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 Executive Director, Pipeline Clinical Lead as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Pipeline Clinical Lead is a senior clinical development leader accountable for the scientific and medical direction of early stage clinical programs. This role provides strategic and operational leadership across first in human through proof of concept studies, with accountability for clinical strategy, trial design, execution, interpretation, and regulatory interactions.

The Pipeline Clinical Lead will lead and develop a team of physicians and scientists, work closely with cross functional partners, and collaborate with external development partners and investigators. Deep expertise in clinical trial design, regulatory frameworks, and compliance in drug development—ideally within cell therapy—is essential.

This role requires strong scientific judgment, leadership presence, and a hands on approach in a fast paced, entrepreneurial environment, with a clear focus on patient safety and clinical impact.

Key Responsibilities

Clinical Development Leadership

• Serve as clinical science lead for early stage programs (pre IND through Phase 1/2), including study design, execution, data interpretation, and reporting.
• Define and integrate clinical strategies, including PK/PD, biomarkers, diagnostics, and translational approaches, particularly for cell and gene therapies.
• Provide clinical input into asset selection, review of preclinical data, and development path decisions.

Regulatory & Compliance

• Lead or support IND preparation and amendments, clinical sections of regulatory submissions, and responses to health authority questions.
• Represent the clinical function in pre IND, IND, and (as applicable) BLA/MAA interactions with regulatory agencies.
• Champion patient safety, ethical conduct, and compliance with GCP, corporate policies, and global healthcare regulations.

Cross Functional & External Collaboration

• Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Early Discovery,
• Manufacturing, Biomarkers, and Pharmacovigilance to ensure integrated program delivery.
• Collaborate with external development partners, academic investigators, KOLs, and study sites.
• Act as a credible scientific and clinical representative for programs in internal governance and external forums.

People & Matrix Leadership

• Provide direct line management and mentorship for Medical Directors, Clinical Research Scientists, Medical Writing, Clinical Program management and other clinical staff as applicable.
• Lead effectively in a matrix environment, anticipating cross functional needs and proactively resolving conflicts or risks.
• Contribute clinical leadership to business development, due diligence, and partnership activities when required.

Requirements

• MD or MD PhD (or equivalent) with US board certification or international equivalent.
• ≥8 years of clinical development experience in industry and/or academia, with demonstrated leadership in hematology/oncology.
• Proven experience designing and executing clinical trials from first in human through registrational stages.
• Prior involvement with IND submissions; experience with BLA/MAA filings and health authority meetings strongly preferred.
• Cell therapy and/or CAR T clinical development experience highly desirable IT Skills.
• Strong scientific judgment with the ability to navigate complex clinical and regulatory challenges.
• Demonstrated ability to lead cross functional and geographically distributed teams in a matrix environment.
• Excellent written and oral communication skills, including protocol writing, regulatory documents, publications, and senior level presentations.
• Highly collaborative, influential leader with the ability to represent programs with credibility and confidence.
• Hands on, execution oriented mindset with strong organizational and analytical skills.
• Willingness to travel up to 15–20%.

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Legend Biotech is seeking a Project Manager, External Engagement (Contractor) as part of the Commercial team based in Bridgewater, NJ.

Role Overview

Reporting to Executive Director, External Engagement, the Project Manager will run and manage multiple projects in a proactive manner. Leverage project management tools and processes, including detailed timelines, milestones and daily tracking to ensure projects are delivered to company goals and commitments. Be prepared to report on project progress and status through weekly reporting or at the request of Leadership.

Key Responsibilities

• Define scope, goals, and deliverables of each assigned project that support business goals in collaboration with senior management and stakeholders.
• Develop full-scale project plans and associated communications documents.
• Identify and anticipate potential risks and establish plans to proactively address such potential risks.
• Effectively and proactively communicate project modifications to the impacted parties with explanations of new responsibilities, deadlines, target dates, etc.
• Coordinate with members of the Legal, Compliance, and Medical Affairs departments to ensure concurrence with budgetary, and other legal and compliance requirements.
• Develop and implement procedures, as needed, for project monitoring to include team meetings, action item follow-up, meeting minutes, and identifying new actions and resolutions.
• Coordinate with internal resources to assist with project management and execution.
• Manage workflow requirements and documentation related to the projects.
• Interface with executives/department leads for strategy and budgeting purposes.
• Efficiently manage and maintain a system of problem resolution (i.e., change in project requirements, missed deadlines, etc.). Facilitate resolution of project conflicts by consulting with project teams and stakeholders and developing innovative solutions.
• Weekly Reporting.

