Legend Biotech is seeking a Director, Thought Leader Liaison & Strategic Alliances, Northeast as part of the Commercial team based in Somerset, NJ.

Role Overview

The Director, Thought Leader Liaison (TLL) is a senior individual contributor responsible for shaping and advancing the organization’s thought leader engagement strategy across the cell therapy landscape. This role operates at an enterprise level, cultivating high-impact relationships with national and regional experts to inform strategy, accelerate adoption, and elevate the organization’s scientific and clinical presence.
Unlike the Associate Director TLL role, which is primarily focused on execution within a defined scope, the Director TLL role is distinguished by breadth of influence, strategic insight generation, and executive-level engagement. The Director TLL serves as a trusted scientific partner to external experts and an internal advisor to senior leadership—translating complex field insights into actionable enterprise strategy.

Key Responsibilities

Strategic Thought Leader Engagement

• Lead relationships with top-tier national and regional thought leaders in cell therapy, oncology, and transplant.
  
• Design and execute long-term engagement strategies aligned to enterprise priorities and lifecycle needs.
  
• Serve as a credible scientific partner in discussions spanning clinical practice, research trends, operational challenges, and future innovation.
  

Enterprise-Level Insight Generation

• Synthesize insights across engagements to identify emerging trends, unmet needs, and strategic opportunities.
  
• Translate field insights into clear, executive-ready narratives that inform strategy, messaging, evidence generation, and education.
  
• Proactively identify gaps between internal strategy and external reality, elevating recommendations to leadership.
  

Executive & Cross-Functional Partnership

• Act as a strategic advisor to Medical Affairs, Clinical Development, Commercial, Marketing, Market Access, and Clinical Education.
  
• Support executive-level meetings, advisory boards, and strategic initiatives requiring deep scientific and field expertise.
  
• Influence internal decision-making without direct authority through credibility, data, and perspective.
  

Scientific Credibility & External Presence

• Represent the organization with a high level of scientific rigor and professionalism in external forums.
  
• Contribute to the shaping of advisory boards, peer-to-peer forums, and scientific exchange models.
  
• Ensure compliant, balanced, and ethical engagement with thought leaders at all times.
  

Standards Setting & Capability Elevation (Non-Managerial)

• Serve as a role model for advanced TLL capabilities, including insight quality, engagement depth, and strategic thinking.
  
• Contribute to the evolution of insight frameworks, engagement models, and performance standards.
  
• Provide informal mentoring and best-practice sharing across the TLL team without direct supervisory responsibility.
  

Requirements

• Minimum: Bachelor’s Degree from accredited college or university.
• Advanced degree also considered.
• Minimum of a bachelor’s degree in a related field required; MD, PharmD, PhD or other related graduate degree preferred.
  
• 10-15 years of pharmaceutical or biologics industry experience in sales, marketing, key account management, or medical engaging with thought leaders or influential HCPs required.
  
• 4 years of relevant Multiple Myeloma, Cell Therapy, or Oncology experience required.
  
• Deep expertise in oncology, cell therapy, transplant, or related therapeutic areas.
  
• Demonstrated success influencing senior internal and external stakeholders.
  
• Proven ability to translate complex scientific dialogue into actionable strategic insight.
  
• Able to work cross-functionally with internal and external stakeholders to innovate, collaborate, and deliver results.
  
• Valid driver's license.
  
• Ability to travel 75 – 85%.
  
• Required to exercise sound judgment and discretion, independently assess and resolve complex situations and shift priorities as the need arises.
  
• Possess excellent oral and written communication skills.
  
• Able to coordinate multiple projects with overlapping deadlines and complete tasks autonomously.
• Challenges the status quo, looks for/adopts best practices, embraces change.
  
• Must demonstrate flexibility, while maintaining a sense of urgency.
• Demonstrated ability to access and understand challenges and educational needs of stakeholders and accounts within the assigned geography.
  
• Proven customer focus.
  
• Demonstration of strong in-person and virtual presentation and engagement skills.
  
• Superior clinical skills and business acumen with the proven ability to excel in a technically complex and ambiguous environment.
  
• Experience working with CAR-T or other cell and gene therapies.
  
• Proven track record of shaping strategy through field-derived insights.
  
• Demonstrated ability to identify critical activities and tasks and adjusts priorities to meet organizational goals and objectives.
  
• Demonstrated ability to read situations quickly, anticipate and adjust for problems and roadblocks.
  
• Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint).

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Legend Biotech is seeking an Associate Director, Omnichannel Advanced Analytics as part of the Insights & Analytics team based in Bridgewater, NJ.

Role Overview

The Associate Director (AD), Omnichannel Advanced Analytics, is a senior analytics leader responsible for driving insight generation and performance measurement across non‑personal promotion (NPP) and omnichannel engagement. This role builds a rigorous, scalable understanding of which digital and non‑personal tactics work, for whom, and why—enabling data‑driven optimization of channel strategy, content, orchestration, and investment across the customer journey.

The AD partners closely with Commercial, Marketing, Field Operations, and IT to translate complex data into actionable insights, influence strategic decision‑making, and embed advanced analytics into omnichannel planning and execution. This role also provides people leadership and thought leadership within the broader Insights & Analytics organization.

Key Responsibilities

Omnichannel Analytics Strategy & Ownership

• Own and evolve the omnichannel analytics roadmap for NPP, including measurement frameworks, KPI definitions, test‑and‑learn approaches, and standardized performance readouts aligned to brand and marketing decision cycles.
• Establish clear success metrics and accountability for non‑personal and digital engagement, ensuring consistency across brands, channels, and customer segments.
• Serve as the subject‑matter expert on omnichannel and NPP measurement, advising senior Commercial and Marketing leaders on performance interpretation and optimization opportunities.

Measurement of Non‑Personal Promotion & Digital Engagement

• Quantify the effectiveness and impact of NPP tactics, including but not limited to email, web journeys, paid media, webinars/virtual programs, rep‑triggered digital, and other non‑personal touchpoints.
• Assess channel contribution and interaction effects across the customer journey, supporting smarter investment allocation and engagement sequencing.
• Design and execute test‑and‑learn initiatives to evaluate new tactics, content strategies, and orchestration approaches.

Advanced Analytics & Insight Development

• Develop and operationalize advanced analytic assets that enable smarter, more personalized engagement, including:
• Customer segmentation and audience prioritization models
• Response and propensity models (e.g., engagement likelihood, next‑best‑action, or next‑step likelihood)
• Content and channel optimization models (what message works, where, and when)
• Journey analytics, including pathing analysis, drop‑off identification, and sequencing optimization.
• Translate advanced analytics outputs into clear, actionable recommendations for non‑technical stakeholders.

Cross‑Functional Partnership (Commercial & IT) and Leadership

• Partner closely with Commercial, Brand Marketing, Digital, Field Operations, and Market Research teams to align analytics priorities with business objectives and omnichannel strategy.
• Collaborate with IT, Data Engineering, and platform teams to ensure scalable, compliant, and reliable data pipelines, analytic environments, and reporting solutions that support omnichannel use cases.
• Contribute to the broader Insights & Analytics leadership team by shaping standards, best practices, and long‑term capability building in advanced analytics and omnichannel measurement.
• Lead the development of executive‑ready performance readouts, insights summaries, and recommendations for senior leadership.

Decision Making

• The Associate Director will work independently to make decisions related to technical direction, methodologies, approaches on how to address key business questions. Strong collaboration with cross functional teams and robust alignment with Manager will be needed in the identification of Key Business Questions and priorities

Requirements

• Master’s degree (preferred) or bachelor’s degree in business, Analytics, Economics, Data Science, or related field; advanced degree preferred.
• 8–12+ years of experience in pharmaceutical or life sciences analytics, with strong focus on omnichannel, digital, and non‑personal promotion (NPP) measurement.
• Demonstrated experience at the Associate Director or equivalent level, owning analytics products, dashboards, or performance frameworks used by senior leadership and commercial teams.
• Proven expertise in omnichannel and digital engagement analytics, including email, web, media, virtual programs, CRM‑triggered digital, and cross‑channel orchestration.
• Strong understanding of omnichannel measurement and optimization approaches, including segmentation, engagement and response modeling, journey analytics, and channel effectiveness assessment.
• Deep knowledge of commercial pharmaceutical data (sales, claims, CRM, engagement, media, market research) and KPI frameworks.
• Strong leadership and communication skills, with the ability to translate complex analyses into clear, decision‑ready insights for executive audiences.
• Proven cross‑functional collaborator with experience partnering closely with Commercial, Marketing, Digital, Sales Operations, IT, and Data Engineering.
• Experience enabling AI‑ and advanced‑analytics outputs (e.g., segmentation, propensity scores, next‑best‑action) through reporting and insight tools, in partnership with Advanced Analytics teams.
• Demonstrated ability to automate reporting, scale self‑service analytics, and improve speed‑to‑insight while maintaining data quality and governance.

