
• Support ERP implementation and upgrade projects through all phases — initiation, design, testing, go-live, and hypercare.
• Manage and coordinate external implementation partners and vendors.
• Define KPIs and monitor system performance, adoption, and ROI.
Requirements:
Education
Bachelor’s degree or equivalent experience in computer science, information systems, engineering, supply chain, or related fields required. Microsoft D365 F&O Certification preferred.
Experience
• 8+ years of experience implementing or supporting Microsoft Dynamics AX / D365 F&O.
• Proven expertise across multiple functional domains (Finance, Manufacturing, Supply Chain, Procurement).
• Experience designing integrations between ERP and external systems (LIMS, MES, Payment interface with Bank, External Finance Systems, etc.).
• Strong understanding of ERP data models, workflows, and reporting.
• Strong understanding of functional and solution architecture of, and experience performing code and configuration updates within the following Dynamics 365 modules:
o Finance: General ledger, Cash and bank management, Accounts payable, Accounts receivable. Budgeting, Fixed assets, Cost accounting, PR/PO process, Vendor Management, Cost Accounting and Management
o SCM: Inventory management, Master planning, Procurement and sourcing, Product information management, Production control, Warehouse management, Cost accounting, Cost management, Asset management, including scheduled maintenance and repair tasks
Technical Skills
• Proficient in MS Office Suite. Experience with technology delivery applications across solutions such as (ERP, Manufacturing Execution Systems, Finance Systems, Control Tower).
• Microsoft Certified: Dynamics 365: Finance and Operations Apps Solution Architect Expert certification preferred.
• Experience with emerging technologies (AI/ML, cloud, etc.) as relevant to ERP.
Working Conditions:
Requires up to 10 % domestic and international travel
The anticipated salary for this position will be $165,000 to $190,000. 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:
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.
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
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