Requirements

• Bachelor’s Degree from accredited college or university.
• Two to four years project management experience, or combination of education and experience.
• Two + years’ experience in the pharma/biotechnology industry.
• Initiative-taker.
• Excellent people skills with the ability to lead, engage in focused and clear interactions with stakeholders from a variety of levels, functions, and companies.
• Strong familiarity with project management software, such as Microsoft Project
• Exceptional planning, organization, and execution skills.
• Strong quantitative and analytical skills.
• Demonstrated ability to identify, prioritize, provide resolution options, and escalate critical issues to Executive Leadership, as necessary.
• Demonstrated ability to manage timelines.
• Ability to anticipate and solve problems while analyzing complex issues and environments.
• Demonstrated excellence in project management, while effectively managing multiple projects/priorities.
• Strong oral and written communication skills and an ability to communicate complex concepts in a concise, simplified manner.
• Demonstrated ability to work with and coordinate demands from multiple internal and external stakeholders.
• Ability to effectively prioritize and execute in a high-pressure, milestone-driven, and rapidly changing environment is crucial.
• Exhibition of the highest degree of ethical standards and trustworthiness.

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Legend Biotech is seeking a Program Lead, Cell and Gene Therapy as part of the Global Manufacturing and Supply team based in Raritan, NJ.

Role Overview

The program Lead will be responsible for developing and executing the internal commercial manufacturing strategy for iLVV (in vivo Lentiviral Vector). This role will lead strategic planning, drive execution, propose options to senior leadership, of the commercial manufacturing introduction activities across late-stage and commercial programs, ensuring technical excellence, regulatory readiness, operational execution, and seamless cross-functional alignment. The position requires close collaboration with cross-functional teams including R&D, process development, MSAT, global facility & engineering, Quality, procurement, regulatory affairs, and finance.

Key Responsibilities

Strategic Leadership

• Define and drive the internal commercial manufacturing strategy for iLVV.
• Evaluate internal/external options for iLVV commercial manufacturing, and seek stakeholder feedback.
• Present options and recommendations to senior leadership for decision-making.
• Provide clear, concise, and timely updates to senior management regarding program progress, risks, and strategic considerations.
• Motivate and inspire cross-functional teams, building momentum, alignment, and ownership.
• Make decisive, data-driven, and sometimes tough decisions to advance program objectives under aggressive timelines.

Planning & Execution:

• Develop detailed business and implementation plans and timeline for late stage clinical and commercial manufacturing to deliver launch milestones.
• Oversee facility fitness and readiness and ensure alignment with stakeholders on commercial tech transfer and production timelines.

Cross-Functional Collaboration

• Partner with R&D for process development and technology transfer.
• Work closely with engineering and Somerset facility teams for infrastructure planning.
• Drive decision-making that balances scientific rigor, speed, risk, and business impact.
• Coordinate with regulatory and quality teams to ensure compliance with global standards.
• Collaborate with finance to manage budgets and cost projections.

Process Development & Transfer

• Working with MSAT to drive commercial process transfer activities from development to manufacturing.
• Coordinate generation of process descriptions, control strategies, equipment requirements and Bill of Materials.
• Drive establishment of raw material requirements, QC method readiness and facility fit.
• Ensure robust scale-up and validation of vector manufacturing processes.

Manufacturing Site & Operational Readiness

• Ensure manufacturing facilities are prepared for the new product including capacity, equipment, utilities, and staffing.
• Partner with Supply Chain to secure long-lead materials, single-use components, and critical suppliers.
• Oversee line-of-business readiness: QA, QC, MSAT, warehouse, digital systems, labeling, analytics.
• Align on operational procedures (SOP updates, batch records, deviations/corrective actions).

Quality and Compliance

• Ensure compliance with applicable global GMP, ICH, and regulatory expectations.
• Support CMC submissions, PPQ documentation, change controls, and validation packages.
• Collaborate with Quality to ensure inspection readiness and audit support.

Continuous Improvement & Lifecycle Management

• Identify opportunities to optimize manufacturing robustness, cost, and yield post-launch.
• Implement lessons learned, knowledge management systems, and NPI best practices.
• Support product lifecycle changes such as process improvements, site expansions, and supply chain enhancements.

Requirements

Education

BS is required, Ph.D. preferred in Biotechnology, Biochemical Engineering, or related field.