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Legend Biotech is seeking an Associate Director, Performance Reporting, Dashboards & Visualization as part of the CAR-T Operations team based in Bridgewater, NJ.

Role Overview

Performance Reporting, Dashboards & Visualization at Legend enable commercial decision-making through integrated data, intuitive visualization, and scalable performance management solutions. This role serves as the strategic owner of business performance reporting and customer coverage insights, ensuring leaders and field teams have timely, actionable views into execution, reach, and impact.
The Associate Director will lead the evolution of dashboards and reporting products, partner closely with commercial stakeholders to translate business priorities into analytics solutions, and leverage AI-enabled capabilities to modernize reporting, improve self-service, and accelerate insight delivery.
This role focuses on performance measurement, visualization, and reporting enablement, operating in close partnership with Sales Force Effectiveness and Advanced Analytics teams who own optimization and prescriptive decision support.

Key Responsibilities

Business Performance

• Own enterprise performance reporting, ensuring consistent, trusted views into commercial execution across Activated Centers and the community.
• Integrate multiple pharmaceutical data sources (e.g., sales, claims, engagement, and research data) to deliver comprehensive, descriptive insights into customer activity and patient dynamics across the disease journey.
• Partner with Commercial, Marketing, and SFE teams to align on KPI definitions and reporting standards, serving as the single point of ownership for how performance and coverage are measured and visualized.

Dashboards, Visualization & Reporting Products

• Lead the design, delivery, and evolution of dashboards and reporting products, ensuring clarity, usability, and consistency for executive, field, and operational audiences.
• Translate business questions into intuitive visual analytics, enabling stakeholders to quickly understand performance trends, coverage patterns, and execution status without requiring additional analysis.
• Establish visualization and reporting best practices, improving storytelling, consistency, and interpretability across all performance reporting assets.

AI-Enabled Reporting & Automation

• Leverage AI-enabled capabilities to modernize reporting and dashboards, including:
  
  • Automated data refreshes and quality checks
  • Intelligent alerts for material performance changes
  • AI-generated summaries to accelerate interpretation of dashboard outputs
• Drive automation of recurring reporting processes, reducing manual effort, improving reliability, and shortening time-to-insight for leadership and field teams.
• Continuously evolve the reporting ecosystem to keep pace with business needs while maintaining clarity of ownership and role boundaries.

Decision Making

• Will work independently to make decisions related to technical direction, methodologies, approaches on how to address key business questions. Strong collaboration with cross functional teams and robust alignment with Manager will be needed in the identification of Key Business Questions and priorities.

Requirements

• Master’s degree (preferred) or Bachelor’s degree in Business, Analytics, Economics, Data Science, or related field; advanced degree preferred.
• 8–12+ years of experience in pharmaceutical or life sciences analytics, with a strong focus on business performance reporting, dashboards, and visualization.
• Demonstrated experience operating at an associate director level, owning reporting products used by leadership and field teams.
• Deep expertise in commercial performance reporting, KPI frameworks, and customer coverage visibility.
• Strong understanding of pharmaceutical data sources (sales, claims, engagement, market research) from a reporting and insights perspective.
• AI-Enabled Reporting & Automation
  
  • Proven ability to automate recurring reporting processes and scale self-service analytics while maintaining data quality and governance.
  • Comfort partnering with Advanced Analytics teams to operationalize outputs into dashboards, without owning model development.
• Leadership & Communication
  
  • Strong ability to translate complex data into clear, decision-ready insights for senior leadership.
  • Excellent written and verbal communication skills, with experience delivering executive-level presentations.
  • Proven cross-functional collaborator, partnering effectively with Commercial, Marketing, Sales Force Effectiveness, IT, and Data Engineering teams.
• Advanced proficiency in data visualization and dashboarding tools (e.g., Power BI or equivalent), with a strong emphasis on clarity, usability, and executive storytelling.
• Experience leveraging AI-enabled capabilities to enhance reporting efficiency and insight delivery (e.g., automated alerts, summaries, anomaly highlighting).

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Legend Biotech is seeking a Leadership Excellence & Acceleration Pathway Associate as part of the Commercial team based in Bridgewater, NJ.

Role Overview

The Leadership Excellence & Acceleration Pathway (LEAP) Associate is a selective, high-impact role designed to accelerate the development of the next generation of commercial leaders at Legend Biotech.

LEAP Associates participate in a structured, end-to-end commercial development experience spanning key commercial functions, paired with real accountability, senior leader exposure, and hands-on ownership of meaningful business work. The program is intentionally designed for high-potential professionals who have demonstrated strong execution, leadership maturity, and a desire to grow into broader commercial leadership roles within biotech.

Unlike traditional entry-level or functional roles, LEAP Associates are positioned as enterprise-minded contributors, expected to think strategically, execute rigorously, operate across functions, and continuously elevate how work gets done, including through modern, AI-enabled ways of working.

Upon successful completion, participants are expected to be ready for expanded-scope commercial roles within the organization.

Program Overview

• 18-24 month structured rotational development program.
• Exposure across core commercial functions such as: Field Sales, Marketing, Market Access.
• Embedded learning curriculum focused on:
  • End-to-end commercial strategy and execution.
  • Cross-functional leadership and influence.
  • Decision-making in complex, data-rich environments.
  • Responsible and practical application of AI in commercial work.
  • Ongoing mentorship, performance feedback, and senior leader engagement.

(Specific rotation assignments and sequencing will be determined based on business priorities and developmental needs.)

Key Responsibilities

• Across the program, LEAP Associates will be expected to:
• Drive execution by contributing to priority commercial initiatives and business-critical projects across functions.
• Translate strategy into action, supporting planning, analysis, and execution efforts that directly impact commercial performance.
• Operate cross-functionally, effectively partnering with Sales, Marketing, Market Access, Commercial Operations, and other stakeholders.
• Bring structure and insight to ambiguity, using data, judgment, and stakeholder input to support sound decision-making.
• Demonstrate ownership and accountability for outcomes—not just deliverables.
• Build influence without authority, navigating complex stakeholder environments with professionalism and credibility.
• Continuously elevate ways of working, including identifying opportunities to improve efficiency, rigor, and scalability.

AI-Enabled Ways of Working

A core expectation of the LEAP program is the development of applied AI fluency. LEAP Associates will:

• Leverage approved AI tools to support:
  • Commercial analysis and insight generation.
  • Planning and scenario evaluation.
  • Content development and communication.
  • Workflow efficiency and execution effectiveness.
• Apply AI responsibly and in alignment with company governance and standards.
• Identify and share best practices for integrating AI into everyday commercial work.
• Help translate AI-enabled capabilities to teams and stakeholders, supporting broader adoption and impact.

AI is treated as a practical leadership capability, not a theoretical skillset.

Requirements

Required:

• Bachelor’s degree.
• 5–7 years of professional experience.
• Demonstrated track record of execution, ownership, and results delivery.
• Strong analytical, communication, and problem-solving skills.
• Interest in biotech/pharma and commercial leadership pathways.

Preferred:

• Experience in disciplined, performance-driven environments (e.g., military service or similarly structured settings).
• Exposure to commercial, operational, analytical, or customer-facing roles.
• Experience using data, analytics, digital tools, or AI-enabled solutions to support decision-making.
• Comfort working in complex, matrixed organizations.

Developmental Opportunities:

• Exposure to senior leadership.
• Cross-functional rotations.
• Mentorship and coaching.
• Potential placement into full-time commercial roles upon program completion.

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Legend Biotech is seeking participants for Legend's Commercial Management Leadership Development Program as part of the Commercial team based in Somerset, NJ.

Role Overview

The Early Career Leadership Program at Legend Biotech is a strategic, enterprise-focused development experience designed to accelerate the growth of high-potential professionals early in their careers. Rooted in our commitment to cultivating enterprise-minded, value-driven leaders, this program provides structured rotational exposure, executive mentorship, and real-time business impact across scientific, operational, and corporate functions.

Join us in redefining what’s possible and build a career where your growth and patient impact go hand in hand.

Key Responsibilities

• The Commercial Management Hi-Po Leadership Development Program at Legend Biotech is a 2–3-year enterprise leadership accelerator designed for high-potential MBA graduates who aspire to shape the future of biotech commercialization. This program develops leaders capable of translating scientific innovation into meaningful patient access and market impact.
• Participants will complete three strategic rotations (8–12 months each) that may include Marketing, Market Access & Branding, Commercial Operations, Sales, and Business Insights & Analytics. Rotations are designed to provide both broad commercial exposure and the opportunity to pursue areas aligned with individual interests and development goals. Participants will develop the strategic, analytical, and leadership capabilities needed to influence commercial strategy and drive business growth
• This structured program integrates high-impact business experiences, executive mentorship, and a Leadership Development Series focused on developing leaders at every level — from leading self and others to influencing senior stakeholders and driving enterprise-wide business outcomes.
• At Legend Biotech, we believe our people are our greatest asset. This program reflects our unwavering commitment to professional development, career mobility, and long-term leadership growth; empowering early-career talent to take on meaningful challenges, expand their impact, and shape the future of our organization.

