Legend Biotech is seeking a Senior Manager, Internal Controls & Sustainability Reporting as part of the Finance team based in Bridgewater, NJ.

Role Overview

The Senior Manager, Internal Controls & Sustainability Reporting is responsible for executing the design, implementation, evaluation, and continuous improvement of the company’s internal control framework across financial reporting and select non‑financial reporting processes. This role plays a critical leadership position in ensuring compliance with SOX (404), managing enterprise-wide control assessments, partnering with business and IT leaders, and serving as a key liaison with Internal Audit and external auditors.
This role is critical to maintaining the integrity of the company’s reporting and supporting growth through strong governance and risk management. The Senior Manager, Internal Controls & Sustainability Reporting will also support the development and enhancement of sustainability reporting, and will have high visibility with finance leadership and the opportunity to meaningfully shape the internal control environment.
Prior experience with sustainability or ESG reporting is not required

Key Responsibilities

SOX & Internal Controls Leadership

• Drive the company’s SOX 404 compliance program end to end, including scoping, risk assessment, control design, testing strategy, remediation, and certification support.
• Evaluate the effectiveness of entity-level, process-level, and IT general controls (ITGCs).
• Support management’s assessment of internal controls over financial reporting (ICFR) and support quarterly and annual certifications.

Risk Assessment & Control Design

• Partner with process owners to identify financial reporting risks and design efficient, scalable controls.
• Assist in the standardization and optimization of controls, reducing redundancy while maintaining compliance.
• Assess the impact of new accounting standards, system implementations, acquisitions, and process changes on internal controls.

Audit & Stakeholder Management

• Coordinate walkthroughs, testing, issue resolution, and audit deliverables, proactively managing timelines and risks to prevent delays.
• Support the remediation of control deficiencies, including significant deficiencies and material weaknesses.
• Track control deficiencies, lead root cause analysis, and oversee remediation efforts through closure.

Process Improvement & Governance

• Support continuous improvement initiatives, including automation and use of governance, risk, and compliance (GRC) tools.
• Support broader GRC initiatives as needed.
• Assist with special projects for the Controller or CFO, including M&A integration and transformation initiatives.

Operational Audits

• Track and drive closure of operational audit deficiencies impacting the finance function, including follow‑up and remediation oversight.
• Collaborate with operational managers to design and implement effective controls to mitigate identified deficiencies.
• Modify policies, procedures, and internal control documentation to reflect corrected processes.
• If necessary, provide training to staff on updated processes and strengthen the overall control culture.

Sustainability Reporting (expected to be 25-50% of role)

• Support sustainability reporting processes aligned with global regulatory frameworks to promote accuracy, completeness, and assurance readiness.
• Assist with the development and maintenance of internal control frameworks over sustainability data.

Requirements

• Bachelor’s degree in Accounting, Finance, or related field.
• 7+ years of progressive experience in internal controls, SOX, public accounting, or a combination thereof. Big 4 or national public accounting firm experience a plus.
• Strong knowledge of COSO framework and exposure to IT general controls and automated control environments.
• Exposure to automation, data analytics, and/or AI‑enabled tools is a plus.
• ESG or Sustainability reporting experience preferred, not essential.
• CPA a plus.
• Knowledge of IFRS a plus.

#Li-LB1

#Li-Hybrid

Legend Biotech is seeking a Sr. Director, R&D Finance FP&A and Portfolio as part of the Finance team based in Bridgewater, NJ.

Role Overview

A key member in the Pipeline Finance team, serving as the dedicated financial partner for the Pipeline functions, leading Finance Analyst in Data Management, Reporting and Dashboarding, and Analytics support senior management decision making. Based in the US, this role reports directly to our CFO.

This role will take charge of end-to-end financial planning, budgeting, forecasting and analysis work in the R&D field, support the establishment and optimization of a standardized FP&A system, provide professional financial support for the implementation of R&D strategies, optimal allocation of resources and investment decisions, collaborate effectively with cross-functional teams, and ensure that the R&D financial FP&A work is aligned with the overall financial strategy of Legend and Pipeline BU.

It translates Pipeline strategy into actionable plans for Pipeline projects, provides tailored financial analysis, budgeting and forecasting, and collaborates with Pipeline leadership, other FP&A colleagues and Pipeline Finance Analysts to ensure financial alignment and data-driven decisions.

The Ideal candidate should have pharmaceutical/biotech FP&A experience with RD familiarity, strong strategic thinking, data analysis and independent work abilities. Must be US-based, able to collaborate cross-functionally in a matrix environment, and support RD Finance strategy execution.

The ideal candidate will have a strong track record of driving improved financial performance, enhancing productivity, strengthening internal controls, and advancing systems and processes. Success requires high learning agility, the ability to collaborate across diverse and geographically dispersed teams, and skill navigating a complex, matrixed environment.
Strong leadership is essential to support business decision-making and ensure smart resource allocation across the R&D pipeline.