Experience

• Minimum 10+ years in biopharmaceutical manufacturing. Viral vector late processes development/manufacturing experience is required.
• Proven experience in facility scale and layout planning, and commercial process transfer and validation.
• Strong understanding of cGMP requirements and regulatory frameworks for cell and gene therapy products.

Skills

• Strategic thinking and ability to build consensus among peers and influence senior leadership.
• Excellent project management and cross-functional leadership skills.
• Strong communication and stakeholder management capabilities.
• Ability to thrive in a fast-paced, evolving environment.
• Highly goal-oriented, ownership-driven, and laser-focused on execution.
• Comfortable navigating ambiguity and making quick, high-impact decisions.

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Legend Biotech is seeking a Manager, Competitive Intelligence as part of the Commercial team based in Somerset, NJ.

Role Overview

The of Competitive Intelligence (CI) will serve as a strategic thought partner responsible for generating actionable insights that inform decision-making across R&D, commercial, and corporate strategy functions. This individual will lead proactive and on-demand CI initiatives, including competitor monitoring, landscape assessments, early signal detection, conference surveillance, and strategic analysis that supports pipeline development, lifecycle management, and long-term planning. The ideal candidate is a highly analytical, collaborative, and business-oriented professional with strong communication skills and a deep understanding of the biopharmaceutical landscape.

Key Responsibilities

Strategic Intelligence & Insight Generation

• Lead competitive intelligence activities across assigned therapeutic areas, platforms, and/or programs, delivering high-quality, actionable insights to senior leadership and cross-functional stakeholders.
• Conduct comprehensive landscape assessments, including scientific, clinical, regulatory, and commercial dimensions.
• Monitor competitors’ pipelines, clinical data, regulatory actions, collaborations, and market events to identify emerging threats, opportunities, and early signals.
• Monitor new entrants and startup tracking: Monitoring early innovation signals, investments, and disruptive players
• Synthesize complex data into clear narrative insights and strategic recommendations.

Conference Coverage & Surveillance

• Lead end-to-end conference CI planning and execution, including surveillance plans, abstract triage, onsite (or virtual) monitoring, rapid-readouts, and post-conference summaries.
• Coordinate cross-functional stakeholders to ensure aligned priorities and actionable outputs.

Data & Analysis Leadership

• Build and maintain CI frameworks, dashboards, market landscapes, and tracking systems to support continuous monitoring.
• Manage internally created CI dashboard and in some cases external CI vendors and ensure high-quality deliverables aligned with business needs.
• Develop and implement CI best practices, tools, and standardized processes.

Cross-Functional Partnership

• Serve as CI lead for R&D, commercial, BD, and strategy teams; participate in team meetings and strategic discussions as an insights partner.
• Partner with forecasting, medical affairs, and commercial strategy to ensure cohesive interpretation of external environment dynamics.
• Required to make decisions on a day-to-day operations for their tasks, and technicalities related to CI mostly. 

Requirements

• Master’s in life sciences, business, or related field
• 3+ years of experience in pharmaceutical/biotech competitive intelligence, strategy, consulting, market research.
• Strong scientific and clinical acumen in relevant therapeutic areas; hematology/oncology and Autoimmune experience preferred (if applicable).
• Demonstrated track record of delivering strategic insights and influencing decision-making.
• Strong analytical and strategic thinking abilities.
• Excellent written and verbal communication skills; ability to distill complex information into clear insights.
• Highly proficient in CI methodologies, secondary research, data interpretation, and triangulation.
• Skilled at working in fast-paced, cross-functional environments with tight timelines.
• High integrity and ability to manage sensitive/confidential information.
• Familiarity with CI tools, databases, and information platforms (e.g., Evaluate, Cortellis, Datamonitor, Alphasense, and clinical databases). 

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Legend Biotech is seeking an Associate Director, Operations Program Lead as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Operations Program Lead (OPL), Clinical Operations is accountable for accelerated operational delivery of 1-2 priority cell therapy development programs across all phases. This position is responsible for leading, managing and providing operational oversight for quality delivery within budget across all Legend Pipeline studies for 1-2 assets.

This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. This position requires a high-performing contributor with strong leadership and stakeholder management skills. This individual will collaborate with the cross functional team to develop operationally feasible program timelines and identify clinical trial operational risks and develop mitigation strategies to ensure accelerated and cost-efficient quality clinical trial execution.  In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, and represent the clinical trial operation function at internal and external meetings.