Requirements

• Recent MBA graduate (Class of 2023–2026)
• 3-5 years of professional experience demonstrating analytical and leadership capability.
• Background in life sciences, healthcare, marketing, sales, business analytics, or management consulting preferred.
• Strong analytical, communication, and strategic problem-solving skills.
• Demonstrated leadership potential and aspiration to grow into future commercial and enterprise leadership roles.

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Business Development Representative

Location: Northern New Jersey | Type: Full-time | Schedule: Monday–Friday

Are you ready to combine your passion for healthcare with your talent for building relationships? At IVX Health, we are transforming the way infusion and injection therapy is delivered for patients with chronic conditions like Rheumatoid Arthritis, Crohn’s Disease, and Multiple Sclerosis. We are looking for a driven, relationship-focused Business Development Representative (BDR) to expand our presence nationwide by connecting healthcare providers and patients to a better infusion care experience.

If you’re passionate about making a real difference in the lives of patients while achieving professional success, this is the opportunity for you!

About the Role: 

The Business Development Representative is an essential part of the Sales team at IVX Health, dedicated to broadening our impact within the healthcare sector. This role centers on engaging daily with healthcare professionals such as physicians, nurses, and staff at partner hospitals and clinics. The primary aim is to introduce these providers to our ambulatory infusion services, cultivating relationships that facilitate patient referrals.

 Key Responsibilities:

• Territory Growth & Referral Development
  • Identify and engage potential referral sources to increase new patient encounters.
  • Develop and execute strategic sales plans to meet growth targets within the assigned territory.
  • Build and maintain strong relationships with medical practices, clinics, hospitals, and health systems to drive referral volume.
  • Participate in community events and local engagements to increase brand awareness and referral opportunities.
• Provider Engagement & Education
  • Conduct in-person and virtual presentations and educational sessions with healthcare providers and office staff.
  • Serve as a knowledgeable resource regarding IVX Health services, referral processes, and patient experience.
  • Act as a liaison between referring practices and IVX operations teams to ensure a positive experience for both providers and patients.
• Market Intelligence & Performance Tracking
  • Monitor competitor activity, market trends, and territory performance, providing insights to leadership.
  • Analyze sales data and market insights to identify opportunities for growth and improvement.
  • Maintain accurate, timely documentation of activities, leads, expenses, and reporting within CRM and internal systems.
• Cross-Functional Collaboration
  • Partner with Regional Operations, Prior Authorization, Intake, and other internal teams to support smooth patient onboarding.
  • Collaborate with Marketing to promote local events and territory initiatives, including social media engagement.
  • Build relationships with pharmaceutical representatives and other industry stakeholders.
• Professional Development & Compliance
  • Participate in sales meetings, training sessions, and performance reviews to strengthen skills and product knowledge.
  • Maintain current knowledge of healthcare regulations, compliance standards, and industry best practices.
  • Uphold the highest ethical standards in all interactions in alignment with IVX Health values.

Why You'll Love IVX Health

At IVX Health, we believe in taking care of our team just as much as we take care of our patients. Here’s what we offer:

• Comprehensive Healthcare: Medical, dental, and vision coverage, plus telemedicine services.
• Flexible Savings Options: Health Savings Accounts (HSA) and Health Reimbursement Arrangements (HRA).
• Family Support: Fertility and family-building resources.
• Professional Development: Tuition reimbursement, CEU access, and career advancement opportunities.
• Generous Benefits: Disability coverage, life insurance, 401(k) matching, charitable giving programs, and referral bonuses.
• Work-Life Balance: Paid volunteer time and an inclusive, supportive culture.

Required Competencies and Skills:

• Working knowledge of managed care plans, insurance carriers, referral processes, and precertification workflows
• Strong communication and customer service skills with a relationship-driven approach
• Competitive mindset balanced with a patient- and provider-focused perspective
• Strong organizational skills and attention to detail
• Ability to collaborate effectively across internal teams and external partners
• Proficiency with standard office software and CRM systems
• Travel within the assigned territory is required

Education and Experience

• Bachelor’s degree in Business Management, Healthcare Management, or a related field, or equivalent relevant professional experience
• Minimum of 2 years of sales experience, preferably in healthcare or pharmaceutical sales
• Interest in or experience within healthcare, pharmaceutical, or infusion services preferred

Business Development Manager

Location: South Jersey | Type: Full-time | Schedule: Monday–Friday

Are you ready to combine your passion for healthcare with your talent for building relationships? At IVX Health, we are transforming the way infusion and injection therapy is delivered for patients with chronic conditions like Rheumatoid Arthritis, Crohn’s Disease, and Multiple Sclerosis. We are looking for a driven, relationship-focused Business Development Manager (BDM) to expand our presence nationwide by connecting healthcare providers and patients to a better infusion care experience.

If you’re passionate about making a real difference in the lives of patients while achieving professional success, this is the opportunity for you!

About the Role

The Business Development Manager (BDM) is a critical part of the IVX Health team, serving as the face of our organization. This is a Monday through Friday, road warrior role, focused on traveling within the assigned territory to visit referring providers at their brick-and-mortar locations. The BDM will work directly with referral coordinators, physicians, nurses, and healthcare providers to educate them on our services, build meaningful relationships, and drive referrals for infusion therapy patients.

We Are Looking For Someone Who

• Thrives on Building Relationships: You’re a natural networker who enjoys connecting with healthcare providers and becoming a trusted advisor.
• Is Driven to Succeed: You have a competitive spirit and take pride in achieving and exceeding goals.
• Makes an Impact: You’re passionate about healthcare and want to play a key role in improving the patient experience.
• Is a Strategic Thinker: You enjoy creating tailored solutions and strategies to grow a market and expand relationships.
• Loves to Collaborate: You work well with teams, from providers and pharmaceutical reps to internal colleagues, to drive results.

Key Responsibilities

• Develop Long-Term Provider Relationships: Build and nurture trust-based relationships with healthcare providers, ensuring they view IVX Health as a valued partner in patient care.
• Consultative Sales Approach: Focus on relationship-building rather than transactional selling. Educate providers about IVX Health’s benefits and how we can support their patients’ infusion therapy needs over the long term.
• Strategic Growth: Increase patient referrals by fostering deep connections with providers, identifying new referral sources, and attending local networking events.
• Targeted Outreach: Engage with specialists such as rheumatology, gastroenterology, and neurology, positioning yourself as a trusted advisor rather than a one-time sales representative.
• Community Engagement: Plan and execute local events, such as grab-and-go luncheons and office drop-ins, to strengthen provider relationships and enhance brand awareness.
• Collaborate with Teams: Work closely with the marketing team to share local events and patient engagement stories, and maintain active social media visibility to support relationship development.
• Liaison Between Providers and Operations: Act as a key resource to ensure a seamless onboarding experience for referring practices and their patients.
• Industry Partnerships: Build collaborative relationships with pharmaceutical reps and other stakeholders to support a consistent and trusted referral pipeline.
• Stay Organized: Utilize CRM tools as a strategic resource to plan, organize, and strategize sales efforts, ensuring accurate and timely records are maintained in reporting platforms.

Why You'll Love IVX Health

At IVX Health, we believe in taking care of our team just as much as we take care of our patients. Here’s what we offer:

• Comprehensive Healthcare: Medical, dental, and vision coverage, plus telemedicine services.
• Flexible Savings Options: Health Savings Accounts (HSA) and Health Reimbursement Arrangements (HRA).
• Family Support: Fertility and family-building resources.
• Professional Development: Tuition reimbursement, CEU access, and career advancement opportunities.
• Generous Benefits: Disability coverage, life insurance, 401(k) matching, charitable giving programs, and referral bonuses.
• Work-Life Balance: Paid volunteer time and an inclusive, supportive culture.

ESSENTIAL COMPETENCIES AND SKILLS

• Healthcare Expertise: Strong working knowledge of managed care plans, insurance carriers, referral and precertification processes, and documentation guidelines.
• Industry Knowledge: Interest or experience in the pharmaceutical and/or healthcare industry is highly desirable.
• Customer-Centric Mindset: Exceptional customer service skills with a competitive, customer-focused attitude.
• Organizational Excellence: Outstanding organizational skills and meticulous attention to detail.
• Collaborative Spirit: Proven ability to effectively collaborate with internal teams and external stakeholders at all levels.
• Technical Proficiency: Proficient in standard office software applications, including Internet browsers, Outlook, and Microsoft Office Suite.

REQUIRED EDUCATION AND EXPERIENCE

• Educational Background: Bachelor’s Degree in Business or a related field, or equivalent years of relevant experience.
• Healthcare Collaboration: Experience working directly with physicians, nurses, and clinical staff.
• Sales Experience: Knowledge or experience in home health, hospice, DME, or imaging sales is a plus.