Key Responsibilities

Strategy & Portfolio Financial Leadership

• Support RD Finance Head in defining the financial strategy for Pipeline BU, as well as the overall development portfolio, including resource allocation across the pipeline.
• Align Pipeline Finance strategy with Pipeline needs, support FP&A process optimization and standardize best practices across projects and therapeutic areas.
• Provide strategic financial input into the Pipeline Strategy and business plan, enhancing transparency of cost, value, and return on investment.

FP&A Execution & Budget Management

• Develop operating plans and budgets that support timely and high-quality delivery of business objectives, including benchmarking and tracking efficiency improvements.
• Take charge of budget preparation, review, consolidation and variance analysis, ensuring alignment with R&D strategy and Pipeline priorities.
• Regularly report budget execution, forecast deviations and performance to the RD Finance Head with targeted insights.

Consolidation, Analytics, Financial Analysis & Decision Support

• Leading RD Finance consolidation, data management, reporting and analytics.
• Conduct RD-focused financial analysis (cost, ROI, resource efficiency) and apply advanced financial skills to address early development uncertainty.
• Partner with Pipeline leadership team to support project prioritization, resource allocation and investment decisions, maximizing portfolio value.
• Track Pipeline financial KPIs, establish performance measurement frameworks, analyze deviations and propose improvement measures to drive continuous improvement.
• Ensure high-quality financial evaluations for investment decisions and prepare robust financial materials for Senior Executive Team review.

Cost Control & Compliance

• Manage budget execution, warn of risks, coordinate corrective actions and control costs to ensure operational plans remain within established budgets.
• Identify cost optimization opportunities and support implementation to enhance resource utilization efficiency.
• Maintain accountability for SOX and FCF controls, ensure FP&A compliance with Finance Standards, policies and relevant global clinical trial accounting policies.

Collaboration & Process Enhancement

• Collaborate with the Pipeline team to understand business needs and resolve financial collaboration issues.
• Coordinate with other FP&A colleagues and RD Finance Analysts for data/report support, aligning ways of working.
• Identify and support partnership opportunities and external collaborations to enable portfolio growth.
• Develop and optimize FP&A processes that effectively support evolving R&D and Pipeline business needs, contributing to global policy/program implementation

Requirements

• Bachelor's degree in Finance, Accounting, Business Administration, or a related field. MBA, CPA, or CMA is a plus.
• 15+ years of progressive FP&A experience, preferably in the biotech/pharmaceutical industry, with specific experience supporting R&D functions.
• Demonstrates expertise in financial modeling, budgeting, and forecasting.
• Advanced proficiency in Excel (Pivot tables, macros, data modeling).
• Expertise in Anaplan (as the SME) and familiarity with ERP systems (e.g., SAP).
• Experience with data visualization tools (e.g., Tableau, Power BI).

#Li-LB1

#Li-Hybrid

Legend Biotech is seeking a Legal Operations Manager, Contracts & Privacy as part of the Legal team based in Bridgewater, NJ.

Role Overview

The Legal Operations Manager, Contracts & Privacy supports the Legal Department by managing day-to-day contract lifecycle administration, coordinating operational aspects of the company’s Global Privacy program and assisting with legal operations processes and tools. This role is highly execution-oriented and works closely with attorneys and cross-functional partners to ensure efficient, compliant, and well-organized legal workflows in a fast-paced biotech environment. The position will coordinate closely with Legend Biotech’s Chief Privacy Officer and reports to Legend Biotech’s Deputy General Counsel.

Key Responsibilities

Contract Lifecycle Administration

• Coordinate the end-to-end contract process, including intake, routing, approvals, execution, and filing
• Maintain and update contract records in the company’s CLM system, ensuring accuracy and completeness of data
• Ensure contracts comply with company standards, regulatory requirements, and approval processes
• Populate basic contract template agreements (e.g. NDAs, consulting agreements, etc.)
• Track contract status, key dates (e.g., expirations, renewals), and obligations
• Assist in maintaining contract templates, standard forms and clause libraries
• Respond to internal inquiries regarding contract status and process
• Perform other contracts-related activities and tasks as assigned

Privacy Program Support

• Support day-to-day operations of the company’s Global Privacy program
• Assist with privacy impact assessments, security risk assessments and other privacy reviews and documentation
• Maintain records related to data processing activities and ensure compliance with data subject right requests
• Help coordinate privacy training, awareness initiatives and policy updates
• Track and escalate privacy-related issues and requests to appropriate stakeholders
• Organize and coordinate privacy champions meetings to ensure privacy requirements are understood and implemented
• Coordinate implementation of data mapping plan to maintain up to data inventory, liaising with system/business owners, and assist with other EU GDPR operational matters
• Track key privacy metrics (e.g., breaches report, PIAs conducted, DSARs received)
• Assist with clinical trial privacy matters, including informed consent (ICF) updates, investigator/HCP notice, and related matters