This position will oversee 1-2 contractor Clinical Trial Associates (CTA).

Key Responsibilities

Direct end-to-end clinical trial management: 

• Direct end-to-end clinical trial operations activities domestically and globally: i.e. lead and take ownership in all aspects of Study Operations for CAR-T Studies in a matrix environment.
• Responsible for the overall success of the clinical study programs
• Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Ensures audit-ready condition of clinical trial documentation including central clinical files.
• Report on all aspects of the study progress at a granular level to stakeholders and senior leaders. Effective, consistent & regular tracking of project (s). Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Senior and Mid-level management Study Management Meetings).
• Supports the Development of strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives.
• Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans.
• Define project timelines & deliverables, by working closely with the cross-functional core program team for end-to-end execution of clinical trials.
• Collaborates in the preparation and/or review of study-related documents (e.g., study protocols, informed consents and amendments, Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals).

Clinical Trial Operations Efficiency and optimization:

• The OPL will drive clinical Operations excellence by playing a critical role in Clinical Trial Operations Efficiency and optimization.
• Work with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support optimal and efficient clinical trial execution. 
• The position involves working closely with the clinical development team and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, tech ops, manufacture, supply chain, regulatory, project management, medical affairs, finance, legal and quality.
• Create and Manage study trial execution RACI to support overall trial execution and operational excellence.
• Contribute to Clinical Operations functional initiatives and institution of best practices.

Resource Management and Direct High Performing team:

• Manage and build a high-performing clinical operations support structure. Duties include hiring, onboarding, training, and development of staff to manage studies.
• Lead, develop and manage study operation manual, new work-streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance.
• Provides study-specific training and leadership to clinical research staff, including CRO, sites and other study personnel to support clinical trial execution and optimization.

Direct and Support Vendor Partnership

• Oversee vendor selection process, management, of Contract Research Organizations (CROs) and vendors involved in clinical trial Operation (CRO, Central Lab, etc).
• Participates in CRO and vendor study related calls and meetings, holds team members accountable for actions, escalates issues and oversees all aspects of daily study operations. Ability to identify issues and risks. Develops and manages mitigations and/or escalate risks appropriately.
• Negotiates vendor contracts / budgets and presents to the executive study team for approval.
• Review and confirm CRO and site payment invoices.
• Lead vendor performance assessment for continuous process improvement
• Management/oversight of external vendor deliverables reports and budgets.
• Collaborate within Clinical Operations and with study leadership team to create preferred vendor list for clinical development.

Leadership Skills

• Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream, and lateral implications of decisions that affect study outcomes and timelines.
• Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Excellent team player: willingness and ability to fill functional gaps in a small organization.
• Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities.

Key Relationships

• The Operations Program Lead in Clinical Operations works closely with the asset Core Team and cross-functional teams such as safety, study monitoring, data management, biostatistics, bioanalytics, manufacturing, supply chain, regulatory, project management, medical affairs, and quality.
• Mentoring and management of a CTA.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• Oncology and/or Immunology clinical trial operations therapeutic experience required. 10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience.
• Experience leading the operational planning and oversight of clinical trials as the point of accountability for operational delivery. (CAR-T trials experience is a plus).
• Demonstrated ability to deliver ambitious trial acceleration timelines within a competitive clinical trial landscape.
• Phase 1 clinical trial operational experience is preferred.
• Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements are essential.
• This position requires experience and leading study/project management to create study project plans, and end-to end-study timelines for execution of clinical trials.
• Demonstrated ability to multi-task and manage high performance demands.
• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• CRO/Vendor oversight experience required.
• Project Management (biotech) experience a plus.
• Regulatory authority inspection experience a plus.
• Ability to travel as necessary (approximately 10 – 15 %); both domestically and internationally.
• Effective oral, written and interpersonal communication skills.
• Strong communication and presentation skills.
• Forward and critical thinker.
• SOP development experience preferred.
• Strong organizational and project management skills, and the ability to multitask.
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
• Excellent working knowledge GCP, FDA and ICH Guidelines.

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Legend Biotech is seeking a Head, Business Operations and Alliance Management as part of the Commercial team based in Bridgewater, NJ.

Role Overview

Reporting directly to the President, Carvykti BU, this role serves as the BU’s Strategy & Execution Lead, driving alignment, execution, and operational effectiveness across Commercial, GMS, Quality, and Medical Affairs. A core responsibility is managing Legend’s strategic alliances—ensuring strong governance, seamless communication, and proactive issue resolution so both organizations deliver on joint CAR‑T objectives.