Job Summary

The Business Development Manager (BDM) – IG Therapy will be responsible for driving growth in IVIG (Intravenous Immunoglobulin) and SCIG therapies across targeted call points and payers types. This role is therapy-specific and focused on expanding IVX Health’s footprint in the IVIG space by cultivating relationships with referring providers, identifying new IVIG opportunities, and executing strategic sales initiatives. The BDM will work closely with market BDMs & BDRs, payer access, and specialty pharmacy and operations teams to ensure seamless patient onboarding and therapy delivery.

Key Responsibilities

• Market Expansion & Referral Development
• Identify and engage net new IVIG referring providers, including specialists in neurology, immunology, and oncology.
• Expand existing IVIG accounts and develop new ones in designated territories.
• Maintain a consistent IVIG-focused presence in provider conversations to drive awareness and referrals.

• Sales Strategy & Execution
• Implement refined selling motions tailored to IVIG therapies, including therapy-agnostic order forms and product-specific initiatives (e.g., Gamunex-C).
• Collaborate with ASM and Growth leadership to align on territory goals, sales targets, and performance metrics.
• Participate in retraining programs focused on IG sales approaches and reimbursement strategies.

• Cross-Functional Collaboration
• Partner with Prior Authorization (PA) and Intake teams to deploy preferred product matrices and streamline onboarding.
• Coordinate with Clinical and Operations teams to ensure patient onboarding and provider support.
• Support market level collaboration with pharma partners (e.g., Octapharma, Takeda).

• Data & Reporting
• Utilize CRM systems (e.g., Sugar) to track referral activity, account status, and sales performance.
• Provide feedback on market trends, competitor activity, and therapy adoption to inform strategic decisions.

Qualifications

• Proven experience in specialty pharmaceutical sales, preferably in IVIG or related infusion therapies.
• Strong understanding of the IG market, including Part B and Part D dynamics, reimbursement models, and provider behaviors.
• Demonstrated success in opening new accounts and driving therapy-specific growth.
• Excellent communication, presentation, and relationship-building skills.
• Ability to work independently and collaboratively across cross-functional teams.
• Familiarity with CRM platforms and data-driven sales reporting.

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

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.

Job Scope:

A leading biologics and CGT CDMO company in rapid expansion seeks a Senior Procurement Manager. The role focuses on designing strategies for optimal cost control, enhancing vendor management, achieving significant cost savings, and improving procurement sourcing and efficiency. Responsibilities include delivering insights to the executive team, standardizing business methodologies, evaluating procurement processes, and identifying improvement areas.

Responsibilities:

1. Take full responsibility for the end-to-end procurement management of different categories, include but not limit to material, services, equipment, engineering and etc.
2. Align the Purchasing team's goals with organizational objectives, address complex issues by focusing on the needs of internal and external stakeholders to enhance sourcing and procurement processes, in line with global initiatives.
3. Develop, evaluate and maintain qualified supplier resources, and establish long-term partnerships with key suppliers, conduct regular supplier audit and performance evaluations.
4. Negotiate and manage purchasing contracts to improve key terms including price, payment terms, delivery lead time, quality standards and after-sales service, ensure quality and mitigate risks.
5. Coordinate and resolve the issues during the procurement process, including delivery delays, unqualified quality, return and replacement of the goods, to ensure the continuity of the company’s production.
6. Responsible for implementation of purchasing control policy, development of working instructions and guidelines for users on how to deploy it, continuously drive process improvement.
7. Responsible for team building, staff training, develop KPIs and performance evaluations.
8. Manage the daily work of procurement team, formulate teamwork plans and objectives, guide subordinates in supplier development, price inquiry and comparison, contract signing and other work, and improve the overall professional procurement capabilities of the team.
9. Strictly comply with relevant pharmaceutical regulations (cGMP, FDA) and the company’s internal procurement system to ensure the compliance of procurement processes and prevent procurement risk.

Qualifications:

1. Bachelor's degree or above in Business, Supply Chain Management, Engineering, or related field.
2. At least 10 years of procurement experience in biotech/pharmaceutical/CDMO, with expertise in cGMP procurement and regulatory compliance ((FDA/EMA, ICH Q7). 
3. Proven ability to negotiate with vendors for favorable terms and cost reductions.
4. Proficiency in supply chain planning, forecasting demand, and managing inventory lead time to meet business needs.
5. Data-driven decision maker with exceptional leadership and communication skills, capable of setting clear visions and strategies.
6. Experience in leading multi-cultural teams, valuing diversity, and navigating global business dynamics.
7. Excellent technical skills, proficient in Excel, Word, PowerPoint, Project and SAP/S2P(Ariba or GEP) systems.
8. Expertise in strategic sourcing, evaluating and qualifying suppliers to optimize cost, quality, and supply reliability is preferred
9. CPSM (Certified Professional in Supply Management) or Six Sigma Green Belt is preferred

The salary range for the role is 120k - 160k depending on experience and skill set

#PB

#LW

Incentive Trips:

• Help project manage annual incentive trip calendar, timelines, and budgets; track expenses, and reconcile upon program completion
• Support research and recommendations for extraordinary destinations and venues
• Plan and execute memorable on-the-ground experiences for attendees, including group meals, outings, and activities
• Brainstorm and source attendee gifts and gifting experiences
• Oversee attendee travel arrangements to ensure a VIP experience
• Provide on-site support to ensure an optimal attendee experience
• Track winner awards and rewards; report relevant information to Acadia Finance to ensure compliance with internal policies and procedures

Congresses & Conferences:

• Provide occasional on-the-ground support for medical congresses and conferences in support of Acadia’s congress-planning leads

Education/Experience/Skills:

Bachelor’s degree or an equivalent combination of relevant education and applicable job experience. A minimum of 5+ years’ experience in the pharmaceutical or biotechnology industries in progressively responsible meeting planning positions, including meetings, congresses, and incentive trips.

Must possess:

• Certified Meeting Professional (CMP) designation
• Cvent certification or comparable experience with Cvent Event Management, Attendee Hub, and Venue Sourcing modules
• Experience independently managing pre to post-event requirements for internal meetings of 30 – 50 attendees; Experience supporting meeting planning for internal meetings of 250+ attendees
• Strong written and verbal communication skills
• MS Office proficiency in Copilot, Outlook, Word, PowerPoint and Excel
• Understanding of Regulatory, Legal and Medical requirements for pharmaceutical marketing/events
• Effective interpersonal skills and the ability to lead without authority
• Strong organizational abilities and detail orientation
• Ability to prioritize effectively to manage multiple programs at one time
• Excellent budget management skills
• Experience negotiating hotel contracts
• Self-direction and a sense of urgency
• Flexibility, adaptability, and solution-orientation; able to pivot without skipping a beat
• Ability to thrive in an environment of growth and continual improvement

#LI-HYBRID #LI-CA1

Department: Client Services

Job type: Full Time, Exempt

Who We Are

Impiricus is the first and only AI-powered HCP Engagement Engine. In 2025, Deloitte named Impiricus the #1 fastest growing company in North America for their prestigious Fast 500 list. Founded by a practicing physician and a senior pharmaceutical executive, Impiricus was created to transform how life sciences companies support physicians. We ethically connect HCPs to pharma resources, reduce go-to-market costs and accelerate patient access to the treatments they need.

With our unique access to the largest opted-in network of HCPs, their insights, and clinical expertise, we are the leading provider of AI technology and real-time channels that life science companies need to deliver clear, reliable, and evidence-based resources directly into the hands of HCPs. Guided by a council of 2000+ trusted HCP advisors, we ensure every interaction is clinically meaningful, ethically grounded and leads to better patient care.

Job Summary

The Enterprise Account Director is a senior strategic leader responsible for end-to-end success and growth of 2–3 high-value enterprise accounts ($10-20M in annual revenue). This role goes beyond traditional account management — the Enterprise Account Director serves as a trusted consulting partner to client executives, deeply understands their long-term business goals, and ensures that all programs, governance, and delivery activities are aligned to achieving these priorities. The ideal candidate consistently safeguards delivery quality, drives cross-brand coordination, champions structured governance, and leads proactive performance insights that deliver measurable business outcomes.

This role requires both a strategic mindset and strong operational excellence — the Enterprise Account Director is ultimately accountable for high-quality, on-time delivery of all customer programs while building strong executive relationships that drive retention, expansion, and strategic impact

Duties/ Responsibilities: 

This role operates as the enterprise-level leader above brand-level program execution. While not directly managing project resources, the Enterprise Account Director is accountable for all delivery quality and holds the cross-functional team responsible.

Account Leadership & Strategic Partnership

• Serve as the primary executive-level point of contact for assigned enterprise customers.
• Develop a deep understanding of each customer’s business, strategic priorities, and success metrics.
• Act as a consultative advisor — not just a delivery manager — guiding clients toward optimal outcomes.
• Partner with internal teams (CS, Sales, Product, Delivery, Analytics) to continually elevate value delivered: consistently on-time, on budget, and exceeding customer expectations.