Legal Operations Support

• Maintain organized legal files, databases, and corporate records
• Support subsidiary management across US & EU jurisdictions
• Support reporting efforts by compiling basic KPIs, metrics and data for the Legal Team
• Assist with invoice processing and vendor onboarding as needed
• Support implementation and ongoing management of legal systems and tools

Requirements

• Bachelor’s degree or equivalent experience required
• 4+ years of experience in legal coordination, contract administration, paralegal support or legal operations
• Experience with contract management systems or similar tools strongly preferred
• Basic familiarity with data privacy concepts and regulations (e.g., GDPR, CCPA, HIPAA) is a plus
• Strong organizational and administrative skills with high attention to detail and accuracy
• Ability to manage multiple tasks and deadlines effectively
• Effective communication and responsiveness
• Ability to follow established processes and identify opportunities for improvement
• Comfort working with systems, data and cross-functional teams

#Li-FB1

#Li-Hybrid

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

This territory cover - New York City, New Jersey, Delaware, Eastern Pennsylvania, Maryland, Virginia, Tennessee, Kentucky

Summary of Job:

The Regional Account Manager (RAM) – Rare Disease is a critical commercial role responsible for expanding the diagnosed patient population and driving appropriate treatment initiation through education-driven, data-informed field engagement. This role is designed to complement existing Regional Business Manager (RBM) coverage by placing primary emphasis on new and earlier patient identification, diagnostic pathway enablement, and referral network activation.

In rare disease markets, where growth is driven by patient identification rather than market share shifts, the Regional Account Manager focuses on uncovering diagnostic gaps, enabling earlier disease recognition, and ensuring appropriate handoff of qualified patient opportunities to RBMs for treatment initiation and account execution. The RAM serves as a field integrator across the local ecosystem and works in close collaboration with Regional Business Managers and relevant cross-functional partners

Essential Functions:

Patient Identification & Diagnostic Enablement

• Identify rare disease patients through engagement with healthcare providers, including but not limited to IM/FP, General Pediatrics, Rheumatology, Physical Therapy, Pain Management, and other non-traditional specialties
• Identify and address diagnostic gaps within targeted accounts that may delay or prevent accurate diagnosis
• Map, influence, and support local diagnostic and referral pathways to reduce time from disease suspicion to confirmed diagnosis
• Support appropriate use of diagnostic tools and specialist referrals, including utilization of approved HCP identification tools
• Serve as a field integrator to help ensure potential patients are identified throughout the diagnostic journey

Territory Strategy & Data-Driven Execution

• Develop and execute a business plan focused on patient identification and diagnostic activation
• Utilize claims data, internal analytics, Power BI mapping, and other approved data sources to identify high-probability patient opportunities
• Continuously refine targeting and territory strategy based on real-world outcomes, field insights, and performance metrics
• Analyze local and regional trends to inform short- and long-term business planning

Cross-Functional Collaboration

• Partner closely with Regional Business Managers and appropriate cross-functional partners to ensure coordinated, compliant patient identification efforts
• Execute compliant transitions of qualified patient opportunities to RBMs for treatment initiation and account execution

Compliance & Professional Conduct

• Communicate all disease, diagnostic, and product-related information in a truthful, non-misleading manner consistent with company policies and all applicable laws and regulations
• Utilize only on-label, approved materials and seek guidance from management, Compliance, or Legal when uncertainty exists
• Adhere strictly to all regulatory, compliance, and company policies, including appropriate handling of confidential patient information

Success Metrics (KPIs)

Primary Metrics

• Number of newly identified and qualified patient opportunities
• Growth in confirmed diagnoses
• Expansion of new prescriber base
• Qualified patient transitions to RBMs

Secondary Metrics

• Conversion of qualified transitions to enrollment forms
• Contribution to new patient starts
• Percentage of transitions meeting defined qualification criteria (including pedigree relevance and confirmed referral pathway)
• Educational discussions, including speaker programs and conferences

Job Requirements:

Education 

• Bachelor’s degree in science or business required. 

Experience 

• Minimum of 5 years of rare disease experience or experience selling in complex disease states preferred
• Demonstrated experience and success in patient identification, disease education, or complex diagnostic markets
• Proven ability to operate effectively in long-cycle sales environments
• Strong analytical skills with the ability to translate data into actionable territory strategies
• Demonstrated ability to influence multiple stakeholders without direct authority
• Strong verbal, written, presentation, and interpersonal communication skills
• Ability to work autonomously while maintaining strong cross-functional collaboration
• Residence within close proximity to assigned geography
• Commitment to continuous learning and professional development

Preferred Qualifications

• Experience in rare disease or other highly specialized therapeutic areas
• Demonstrated understanding of referral networks
• Strong business planning and strategic thinking capabilities
• Strong business development skills

Travel Requirements

• Requires up to approximately 70% domestic travel
• Must possess a valid U.S. driver’s license with a clean driving record
• Position requires overnight domestic travel based on regional and territory needs

Technical Skills

• Proficient in Microsoft Office Suite and CRM systems
• Comfortable with data visualization and analytics platforms