The role also leads BU‑wide engagement and communication, fostering clarity, connection, and cultural cohesion across global teams. In parallel, it drives capability building, strengthening organizational readiness, talent development, and cross‑functional effectiveness to support Carvykti’s rapid growth and strategic priorities.

Key Responsibilities

Alliance Management:

• Lead governance of current and future alliances, ensuring transparent communication, shared accountability, and timely escalation.
• Coordinate joint steering committees, joint working teams, and governance bodies to ensure compliance with collaboration agreements and delivery on shared milestones.
• Maintain a strong relationship with partner organizations (e.g., Janssen) and serve as a central connective point between Carvykti BU functional stakeholders and alliance partners.
• Proactively identify risks, misalignments, or emerging strategic opportunities within collaborations and drive resolution or acceleration initiatives.
• Ensure open communication channels across both organizations and consistent partnership health tracking.

Engagement & Communication:

• Drive engagement initiatives and forums - town halls, BU business reviews, culture initiatives, leader communications, and cross‑functional alignment sessions.
• Serve as a strategic advisor to the BU President on messaging, engagement cadence, and organizational pulse.
• Design and lead BU‑level internal communications strategy, ensuring clarity, transparency, and alignment from the President through LT‑1 and field/operational teams.

Innovation & Strategy Acceleration:

• Partner with BU President & LT to shape and drive BU strategic initiatives, including transformation, digital capability scaling, operational innovation, and cross‑functional initiatives.
• Monitor industry trends (CAR‑T evolution, regulatory updates, partnership models) and translate insights into BU priorities.

Capability Building:

• Support BU‑wide capability strategy (technical, leadership, and operational), to ensure teams are equipped for current and future needs across Commercial, GMS, Quality, and Medical Affairs.
• Build mechanisms to measure capability maturity and organizational effectiveness.
• Partner with HRBP, OD, and Functional Heads to design learning ecosystems and talent acceleration pathways.
• The Head, Business Operations and Alliance Mgmt. exercises independent decision-making authority across strategic and operational domains, including project scope, timelines, resource allocation, and vendor selection. Decisions related to significant budget changes, strategic shifts, or major collaborations require higher-level approvals. This role is expected to proactively identify issues, propose solutions, and guide cross-functional execution with minimal oversight.

Requirements

• Advanced degree (MBA, MS) preferred; background in cell therapy, biotech, strategy, or operations strongly desirable.
• 10+ years’ in Pharma / Biotech with experience in alliance management, strategy execution, business operations and cross-functional leadership.
• Demonstrated success managing high‑complexity external partnerships and governance structures.
• Experience working with or leading within matrix organizations across Commercial, GMS, Quality, and Medical Affairs is highly desirable.
• Proven track record in driving organizational capability building, communication strategies, or enterprise‑level initiatives.
• Strong written and verbal communication skills; executive‑level presence.
• Strategic systems thinker with ability to distill complexity and drive clarity.
• Exceptional stakeholder management and influence.
• Strong program management, change management, and problem‑solving capability.
• High agility, ability to manage ambiguity, and proactive issue resolution.
• Culturally intelligent and globally collaborative.

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Legend Biotech is seeking a Sr. Director, Clinical Operations Capabilities and Standards as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Director, Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost-effective scalability of the Clinical Operations department. 

Among other responsibilities, this position will establish, oversee and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations; including managing and developing staff within each pillar.

This position will also be the company subject-matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.

Key Responsibilities

Oversee the development and strengthening of the following clinical operations capabilities and functions, with leads/teams in each of these areas:

Clinical Trial Planning & Analytics:

• Clinical Trial Planning and Analytics (CTP&A) is accountable for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs.
• This function provides data‑driven feasibility insights to enable informed decision‑making during early study planning and partners closely with Clinical Operations Leads, Clinical Development, cross-functional stakeholders and external vendors to ensure trials are designed and placed for successful execution.
• This function is responsible for predictive trial performance modeling to enable proactive implementation of contingency plans

Clinical Trial Operational Technologies:

• The Clinical Trial Operations Technology function is responsible for the strategic ownership, governance, and optimization of clinical trial operations systems that enable compliant, efficient, and inspection‑ready execution of clinical trials.
• This function serves as the business owner for core clinical systems (e.g., CTMS, eTMF, and related platforms), ensuring alignment with clinical operations needs, regulatory requirements, and the company’s development portfolio. The position partners closely with Clinical Operations Leads, Quality, Regulatory, Data Management, IT, and CROs/external vendors.
• Areas of focus for capability building include leveraging technology to enable cost-efficient trial budget builds and ongoing costs optimization during study execution, enabling tools for targeted clinical operations risk management and technology-enabled eTMF oversight.