Cross-Brand Coordination & Governance

• Lead cross-brand coordination across multiple internal teams, ensuring aligned execution across programs.
• Establish and run structured governance rituals, steering committees, and executive forums with clients.
• Contribute to stakeholder mapping across commercial, medical, IT, and compliance 
• Standardize quarterly planning, risk escalation, and decision pipelines to support predictable delivery outcomes.
• Ownership of escalations and paths to resolution

Project Delivery Oversight

• Provide oversight for your accounts to ensure delivery quality and timeliness for all customer initiatives.
• Partner with project managers to set and maintain clear scopes, milestones, quality baselines, and risk plans.
• Monitor delivery performance at tactical and strategic levels, ensuring commitments are met.

Metrics, QBRs & Performance Readouts

• Define and track success metrics aligned to customer goals, translating activity into impact.
• Lead Quarterly Business Reviews (QBRs) and executive readouts that synthesize performance, insights, and forward plans.
• Continuously monitor progress and drive corrective actions to exceed performance expectations.
• Accountable for ensuring performance readouts clearly demonstrate business impact and ROI at the executive level

Revenue & Growth Stewardship

• Responsible for customer keeping high NRR
• Support sales in protecting and growing revenue through value delivery, renewal planning, and expanded opportunities.
• Identify strategic expansion opportunities and partner with Sales to capture them.
• Serve as the internal voice of the customer, influencing product and solution roadmaps.

Experience:

• 8+ years of experience in enterprise account management, client success, consulting, or strategic delivery leadership.
• Proven experience owning large enterprise customer relationships with revenues in the $20M range.
• Experience leading strategy and partnership with pharma clients
• Excellent executive presence with ability to engage senior stakeholders and influence cross-functional internal teams.
• Strong operational and project delivery skills, with a track record of driving quality and on-time execution.
• Expertise in governance, performance metrics, and structured client reporting.
• Consultative mindset — ability to understand customer business goals and translate them into actionable delivery plans.
• Excellent and refined communication skills (written, verbal, presentation) tailored to both operational and executive audiences.
• Strong project management and time management skills
• A self-starter that turns ambiguity into clarity and direction. 

The base salary range for this role is $180,000 - $200,000

Where you land within the range will reflect your skills, experience, and location, while keeping team parity in mind and leaving room for future growth.

Important Notice

To protect candidates, please note that all communication from our team will come directly from an @impiricus.com email address. We do not engage third party recruiters to schedule interviews for this role. If you receive outreach from anyone outside of our domain claiming to represent Impiricus, please disregard and let us know by forwarding the message to careers@impiricus.com

Benefits:

Impiricus focuses on taking care of our teammates’ professional and personal growth and well-being.

 Healthcare: Medical, dental, and vision coverage for you and your dependents + on-demand healthcare concierge
 HSA, FSA & DCFSA: Pre-tax savings options for healthcare and dependent care, with monthly employer contributions to HSA (if enrolled in a high-deductible plan)
 Coverage & Protection: 100% paid short- and long-term disability, plus life and AD&D insurance
 Flexible Time Off: Take the time you need with a flexible vacation policy — recharge your batteries your way
Parental Leave: Paid parental leave to spend time with your newborn, adopted, or foster child (available after 6 months)
 Your Work, Your Way: If you’re close to an office, we encourage spending some time in-person to collaborate and connect. If not, remote is always an option.
 Home Office Setup: We’ll ship you the gear you need to create a comfortable workspace at home.
 401(k): Save for your future with tax advantages (and company match!)

Impiricus provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

About Us

Nourish is on a mission to improve people’s health by making it easy to eat well. Nutrition-related chronic disease is the largest and most overlooked crisis in the world. Food can be medicine: working with a Registered Dietitian is one of the most effective interventions available, but <1% of eligible Americans use their covered benefits.

Nourish is building an AI-native, patient-friendly healthcare system centered on nutrition that improves outcomes, lowers costs, and helps people live healthier, longer lives. We launched three years ago, are live in all 50 states, and already have thousands of dietitians and hundreds of thousands of patients on the platform.

We are growing quickly, have partnered with national health insurance companies and provider groups, and have raised $115M from top-tier VCs including JP Morgan Growth Equity, Thrive Capital, Index Ventures, Y Combinator, Maverick Ventures, Box Group, Atomico, G Squared, and Pinegrove Venture Partners. Our angel investors include world-class healthcare founders from Oscar, Rightway Health, Headway, Spring Health, and Alto Pharmacy, as well as soccer star Alex Morgan and the founders from Olipop and Notion.

Learn more about us here and read about our recent Series B here.

About the Role

As a Provider Partnerships Senior Manager (PPSM), you’ll be instrumental in advancing our mission to improve health outcomes by making nutrition care accessible to more patients. This is a provider-facing field role where your primary goal is to grow patient referrals to Nourish by building and nurturing relationships with healthcare providers and their teams — including primary care physicians, specialists, medical assistants, and office managers.

Your impact will be felt every day: by putting patients first, championing providers as partners, and ensuring more people gain access to life-changing nutrition support. In this role, you’ll report directly to a Provider Partnerships Regional Manager and join a fast-moving, values-driven team.

Please note: This is a full-time role and you must be located in Central Jersey (Middlesex, Trenton, Plainsboro, Princeton).

Key Responsibilities:

In this role, you’ll take full ownership of growing your territory and building lasting provider partnerships. You’ll have both the autonomy and support to approach the work creatively and effectively, with a clear focus on driving patient impact. Core responsibilities include:

• Field Engagement: Spend ~5 days per week in the field, meeting with providers within an approximately 1-hour driving radius of your territory.
• Spotting Opportunities: Proactively research, prospect, and identify new provider partners.
• Connecting & Converting: Build trust and credibility with leads, converting them into referral partners who rely on Nourish for their patients’ nutrition care.
• Fostering Relationships: Develop authentic, long-term relationships not only with providers but also with clinic staff — including medical assistants, office managers, and administrators — ensuring the entire office is engaged in supporting patient referrals.
• Contributing to Growth: Help shape the Provider Partnerships function by refining processes, creating resources, and sharing best practices that strengthen the team.

You’ll love this role if:

• You’re passionate about Nourish’s mission. You care deeply about improving healthcare access and believe nutrition is a vital part of the solution.
• You have a knack for building strong relationships. Building trust comes naturally to you, and you thrive on creating meaningful relationships at every level of a practice.
• You are relentlessly resourceful. You see challenges as opportunities, bringing both grit and creativity to every situation. Your resilience allows you to turn obstacles into opportunities.
• You embrace ownership. You’re self-driven, proactive, and comfortable stepping into ambiguity to figure things out, even when it means stepping outside of your comfort zone.
• You thrive in a fast-paced, dynamic environment. Change excites you - you adapt quickly and stay focused on results, while being flexible in your approach.
• You welcome coaching and feedback. You see growth as a team sport, and you’re motivated by learning and continuous improvement.
• You work with focus and intention. You know how to work hard and optimize your time, maximizing impact and driving meaningful results.

We’d love to hear from you if:

• You have proven success in a provider-facing field sales role (pharmaceutical, medical device, or healthcare industry strongly preferred).
• You have demonstrated ability to independently build and grow a territory from the ground up with strategic ownership.
• You have a strong professional presence and the ability to influence and connect across the entire office - from physicians to medical assistants, office managers, and staff.
• You have proficiency with CRM software (Salesforce preferred) and a comfort with quickly learning new systems.
• You have exceptional communication skills (written and verbal), with strong time management and organizational abilities.

Compensation & Field-Based Benefits

• Our Compensation Philosophy
• Competitive base salary + uncapped monthly variable compensation
• Mileage & wear/tear reimbursement at IRS standard rate
• $65/month cell phone reimbursement
• $125/quarter WFH stipend (home office setup)
• Company card for field expenses (breakfasts, lunches, provider engagement, etc.)
• Comprehensive health, dental, and vision coverage

Please note: You must be legally authorized to work in the U.S. for this position.

More Information

Mission & Vision & Success
Nourish Clinical Philosophy
Values
Why Nourish Exists
How We Work

About Us

Nourish is on a mission to improve people’s health by making it easy to eat well. Nutrition-related chronic disease is the largest and most overlooked crisis in the world. Food can be medicine: working with a Registered Dietitian is one of the most effective interventions available, but <1% of eligible Americans use their covered benefits.

Nourish is building an AI-native, patient-friendly healthcare system centered on nutrition that improves outcomes, lowers costs, and helps people live healthier, longer lives. We launched three years ago, are live in all 50 states, and already have thousands of dietitians and hundreds of thousands of patients on the platform.

We are growing quickly, have partnered with national health insurance companies and provider groups, and have raised $115M from top-tier VCs including JP Morgan Growth Equity, Thrive Capital, Index Ventures, Y Combinator, Maverick Ventures, Box Group, Atomico, G Squared, and Pinegrove Venture Partners. Our angel investors include world-class healthcare founders from Oscar, Rightway Health, Headway, Spring Health, and Alto Pharmacy, as well as soccer star Alex Morgan and the founders from Olipop and Notion.

Learn more about us here and read about our recent Series B here.