Non-Technical Skills

• Highly motivated with strong attention to detail
• Ability to manage ambiguity and complexity
• Strong problem-solving skills
• Cultural sensitivity and ability to collaborate within a multinational organization

The anticipated salary for this position will be $185,500 to $202,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

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

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at  212 Carnegie Center Dr. Suite 510 Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

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

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

Recruitment & Staffing Agencies

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

#LI-PE1

#LI-Field

The Auth0 Sales Team

Auth0 supports Okta’s vision of freeing anyone to safely use any technology by providing a secure, highly available, enterprise-grade platform that secures billions of log-ins every year for Consumer and SaaS applications. As an Auth0 AE, you will drive territory growth through both net new logos and cultivating relationships to develop and grow existing Auth0 customers. With the support of your Okta ecosystem, your focus will be on consistent results and an unwavering commitment to our customers.

The Strategic Auth0 Account Executive Opportunity

The successful Auth0 Account Executive is a highly motivated, self-driven, and experienced Account Executive who is passionate about security and about driving protection against the biggest identity threats.

As an Auth0 AE, you will be focused on providing value to Application Development teams (Engineering, Product, Security and Architecture). You will continually drive territory growth through both net new logos as well as through cultivating relationships to develop and grow existing Auth0 customers. 

This role requires travel to our San Francisco, CA or Chicago, IL office for in-person onboarding during the first week of employment. If reasonable accommodation is needed to participate in the job application, interview process, or onboarding please use this Form to request an accommodation.

What you’ll be doing: 

• Build a plan to guide your long-term approach to net new logo pipeline generation 
• Consistently deliver revenue targets to support YoY territory growth 
• Identify, develop and execute account strategies to generate pipeline, drive sales opportunities and deliver repeatable and predictable bookings
• Identify, target and gain access to appropriate leaders in prospect accounts, building and cultivating your network of decision makers  
• Scope, negotiate and close agreements to meet and exceed revenue quota targets 
• Holistically embrace, access, and utilize partners to identify and open opportunities 
• Build and nurture effective working partnerships within your Okta ecosystem (xDRs, Partners, Presales, Customer First, etc) 
• Travel as necessary to build and cultivate customer and prospect relationships

What you’ll bring to the role:

• 12+ years success in growing revenue for sophisticated, complex enterprise SaaS products
• Ability to evangelize, educate and create demand within the CTO organization, with a strong track record of pitching and closing to Product, Engineering, and Architecture decision makers
• Deep technical discovery skills that resonate with the developer community 
• Strong technical acumen with proven ability to connect a technical sale to a companies’ business outcomes
• Excellent communication and presentation skills with audiences of all levels and all technical aptitudes
• Confident and self driven with the humility required to successfully work in teams
• Expertise using a Sales Framework such as MEDDPICC, Challenger or Sandler (we use MEDDPICC)

#LI-Remote

P22910_3412170

Position Overview 

The Vice President (VP), Clinical Development - Infectious Disease is a leadership role responsible for guiding Tonix Pharmaceuticals' clinical development programs. Reporting directly into the Chief Medical Officer, this position provides strategic oversight to ensure excellence in clinical research, regulatory interactions, and product approvals within Tonix's core therapeutic area of Infectious Diseases, initially with focus on prophylactic monoclonal antibodies, live virus vaccines and Lyme disease. 

Essential Duties

• Define and lead the company’s clinical development strategy for assigned vaccines and prophylactic antibodies, ensuring alignment with corporate vision and regulatory expectations with Tonix’s pipeline and therapeutic focus.
• Oversee the planning, design, execution, and completion of clinical trials (Phases I-IV), ensuring efficiency, scientific rigor, and compliance with regulatory standards, timelines, and budgets. Oversee the development of clinical protocols, investigator brochures, statistical analysis plans, and other critical regulatory documents. Collaborate with clinical operations to ensure the quality and integrity of clinical data; and support scientific communications and publications regarding pipeline programs. Maintain a strong focus on innovation in clinical trial design, patient-centric approaches, and biomarker-driven strategies.
• Oversee the selection and management of CROs, academic partnerships, and external collaborations to optimize clinical trial execution.
• Drive a culture of operational excellence, regulatory compliance, quality assurance, adherence to GCP guidelines, ethical considerations, and scientific integrity across Clinical Development.
• Represent the company at key scientific conferences, industry consortia, and investor presentations to enhance corporate reputation.
• Provide leadership to the Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams.
• Provide medical and scientific leadership to cross-functional teams, integrating insights from medical affairs, regulatory affairs, and commercial teams to drive program success.
• Partner with R&D, Medical Affairs, Commercial, and Business Development teams to align clinical development with broader corporate objectives.
• Serve as the clinical development leader for assigned pipeline programs in interactions with global regulatory agencies (FDA, EMA, etc.), ensuring effective engagement, submission strategies, and post-approval commitments; lead the preparation and review of regulatory submissions, including INDs, NDAs, BLAs, and CTAs.
• Cultivate and maintain strong relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations specific to the products and indications for the programs led.
• Build, mentor, and lead high-performing teams, fostering a culture of excellence, innovation, and accountability.  
• Strong ability to build and sustain meaningful relationships with KOLs, regulatory bodies, and external strategic partners.
• Exceptional leadership, mentorship, strategic planning, and operational management skills.
• Excellent communication, interpersonal, and negotiation abilities

Necessary Skills and Abilities:

• Demonstrated success in leading clinical development programs.
• Regulatory Compliance: Extensive experience with regulatory interactions, submissions, and product approvals.
• Experience in comprehensive budget management.