About the Role

As a Provider Partnerships Senior Manager (PPSM), you’ll be instrumental in advancing our mission to improve health outcomes by making nutrition care accessible to more patients. This is a provider-facing field role where your primary goal is to grow patient referrals to Nourish by building and nurturing relationships with healthcare providers and their teams — including primary care physicians, specialists, medical assistants, and office managers.

Your impact will be felt every day: by putting patients first, championing providers as partners, and ensuring more people gain access to life-changing nutrition support. In this role, you’ll report directly to a Provider Partnerships Regional Manager and join a fast-moving, values-driven team.

Please note: This is a full-time role and you must be located in North Jersey (Passaic, Wayne, Ridgewood, Bergen).

Key Responsibilities:

In this role, you’ll take full ownership of growing your territory and building lasting provider partnerships. You’ll have both the autonomy and support to approach the work creatively and effectively, with a clear focus on driving patient impact. Core responsibilities include:

• Field Engagement: Spend ~4 days per week in the field, meeting with providers within an approximately 1-hour driving radius of your territory.
• Spotting Opportunities: Proactively research, prospect, and identify new provider partners.
• Connecting & Converting: Build trust and credibility with leads, converting them into referral partners who rely on Nourish for their patients’ nutrition care.
• Fostering Relationships: Develop authentic, long-term relationships not only with providers but also with clinic staff — including medical assistants, office managers, and administrators — ensuring the entire office is engaged in supporting patient referrals.
• Contributing to Growth: Help shape the Provider Partnerships function by refining processes, creating resources, and sharing best practices that strengthen the team.

You’ll love this role if:

• You’re passionate about Nourish’s mission. You care deeply about improving healthcare access and believe nutrition is a vital part of the solution.
• You have a knack for building strong relationships. Building trust comes naturally to you, and you thrive on creating meaningful relationships at every level of a practice.
• You are relentlessly resourceful. You see challenges as opportunities, bringing both grit and creativity to every situation. Your resilience allows you to turn obstacles into opportunities.
• You embrace ownership. You’re self-driven, proactive, and comfortable stepping into ambiguity to figure things out, even when it means stepping outside of your comfort zone.
• You thrive in a fast-paced, dynamic environment. Change excites you - you adapt quickly and stay focused on results, while being flexible in your approach.
• You welcome coaching and feedback. You see growth as a team sport, and you’re motivated by learning and continuous improvement.
• You work with focus and intention. You know how to work hard and optimize your time, maximizing impact and driving meaningful results.

We’d love to hear from you if:

• You have proven success in a provider-facing field sales role (pharmaceutical, medical device, or healthcare industry strongly preferred).
• You have demonstrated ability to independently build and grow a territory from the ground up with strategic ownership.
• You have a strong professional presence and the ability to influence and connect across the entire office - from physicians to medical assistants, office managers, and staff.
• You have proficiency with CRM software (Salesforce preferred) and a comfort with quickly learning new systems.
• You have exceptional communication skills (written and verbal), with strong time management and organizational abilities.

Compensation & Field-Based Benefits

• Our Compensation Philosophy
• Competitive base salary + uncapped monthly variable compensation
• Mileage & wear/tear reimbursement at IRS standard rate
• $65/month cell phone reimbursement
• $125/quarter WFH stipend (home office setup)
• Company card for field expenses (breakfasts, lunches, provider engagement, etc.)
• Comprehensive health, dental, and vision coverage

Please note: You must be legally authorized to work in the U.S. for this position.

More Information

Mission & Vision & Success
Nourish Clinical Philosophy
Values
Why Nourish Exists
How We Work

National Director of Sales & Business Development – Pharmaceutical Finished Dosage (OTC & Rx)

Remote | Travel Required

Garonit Pharmaceutical is seeking a high-performing National Director of Sales & Business Development to drive growth across our expanding finished dosage portfolio (OTC & Rx).

This is a key commercial leadership role focused on building new business, expanding strategic accounts, and driving revenue growth across healthcare systems, distributors, retail chains, and contract manufacturing/private label partners.

What You’ll Do

• Drive revenue growth across OTC and Rx finished dosage products
  • Identify, develop, and close new business opportunities across:
   – National & regional retail chains (including private label)
   – Healthcare systems / hospitals
   – Pharmaceutical distributors
   – CMO/CDMO partnerships
  • Own the full sales cycle from prospecting through contract execution
  • Build and expand key accounts and long-term partnerships
  • Lead pricing strategy, contract negotiations, and commercial agreements
  • Monitor market trends, competitive activity, and pricing dynamics
  • Provide strategic insights on customer needs, market access, and new product opportunities
  • Support go-to-market strategies for new product launches
  • Maintain pipeline, forecasting, and reporting in CRM (Salesforce)

What We’re Looking For

• Bachelor’s degree required (Business, Life Sciences, or related field preferred)
• 5–10 years of pharmaceutical sales experience
  • Experience with finished dosage products (tablets, liquids, topicals, etc.)
  • Exposure to both OTC and Rx markets preferred
  • Proven track record of achieving or exceeding sales targets
  • Experience selling into retail, distributors, healthcare systems, or CMO/CDMO partners
  • Strong commercial acumen and ability to manage complex sales cycles
  • Excellent communication, negotiation, and presentation skills
  • Self-driven, entrepreneurial mindset

Why Join Garonit?

• Rapidly growing pharmaceutical company with expanding finished dosage capabilities
  • Opportunity to play a key role in shaping commercial strategy and growth
  • Competitive base salary + performance-based bonus/commission
  • High visibility with leadership and strong advancement potential

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

Please note that this position is based in Princeton, NJ or San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary:

The Director, Marketing will contribute to the development of the overall Consumer strategy of the brand while leading the management and execution of marketing tactics, plans and activities to promote the brand to caregivers. This role is responsible for shaping patient and caregiver messaging across channels, including direct-to-consumer (DTC) television advertising and educational materials, while ensuring alignment with brand strategy, regulatory standards, and patient-centric principles. The Director will deliver impactful communications that meaningfully engage the caregiver community, and will play a key leadership role within the consumer marketing team. This role will partner across key stakeholders (advocacy, medical affairs, regulatory, legal, compliance, patient services, market access, marketing operations, training, sales, etc.) to execute the programs and tactics identified in the brand plan.

Primary Responsibilities:

• Lead the development and execution of consumer and caregiver marketing initiatives, including core messaging, direct-to-consumer (DTC) television advertising, and educational materials designed to inform, support, and empower families within the Rett community.
• Oversee the caregiver speaker program, including speaker identification, onboarding, and management; development of compliant, engaging speaker content; and ongoing evaluation and optimization of program effectiveness.
• Ensure caregiver speaker materials and presentations are scientifically accurate, compliant, and aligned with brand strategy, with a strong emphasis on clarity, empathy, and patient- and caregiver-focused storytelling.
• Serve as the primary marketing liaison to the Family Support Educator (FSE) team, ensuring alignment between consumer marketing initiatives and field-based educational efforts to deliver a cohesive and consistent caregiver experience.
• Directs the development of strategic marketing programs for inclusion into brand plan, determines metrics for program success, and evaluates performance against metrics including contributions to the development and evolution of message strategy based upon in-depth analytics and ROI analysis. Manages within the established the US promotions budget for assigned products.
• Represents the department as a member of cross-functional project teams providing guidance, insight, and recommendations relative to the goals and objectives of the Marketing function to ensure strategic alignment medical education messaging across groups.
• Monitors and ensures that all Medical Legal Review (MLR) processes are followed, and all programs are compliant with legal guidance and corporate policies.
• Implements the brand strategy for products and product lines. Develops and delivers presentations as needed to commercial management and other internal groups. Monitors progress of plans and recommends adjustments, as necessary.
• Develops and maintains strong external relationships with Advocacy groups, physician speakers and Rett caregivers and families.
• Mentor and develop junior team members by providing clear direction, coaching, and constructive feedback, fostering strong marketing fundamentals, professional growth, and a collaborative, high-performing team culture.Lead day-to-day collaboration with the advertising agency of record, providing strategic direction and hands-on oversight across creative development and execution to ensure consumer-facing campaigns are aligned with brand strategy, patient-centric principles, timelines, and budget.

Education & Experience:

• Bachelor’s degree in marketing, health care, life science; master’s degree preferred.
• Targeting 10+ years of progressively responsible experience in pharmaceutical or biotech Marketing.
• 5+ years in a product manager role strongly desired.
• Launch experience and commercialization of new products preferred.

Required Skills:

• Rare Disease experience is highly desirable, with requirement of understanding specialty therapeutics addressing significant unmet medical needs.
• Strong Biopharmaceutical brand management experience and demonstrated track record of success.
• Proficient in marketing and media tactics directed towards HCPs and caregivers.
• Proficient at effectively prioritizing goals and coordinating resources to achieve those goals.
• Demonstrated ability to interface/collaborate with other departments as necessary to achieve goals.
• Significant travel required; ability to travel up to 50% of time during peak launch time periods.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently overnight up to 25% of the time and work after hours if required by travel schedule or business issues.

#LI-SM1 #LI-HYBRID

Please note that this position can be based in Princeton, NJ, San Diego, CA, or San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Sr. Director, Commercial Advanced Analytics & Data Strategy is a strategic leadership role responsible for defining, building, and scaling the analytics capabilities, data strategy, and governance frameworks that enable commercial decision-making across the organization. This role ensures that high quality data, advanced analytics, and AI enabled insights are seamlessly integrated into commercial strategy, planning, launch execution, and in market optimization.  The Sr. Director serves as a strategic partner cross-functionally, translating business priorities into scalable analytics products and platforms while ensuring governance, compliance, and measurable business impact.

Over time, this role will build and mature commercial advanced analytics and data capabilities, establish fit‑for‑purpose operating models, and define future talent and capability needs to support the evolving business. The role will work closely with Acadia’s AI team, which provides shared AI expertise across Commercial and R&D, as well as with IT teams responsible for enterprise data, infrastructure, and platform enablement.

Primary Responsibilities

Commercial Analytics Strategy & Leadership

• Partner with Commercial leadership to define the advance analytics vision, strategy and initiatives that enables the development of scalable analytics and decision-support capabilities that drive business outcomes

• Lead and govern advanced analytics projects, predictive analytics, and AI/machine learning solutions  supporting brand strategy, launch planning, patient support, segmentation, targeting, omnichannel optimization, and sales effectiveness.

• Enable AI-driven commercial use cases such as next-best-action, customer engagement optimization, automated forecasting, and scenario planning.

• Balance innovation with rigor by ensuring analytics solutions are interpretable, validated, and compliant with internal and external requirements including privacy laws

• Translate commercial business questions into analytics use cases, models, and decision frameworks.

• Ensure analytics outputs and insights are actionable, adopted, and embedded into commercial planning, existing workflows, processes, systems and demonstrate measurable outcomes.

• Act as a trusted advisor to Commercial leadership, influencing decisions through data-driven insights

• Partner with the Enterprise AI team to identify, prioritize, and scale high-value AI and advanced analytic capabilities, solutions and governance.

Data Strategy, Governance and Cross-Functional Enablement Leadership

• Establish commercial data strategy to support the organization in achieving its business objectives. This includes leading the acquisition, implementation, and evolution of the commercial data assets, including syndicated claims, EMR, prescription, HUB/SP/Partner, promotional, and digital data.

• Partner cross-functionally with Enterprise Data, IT, and infrastructure teams to enable scalable data platforms, data pipelines, and tools that support analytics, AI, and self-service insights.

• Oversee vendor selection and management for data sources, analytics tools, and platforms.

• Establish governance frameworks for data access, analytics validation, and model lifecycle management.

• Collaborate with legal/compliance teams to mitigate risk and ensure compliance with HIPAA, GDPR, CCPA, and internal data privacy and security policies.

• Partner with IT data and infrastructure teams to align commercial analytics needs with enterprise architecture, platform standards, security requirements, and long-term data strategy.

Leadership & Communication

• Serve as a bridge between business stakeholders and technical teams, ensuring clarity of requirements and outcomes.

• Influence senior executives through concise storytelling, visualization, and business impact measurement.

• Build, lead, retain and mentor a high-performing team and capability in support of advanced analytics, data acquisition, and data governance, while fostering a culture of accountability, continuous improvement, and innovation.

• Assess and evolve organizational capabilities, talent, and ways of working needed to scale commercial advanced analytics over time.

• Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in data science, statistics, engineering, computer science, or a related field; Advanced degree (MS, PhD, or MBA) preferred.  Targeting 12 years of progressively responsible experience in commercial analytics, data science, or data infrastructure data strategy, or related functions, with significant experience in biotech or pharmaceutical organizations.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Advanced analytics, modeling, and visualization tool experience (AI/ML, predictive analytics (Python), SQL, R and PowerBI).

• Experience working with modern data platforms and cloud technologies (e.g., Snowflake, Databricks, DataRobot, Dataiku, AWS, Azure, GCP).

• Deep experience and understanding of commercial datasets, data environments, and data vendors (including Hub, Specialty Pharmacy, patient services, Veeva CRM, syndicated claims, prescriptions, payer, social media/website, Google, Facebook etc.).

• Proven ability to lead cross-functional AI/ML and Analytical initiatives and influence senior stakeholders and to drive adoption of analytic solutions.

• Solid understanding of pharmaceutical commercialization concepts including launches, brand planning, and lifecycle management.

• Demonstrated experience in leading data governance initiatives and processes.

• Demonstrated ability to design and communicate complex systems and analytical solutions to both technical and non-technical audiences, aligning resources and execution to achieve functional and enterprise goals.

• Proven abilities with executive-level communication, data storytelling, and change leadership.

• Demonstrated impact of analytics on commercial strategy, decision making, performance, and ROI.

• Proven ability to lead, coach, and develop talent while building organizational capability in a fast-evolving environment.

• Experience partnering effectively with cross-functional partners and business stakeholders to deliver scalable analytics solutions.

• Ability to balance strategic vision with hands-on prioritization and execution in fast past environment.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #LI-CA1

Please note that this position can be based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Senior Manager, Field Force Effectiveness, will support Acadia’s commercial field teams within the Neuroscience franchise with strategic insights and data-driven recommendations. This role is critical in helping sales leadership to drive performance, identify opportunities within local geographies and support deployment strategies, including targeting, alignment and call-plan. This individual will collaborate closely with Sales, Marketing, Patient Support Services, and other cross-functional teams to help shape commercial decisions.The ideal candidate combines strong analytical capabilities with deep commercial understanding and the ability to influence cross-functional stakeholders in a highly regulated environment.

Primary Responsibilities

• Analyze sales performance, promotional effectiveness, and sub-national market trends to inform commercial sales leadership on strategy, tactics, and business planning activities
• Optimize targeting & segmentation (HCPs, IDNs, accounts)
• Align field activity with brand strategy and lifecycle priorities
• Evaluate and refine reach/frequency and HCP engagement models
• Provide insights on territory performance, sales force effectiveness, and targeting optimization to support field force initiatives
• Collaborate across functions on strategic Omnichannel Campaigns and/or triggers, working closely with Field, Marketing, IT and Advanced Analytics
• Work with large datasets (e.g., internal HUB/SP, IQVIA, claims data, etc.) to develop & enhance dashboards, KPIs, business reports, presentations and run ad-hoc analysis
• Collaborate with field leadership on the administration and execution of sales force deployment activities including processing territory alignments, targeting, and call-planning efforts
• Support Brand Planning and Business Reviews, by partnering with field leadership and Neuroscience Brand teams
• Conduct pre/post analysis of field initiatives, field activities, and local market dynamics to assess impact and ROI
• Maintain data integrity and ensure alignment with compliance and regulatory standards
• Implement advanced analytics (predictive modeling, next-best-action)
• Translate data into clear, actionable insights for leadership and reps
• Perform other duties as assigned

Education/Experience/Skills

Bachelor’s degree in Data Science, Business, Economics, Statistics, Life Sciences or related field. Targeting 6+ years of progressively responsible experience in analytics or business insights within the pharmaceutical or biotech industry. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Strong analytical skills with experience working with pharmaceutical data sets (e.g., internal HUB/SP, IQVIA XPT/DDD, Longitudinal claims data, CRM)
• Advance Proficiency in Excel, SQL, and BI tools such as Power BI, Tableau
• Working knowledge of sales operations, field force structure, marketing operations and/or commercial models in pharmaceuticals
• Strong communication with the ability to translate data into actionable business insights
• Experience collaborating cross-functionally with Sales, Marketing, Market Access, and Patient Services
• Strong project management and organizational skills
• Experience with CRM and analytics tools (e.g., Veeva CRM, BI tools)
• Experience in specialty or rare disease pharmaceutical markets is strongly desired
• Knowledge of data privacy regulations and compliance in healthcare analytics
• Must be able to travel domestically on occasion

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #LI-CA1

Job Summary

The Ocular Surgery Account Manager (OSAM) is responsible for growing business with Harrow-approved products with a strong focus on expanding sales in a defined geographic region, reporting to the National Sales Director, Ocular Surgery. This position requires a highly motivated self-starter with strong business acumen who offers solutions to challenges, has a positive presence with internal and external customers, is well organized, and can multitask in a continuously changing and dynamic ophthalmic surgery (or surgical) environment. Assigned monthly/quarterly/annual sales revenue and product objectives are achieved through consultation and value-based communications with ophthalmologists, surgery centers, and staff on the use, characteristics, and advantages of Harrow peri-operative products. Prospective candidates should have a proven track record of success in managing peri-operative therapies, managing relationships between a physician’s office and their ASC, buy-and-bill sales, and working in a highly collaborative matrix environment.   