Educational Requirements:

• MD or DO

Experience Requirements:

• Experience: 10-15 years of relevant experience, demonstrating progressive leadership in clinical development within pharmaceutical or biotechnology companies, including prior experience serving at the Senior Director level or above in Clinical Development organizations.
• Board certification in Infectious Disease a plus
• Expertise and experience in infectious diseases.
• Prior work with Lyme disease, live viral vaccines and or prophylactic monoclonal antibodies a major plus.

Position Reports to: Senior Director, Loan Origination 
Department: Financing
Location: This is a US-based remote role, with a requirement to be located in New Jersey. 
Salary Range: $129,400 - $143,800 

About Nonprofit Finance Fund  

Nonprofit Finance Fund® (NFF®) is a nonprofit lender, consultant, and advocate. For more than 40 years, we’ve helped organizations access the money and resources they need to realize their communities’ aspirations. Alongside others, we’re working to build community wealth and well-being and put affordable housing, essential services, quality jobs, and excellent education within reach of more people. At NFF, we envision a world of shared prosperity, where communities have the capital, community assets, knowledge, and agency to thrive. Learn more about our work to achieve our vision through our Theory of Change and Values.   

About This Role 

The Director, Loan Origination (New Jersey) is responsible for driving lending activity in the state of New Jersey. The Director cultivates relationships with clients that may have financing needs, builds a continuous pipeline of new lending opportunities, and evaluates incoming loan requests for viability and preliminary loan structuring. In support of and alongside this work, this role draws on the existing relationships, programs, and products NFF is currently deploying across the state, which include debt products and financial strategy consulting.

NFF has offices in Boston, New York, Philadelphia, Oakland, and Los Angeles. This is a US-based remote role, with a requirement to be located in New Jersey. NFF has core business hours where we expect all staff to be available from 9:00 am to 5:00 pm local time. The role requires a minimum of 25% travel. 

What You Will Do 

Essential responsibilities for this role include, but are not limited to: 

Relationship Management 

• Develop and nurture new and existing client relationships ensuring a smooth transition through the financing process 
• Engage with clients in ways that demonstrates empathy and garners understanding of their experiences and needs, including those who have faced barriers to equitable access of capital  
• Develop financing solutions that reflect client needs while working closely with all Loan Origination, Underwriting, Program, Closing, and Portfolio Management staff to ensure excellent customer service   
• Cultivate and maintain relationships with lending partners (banks, CDFIs, foundations, institutional investors and other capital providers and intermediaries) as well as stakeholders such as consultants, government agencies, nonprofit networks and advocacy organizations  
• Work across the organization to identify business development opportunities and help coordinate lending activity so that it intersects with NFF’s overall priorities and key relationships 

Loan Originations 

• Build a continuous pipeline of new lending opportunities consistent with NFF’s loan products, programs, deployment goals, mission, and strategy 
• Assess new loan requests, discuss product options with clients, and propose viable loan structures for internal approval 
• Gather basic due diligence, conduct initial assessment and analysis of client prospects, and draft initial loan overview memos in advance of the issuance of term sheets.  
• Proactively monitor industry and regional trends, policies, funding, and other external drivers that may inform strategies for pipeline development 

Program Management 

• Originate loans from NFF’s BEACoN NJ program, a $20MM 10-year statewide revolving loan fund to support community ownership of assets for nonprofits 
• Maintain an active pipeline and relationships with nonprofits, developers, consultants, and other stakeholders in connection with ongoing BEACoN NJ lending 
• Provide client and project-related information to support periodic investor reporting 
• Represent NFF and the BEACoN NJ program in public events, conferences, media, partner and funder meetings, and other external-facing opportunities as needed 
• Leverage other NFF lending programs, including the NJ Social Impact Investing Fund (a flexible off-balance sheet statewide loan fund), Faith in our Communities (a credit-enhanced faith-based lending program), and other programs that NFF may develop over time 

Strategy and Market Development 

• Support the development and implementation of a tactical plan that will consistently generate a viable pipeline of high credit quality clients and transactions including, but not limited to, on-balance sheet lending, NMTC transactions, off-balance sheet opportunities, and special programs   
• Identify, build, and nurture relationships with client segments in line with NFF's mission and strategy  
• Connect with communities and identify ways to address inequitable access to capital  
• Identify and develop community partnerships to support product and process design  
• Support, where there is opportunity, the integration of capital delivery and technical assistance, to ensure the capacity building needs of borrowers are met with a client-centered relational approach 