Core Responsibilities

• Takes 100% ownership, with an entrepreneurial mindset, to meet or exceed quarterly sales revenue and product goals
• Ability to effectively communicate complex clinical information to ophthalmic surgeons, billers, and administration in both the surgeon’s office and ASC
• Adept understanding of complex care systems and strong capability to assess local dynamics to inform area business growth acceleration plans  
• Solid understanding of reimbursement concepts as they relate to buy and bill
• Develop critical physician and ASC staff relationships within the assigned geography 
• Utilizes all internal resources when developing quarterly action plans or handling problem accounts
• Provides weekly new business forecasts and updates
• All sales activity is adequately recorded in CRM
• Maintain an in-depth and professional level understanding of the Harrow surgical peri-operative products
• Collaborate effectively with internal departments and peers
• Act with a sense of urgency at all levels of customer care and follow up
• Ability to travel throughout the assigned geography on a routine basis
• Utilize the designated CRM system – Salesforce
• Understand and follow all industry and company policies and guidelines
• Comply with all state and federal legislation and regulatory requirements
• Manage expenses in a thoughtful, responsible, and ethical manner
• Resourceful thinker that may not have a complete roadmap to success, but finds the resources available to win and prosper
• Acts as the liaison for customer complaints or issues with continual follow-up
• Submits all required reports, including monthly expense reports, on time 
• Competent in PowerPoint, Excel, Word & Outlook

Qualifications & Requirements

• Bachelor’s degree in a related field
• Has 3+ years of successful ophthalmology sales experience with buy and bill sales and/or ophthalmic medical device sales experience preferred.
• Ability to build, develop, and foster longstanding relationships with customers 
• Ability to quickly absorb product and practice information and offer solutions that resonate
• Experience with the execution of strategic and targeted business plans around priorities and goals
• Proficient with MS Office products, including Word, Excel, and PowerPoint
• Knowledge of how physicians make decisions regarding patient care for various therapies
• Excellent presentation and interpersonal skills
• Solid independent judgment and initiative required
• Superior communication and written skills are a must
• Ability to multitask, adjusting priorities as needed
• Good problem-solving and analytical skills
• Ability to become proficient with Salesforce CRM

Position Type

• Remote

Travel

• Expected travel in the field will be about 100% which will include overnight stays which is less than 75%

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

Position Overview 

The Head of Data Center Selection and Strategy is a passionate and entrepreneurial leader responsible for seeking data center solution sales and guiding infrastructure selection for our clients. This role requires expertise in data center facilities and high-level technology with a proven ability to identify, pursue, and secure enterprise client opportunities. This role will leverage their strong market knowledge and subject matter expertise to build relationships with data center real estate brokers, data center colocation providers and prospective clients. Success in this position requires strategic vision and the ability to manage and engage various parties for success. 

Candidates should demonstrate a comprehensive understanding of the data center market, critical system assessments, site selection, lease negotiations and transaction oversight. Experience working with high-profile enterprise clients, industry-leading brokerage firms and operators is highly valued. This role will be expected to conduct market research, advise clients on strategic outcomes, and deliver client-focused solutions that drive business growth and profitability. 

The ideal candidate will possess at least ten years of experience in the data center arena, with a minimum of five years focused on data center or technology real estate. Prior professional services experience, and a proven track record of entrepreneurial success are highly recommended. This role must be able to communicate effectively at all levels, mentor internal talent, and collaborate across teams to ensure seamless integration and shared objectives. 

Key Responsibilities

• Demonstrate expertise in data center infrastructure, with a comprehensive understanding of enterprise clients and the complexities involved in improving their environments. Experience spans from the data center space to the physical layer of technology, offering expert guidance and tailored solutions aimed at upgrading client portfolios. 
• Build trusted advisor relationships with clients; communicate effectively at all levels within client organization (Board-level to DC Manager level); demonstrate knowledge and experience to be credible across DC environments.  
• Assessment Guidance: Incorporate Align’s value by introducing our assessment abilities to determine site capacities for clients. Assist with strategic planning. 
•  Site Identification & Analysis: Work with the team to pinpoint locations and sites of interest for potential clients 
• Stakeholder Engagement: Establish and nurture relationships data center owners,  data center brokers and data center colo providers 
• Negotiation & Agreement Management: Lead discussions for Align services including; assessments, site selection, design, plan, procure, build and execute 
• Portfolio Strategy: Advise clients on existing data center capacities, technology portfolio optimization to identify significant savings and value-add opportunities. 
• Transaction Oversight: Manage all aspects of leasing transactions, including tenant representation, landlord agency leasing, and marketing. 
• Market Research: Conduct market research to identify trends, opportunities, and risks in the data center real estate sector. 
• Project Management: Track milestones and ensure timely execution of site/infrastructure development strategies. 

Qualifications

• Experience: Minimum 10 years in the data center arena, with at least 5 years focused on data center or technology real estate. 
• Expertise: Understanding of the data center market, portfolio management, and transaction processes. 
• Industry Knowledge: Familiarity with major data center brokerage firms and operator. 
• Skills: Exceptional negotiation, relationship-building, and project management skills. 
• Education: Bachelor’s degree in Real Estate, Business, Engineering, or related field; advanced degree preferred. 
• Entrepreneurial Mindset: Demonstrated ability to drive business growth and deliver client-focused solutions. 

To support a fair, consistent, and high-quality hiring experience, some interviews may be recorded. These recordings help our team focus fully on the conversation at hand, rather than note-taking, and allow us to better evaluate and improve our recruitment process. Recordings are used solely for internal purposes such as training, quality assurance, and process improvement. Candidates will be informed in advance and asked to provide consent before any recording takes place.

Position Overview 

The Head of Data Center Selection and Strategy is a passionate and entrepreneurial leader responsible for seeking data center solution sales and guiding infrastructure selection for our clients. This role requires expertise in data center facilities and high-level technology with a proven ability to identify, pursue, and secure enterprise client opportunities. This role will leverage their strong market knowledge and subject matter expertise to build relationships with data center real estate brokers, data center colocation providers and prospective clients. Success in this position requires strategic vision and the ability to manage and engage various parties for success. 

Candidates should demonstrate a comprehensive understanding of the data center market, critical system assessments, site selection, lease negotiations and transaction oversight. Experience working with high-profile enterprise clients, industry-leading brokerage firms and operators is highly valued. This role will be expected to conduct market research, advise clients on strategic outcomes, and deliver client-focused solutions that drive business growth and profitability. 

The ideal candidate will possess at least ten years of experience in the data center arena, with a minimum of five years focused on data center or technology real estate. Prior professional services experience, and a proven track record of entrepreneurial success are highly recommended. This role must be able to communicate effectively at all levels, mentor internal talent, and collaborate across teams to ensure seamless integration and shared objectives. 

• This is a full-time, salaried position offering $250,000+, full benefits, paid time off, paid training, and performance-based bonuses. 

Key Responsibilities

• Demonstrate expertise in data center infrastructure, with a comprehensive understanding of enterprise clients and the complexities involved in improving their environments. Experience spans from the data center space to the physical layer of technology, offering expert guidance and tailored solutions aimed at upgrading client portfolios. 
• Build trusted advisor relationships with clients; communicate effectively at all levels within client organization (Board-level to DC Manager level); demonstrate knowledge and experience to be credible across DC environments.  
• Assessment Guidance: Incorporate Align’s value by introducing our assessment abilities to determine site capacities for clients. Assist with strategic planning. 
•  Site Identification & Analysis: Work with the team to pinpoint locations and sites of interest for potential clients 
• Stakeholder Engagement: Establish and nurture relationships data center owners,  data center brokers and data center colo providers 
• Negotiation & Agreement Management: Lead discussions for Align services including; assessments, site selection, design, plan, procure, build and execute 
• Portfolio Strategy: Advise clients on existing data center capacities, technology portfolio optimization to identify significant savings and value-add opportunities. 
• Transaction Oversight: Manage all aspects of leasing transactions, including tenant representation, landlord agency leasing, and marketing. 
• Market Research: Conduct market research to identify trends, opportunities, and risks in the data center real estate sector. 
• Project Management: Track milestones and ensure timely execution of site/infrastructure development strategies. 

Qualifications

• Experience: Minimum 10 years in the data center arena, with at least 5 years focused on data center or technology real estate. 
• Expertise: Understanding of the data center market, portfolio management, and transaction processes. 
• Industry Knowledge: Familiarity with major data center brokerage firms and operator. 
• Skills: Exceptional negotiation, relationship-building, and project management skills. 
• Education: Bachelor’s degree in Real Estate, Business, Engineering, or related field; advanced degree preferred. 
• Entrepreneurial Mindset: Demonstrated ability to drive business growth and deliver client-focused solutions. 

To support a fair, consistent, and high-quality hiring experience, some interviews may be recorded. These recordings help our team focus fully on the conversation at hand, rather than note-taking, and allow us to better evaluate and improve our recruitment process. Recordings are used solely for internal purposes such as training, quality assurance, and process improvement. Candidates will be informed in advance and asked to provide consent before any recording takes place.

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

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:

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:

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

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