Who You Are and Minimum Qualifications 

• Bachelor’s degree from an accredited institution in Finance, Economics, Accounting, or a related field, or equivalent combination of education, training, and experience in financial services and/or lending  
• Seven (7) years of progressive professional experience in the financial services industry as a loan officer or similar lending roles 
• Demonstrated experience in credit analysis, loan structuring, and business development, with sector expertise in at least one of the following: affordable housing, education, healthcare, human services, or other community facilities  
• Market knowledge and existing relationships with nonprofits and related stakeholders in New Jersey 
• Proven ability to handle sensitive, confidential information with high degree of integrity and discretion  
• Established effectiveness in clear, proactive verbal and written communication, coupled with strong interpersonal skills  
• Proficiency with online collaboration tools, Salesforce or similar CRM software, and Microsoft Office Suite 

The Strongest Candidates Will Have 

• Commitment to NFF’s values, mission, and approach to community impact 
• Strong understanding of CDFIs and their role in nonprofit financing 
• Familiarity with real estate and financing structures 
• Experience with nonprofit accounting, financial statements, and business models 
• Experience with common community development finance programs, including New Markets Tax Credits and Low Income Housing Tax Credits 
• Strong organization and project management skills 
• Experience leading cross-functional efforts in a matrixed organization 
• Ability to work independently and effectively in a remote environment and build strong relationships with colleagues and partners across geographies and time zones 
• Willingness to collaborate with a dynamic and mission-driven team 
• Learning orientation and commitment to continuous learning and improvement 
• Ability to thrive in a fast-paced, changing, and at times ambiguous context 

Benefits and Compensation 

NFF offers a generous benefits package that currently includes up to twenty (20) paid holidays/business closure days, three (3) floating holidays, flexible time off, group medical insurance with a funded health reimbursement account, dental and vision plans, life insurance and disability plans, a retirement plan with both a non-elective employer contribution (4%) and additional match contribution (up to 2%), a “work from home” fund, and flexible spending accounts to cover health, dependent care, and commuter costs. 

This is an exempt, full-time role with a compensation range of $129,400 - $143,800. A compensation offer is based on a candidate’s background and years of relevant experience, with consideration for internal equity. Because of our strong commitment to equity and growth, we do not negotiate compensation offers. 

NFF is an equal opportunity employer and does not discriminate against any applicant or employee because of race, color, religion, sex, national origin, disability, genetic information, age, or military or veteran status in accordance with federal law. In addition, NFF complies with applicable state and local laws governing non-discrimination in employment in every jurisdiction in which it maintains facilities. NFF also provides reasonable accommodation to qualified individuals with disabilities in accordance with applicable laws. NFF does not employ individuals based outside of the United States. Click here to view NFF’s Fair and Equitable Practices.  

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

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

Essential Functions:

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

Requirements:

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

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

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

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

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

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

About Probio:

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

Position Summary

(Sr.) EHS Manager is responsible for establishing, leading, and continuously improving the EHS program for a single-site biologics and GCT CDMO in New Jersey, covering process development (PD) through GMP manufacturing of plasmid DNA, viral vectors and biologics. This role ensures full compliance with federal, state, and local regulations, supports client and corporate requirements, and drives a strong safety culture across labs, pilot, and GMP suites.

Key Responsibilities

• Own and manage the site EHS Management System in compliance with OSHA, EPA, DOT, NFPA, and NJ state/local regulations.
• Develop, maintain, and implement EHS policies, procedures, and programs.
• Lead environmental compliance: hazardous/universal waste, wastewater, air emissions, Tier II/SARA reporting, and NJDEP permits.
• Lead or support the Biosafety Officer function; oversee biosafety programs for BSL-2 / BSL-2+ plasmid and lentiviral operations.
• Ensure safe handling and control of viral vectors, biological materials, chemicals, cryogens (LN2), and compressed gases.
• Plan and coordinate industrial hygiene assessments and occupational health programs (e.g., respiratory protection, medical surveillance).
• Lead EHS risk assessments, incident/near-miss investigations, root cause analysis, and CAPA; track and report EHS KPIs.
• Deliver EHS onboarding and refresher training; maintain strong floor presence and coach line leadership.
• Represent EHS during client audits, regulatory inspections, and site visits; support EHS sections of quality/technical agreements.
• Own the site Emergency Response Plan and coordinate drills and external responder engagement.

Qualifications

• Bachelor’s or above degree in Environmental Science, Occupational Health & Safety, Industrial Hygiene, Engineering, Biology, or related field required.
• 10+ years of EHS experience with site-level responsibility in biotech/pharma/CDMO or similar regulated environment.
• Strongly preferred: experience with biologics or viral vector operations (plasmid DNA, lentivirus, BSL-2 labs, GMP manufacturing).
• Solid knowledge of OSHA 29 CFR 1910, RCRA, basic CAA/CWA requirements, DOT HazMat; familiarity with biosafety standards (BMBL, NIH Guidelines).
• Preferred certifications: CSP, CIH, CHMM, RBP/CBSP or equivalent.
• Proven ability to work cross-functionally, communicate clearly, and provide practical, operations-friendly EHS solutions in a fast-paced setting.

The estimated salary range is $100,000 - $150,000, based on experience level.

#LW

# PB

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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Remote #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to 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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to 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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to 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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to 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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

Who We Are

Cross River builds the infrastructure behind the world’s most innovative financial products. Our technology and capital solutions power payments, cards, lending, and digital asset capabilities that move money safely, instantly, and inclusively — trusted by leading fintechs, enterprises, and disruptors across the globe.

Our mission is simple: to build the financial infrastructure that expands access and opportunity for all. Guided by a culture of collaboration, curiosity, and purpose, Cross River has been named one of American Banker’s Best Places to Work in Fintech year after year. Whether you’re designing code, solving regulatory puzzles, or developing strategy, you’ll join a team where innovation and integrity drive everything we do — and where your work helps shape the future of finance.

What We're Looking For

The AI Transformation Manager reports to the Chief Data and AI Officer and plays a critical role in driving Cross River’s AI-led transformation and commercialization strategy. This position is responsible for orchestrating the end-to-end implementation of AI initiatives across the enterprise—bridging strategy, productization, compliance, and delivery to ensure measurable business impact. The ideal candidate combines deep expertise in AI/ML program management with a pragmatic understanding of financial services and regulatory environments.

Responsibilities:

Strategy & Governance

• Define and manage the AI Transformation roadmap, ensuring alignment with Cross River’s strategic objectives, regulatory standards, and innovation priorities.
• Partner with business, data, and technology leaders to identify AI-driven opportunities for efficiency, risk management, and new revenue models.
• Establish a governance framework for AI projects, including evaluation metrics, responsible AI principles, and lifecycle management.
• Oversee commercialization of AI capabilities, enabling scalable deployment of internal tools and potential external monetization opportunities.

Program Execution & Delivery

• Lead the planning, coordination, and execution of AI initiatives across multiple business domains—banking, lending, risk, compliance, and customer experience.
• Develop and maintain a portfolio management system for all AI programs, ensuring transparency on timelines, costs, dependencies, and outcomes.
• Ensure data readiness and model governance across all AI deployments in close partnership with data engineering and compliance teams.
• Track and report on transformation metrics, including adoption, ROI, and productivity gains.

Collaboration & Change Management

• Partner with product, engineering, operations, and risk teams to embed AI solutions into enterprise workflows.
• Drive organizational change management to enable smooth adoption of AI technologies, ensuring training and alignment across teams.
• Serve as a liaison between business and technical teams, translating complex AI capabilities into actionable business insights.
• Promote a culture of responsible AI innovation that balances experimentation with ethical standards and risk management.

Commercialization & Market Enablement

• Identify opportunities to externalize AI capabilities through partnerships, APIs, and new product lines.
• Collaborate with external vendors, startups, and research organizations to expand the bank’s AI ecosystem.
• Support the Chief Data and AI Officer in defining AI monetization strategies and evaluating go-to-market models.

Basic Qualifications:

• 10+ years of experience in technology, analytics, or transformation roles, with at least 5 years in AI/ML program or product management.
• Proven experience leading cross-functional AI initiatives from conception through implementation in a regulated industry (preferably financial services, fintech, or banking).
• Strong understanding of AI platforms, MLOps, model governance, and data management frameworks.
• Experience managing stakeholder engagement, budgets, and vendor relationships for large-scale transformation programs.
• Exceptional ability to translate technical AI concepts into business outcomes and communicate effectively at all organizational levels.

Preferred Qualifications:

• Master’s degree in Business, Data Science, Engineering, or a related field.
• Prior experience applying AI solutions in regulated environments, such as banking, healthcare, or insurance.
• Familiarity with AI governance frameworks, including bias mitigation, interpretability, and model monitoring.
• Experience in commercialization or business development related to AI-driven products or services.
• PMP, Agile, or equivalent program management certification preferred.

Leadership & Impact:

The ideal candidate will demonstrate a track record of driving complex, multi-stakeholder AI initiatives, combining visionary thinking with disciplined execution. They will be a trusted advisor to the Chief Data and AI Officer and a change leader influencing how AI transforms Cross River’s core business and innovation strategy.

#LI-JJ1 #LI-Hybrid #LI-Onsite

Salary Range: $170,000.00 - $200,000.00

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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to 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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to 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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to 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:

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

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

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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

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

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

Recruitment & Staffing Agencies

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

#LI-Tt1 #Hybrid #Princeton

About the role:  

As B2C2 continues its rapid growth across global markets, we are seeking an execution-focused senior compliance leader to strengthen regulatory engagement discipline, drive operational rigor across core compliance programs, and ensure structured delivery in a fast-evolving supervisory environment. This individual will serve as a key leader in the U.S. Compliance function – driving team performance, strengthening regulatory relationships, engaging with key external relationships, and enhancing our ability to operate at a pace in a fast-evolving regulatory landscape. You will become a main point of contact for new regulations and existing ones, as well as helping the team to design and implement the best in practice controls, policies, procedures, and thought leadership in the industry.  This role offers the opportunity to operate with significant responsibility and visibility across the Legal & Compliance Division, with scope to take on broader leadership responsibilities as the firm continues to scale its regulatory footprint.

Core Duties and Responsibilities:

• Point of contact, develop and implement the global compliance programs, including Know Your Customer (KYC), Anti-Money Laundering (AML), trade surveillance, sanctions for our growing US business.
• Advise and implement enhancements to B2C2’s Compliance Program, including oversight of policies and procedures 
• Strengthen and maintain the compliance framework and governance through the development and implementation of B2C2’s policies and procedures.
• Own coordination, drafting, internal review workflow, and delivery of regulatory responses, examinations, audits, and supervisory engagements, ensuring clarity of scope, executive alignment, and disciplined communication.
• Provide day-to-day leadership across the Americas compliance team, and on assigned global committees as needed, setting clear performance standards, accountability expectations, and delivery milestones.
• Implement structured tracking of regulatory initiatives, remediation efforts, and supervisory commitments.
• Manage and address any conflicts of interest that may arise.

Regulatory Program Leadership

• Serve as a senior point of contact for U.S. regulatory bodies, including NYDFS, FinCEN, SEC, CFTC, and state regulators, and be capable of stepping in on global matters if needed.
• Ability to lead day-to-day execution and enhancement of core compliance programs, including:
• Know Your Customer (KYC) / Customer Due Diligence (CDD)
• Anti-Money Laundering (AML)
• Sanctions compliance
• Transaction monitoring and trade surveillance
  

• Develop and maintain scalable compliance frameworks, ensuring readiness for new regulatory regimes (e.g., stablecoin oversight, digital asset licensing requirements).

Team Development & Leadership

• Lead day-to-day execution of key compliance initiatives across the Americas compliance team and support performance management and development of team members.
• Own coordination, drafting, and internal approval workflow for regulatory responses, ensuring clarity of scope, accountability, and executive alignment prior to submission.
• Drive execution discipline across regulatory initiatives, audits, and licensing efforts.
• Drive a culture of accountability, performance, and empowerment.
• Set and track team goals aligned to business priorities and regulatory milestones.

This role will serve as a key execution partner to the CCO Americas and the Global Chief Legal Officer in strengthening the firm’s U.S. regulatory governance framework.

 Cross-Functional Execution

• Collaborate effectively with/in the Legal and Compliance Division, Risk, Operations, Trading, Sales, and Technology to ensure compliance is embedded into product and operational design.
• Establish clear escalation pathways for regulatory risk matters to senior management and the Global Chief Legal Officer, ensuring transparency and timely decision-making.
• Serve as a key stakeholder in regulatory change initiatives and licensing efforts.
• Contribute to the global compliance strategy and help align the Americas function with broader LCD and business goals.
  
  

 External & Internal Communications

• Represent the firm in supervisory interactions with confidence, clarity, and preparation; lead structured regulator meetings with defined agendas, objectives, and documented follow-up.
• Lead responses to regulatory inquiries, exams, and audits.
  Draft and present policies, memos, and regulatory position papers to internal and external stakeholders.
  

Required Skills and experience:

• 5+ years compliance and/or legal experience in the financial services industry. 
• Must possess a robust understanding and experience within a digital assets or trading firm.
• Ability to manage teams and deliver results in dynamic, high-pressure environments
• Experience operating in highly regulated financial institutions where regulator engagement discipline and governance frameworks are critical.
• Demonstrated experience leading regulatory examinations or supervisory inquiries in a primary coordination role.
• In-depth knowledge of the local regulatory landscape as this person will be leading interactions with regulators.
• Demonstrated ability to structure ambiguous regulatory inquiries into clear action plans with defined ownership and timelines.
• A strong ability to work and thrive in a fast-paced, start-up environment operating in an uncharted regulatory environment.
• A record of success influencing key decision makers through a combination of knowledge, reasoning, and relationships.
• Comfortable operating with senior executive visibility and accountability.
• Exceptional communication skills, as you will be working collaboratively across various teams, including ExCo, Legal, Operations, Risk and Audit.
• An ability to quickly synthesize information, make decisions and respond to shifts in priorities.

What We’re Looking For

• Execution-oriented mindset: You get things done and bring others along with you.
• Strong leadership presence: You know how to manage a team, provide direction, and hold others accountable with clarity and professionalism.
• Operational discipline: Ability to translate regulatory obligations into structured execution plans with clear ownership and deadlines.
• Collaborative operator: You work fluidly across teams, communicate clearly, and can both support and challenge stakeholders constructively.
• Adaptability: You’re comfortable navigating ambiguity and shaping structure in a fast-evolving regulatory and business environment.
• Integrity and sound judgment: You act as a trusted steward of risk and reputation.