Vendor Alliance Management:

• Vendor Alliance Management is responsible for the strategic and operational oversight of external clinical operations vendors and CRO partners supporting clinical trials, including coordination of vendor due diligence for vendor qualification. Ensures vendors deliver high‑quality services in compliance with GxP and contractual expectations, while enabling efficient study execution across one or more clinical programs.
• Vendor Alliance Management is the primary interface between internal Clinical Operations Program Leads and external service providers, with accountability for vendor governance, performance management via objective metrics, issue escalation, and continuous improvement.

Site contracts and Payments

• Site Contracts & Payments is responsible for creating and overseeing a scalable and effective operating model for site contracting visibility, investigator payment operations, serving as a central point of accountability for improving operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor-CRO-site workflow alignment.

Sample and Imaging Management Operations

• Sample and Imaging Management is responsible for end-to-end sample and imaging oversight across Legend pipeline studies. To strengthen visibility, accountability, and coordination across sites, CROs, central labs, specialty labs, imaging vendors.
• Sample and Imaging Management focuses on system‑level consistency and risk reduction, mitigating against loss of patient data, enabling acceleration of data cleaning and reducing site burden for participation in clinical trials.
• Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related SOPs and guidance documents.
• Performs other duties as required.

Key Relationships

• The Head of Clinical Operations Capabilities and Standards works closely with all applicable internal cross-functional leaders and teams as well as external vendors for the clinical operations capability building and strengthening.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• 12+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership responsibility across global clinical development programs.
• Significant experience in establishing, scaling, or transforming centralized Clinical Operations capabilities, including one or more of the following:
  • Clinical Trial Planning & Analytics / Feasibility
  • Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms)
  • Vendor Alliance Management
  • Site Contracts and Investigator Payments
  • Sample and Imaging Management Operations
• Proven expertise in end‑to‑end clinical trial conduct, including early‑phase through late‑phase trials, with strong understanding of protocol development, feasibility, start‑up, execution, and close‑out.
• Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
• Experience acting as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices applied across multiple studies or programs.
• Strong background collaborating with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions in a matrixed global environment.
• Experience participating in and/or supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct is strongly preferred.
• Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders.
• Willingness to travel as required (approximately 10%).
• Deep knowledge of clinical trial operations frameworks, including industry best practices and regulatory expectations (ICH‑GCP, FDA, and global health authorities).
• Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.
• Demonstrated leadership in clinical operations technology enablement, including business ownership of systems (e.g., CTMS, eTMF), data quality oversight, technology‑enabled risk management, and inspection readiness.
• Expertise in vendor and alliance management, including development of governance structures, KPI frameworks, financial oversight, and performance optimization.
• Understanding of clinical trial sample, imaging, and data flows, with ability to design operational controls that reduce patient data risk, site burden, and cycle times.
• Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance.
• Proven strategic and critical thinking skills, with a data‑driven mindset and ability to anticipate operational risks and mitigation strategies.
• Strong experience developing, authoring, and governing clinical operations SOPs, standards, and guidance documents.
• Exceptional communication, presentation, and stakeholder influence skills, with the ability to engage senior leadership and cross‑functional teams.
• High proficiency with clinical operations–relevant technologies and tools, including MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for operational decision‑making.

#Li-AS1

#Li-Hybrid

This role is a Hybrid Role: Employees are expected to work from our Kenilworth, NJ office 3 days per week and may work remotely the remaining days

Senior Manager, Quality Assurance

Description:

The Senior Quality Manager, OTC Program is responsible for the leadership, governance, and continuous improvement of the company’s Over-the-counter (OTC) quality program for cosmetic and OTC products. This role ensures full compliance with applicable FDA regulations and internal quality standards across product development, manufacturing, testing, release, and post market activities.

The position serves as the Quality subject matter expert for OTC regulatory requirements and provides strategic and operational leadership to ensure consistent implementation of OTC program guidelines across internal sites and third-party manufacturers.

Key responsibilities:

OTC Quality Program Leadership

• Own and continuously improve OTC Quality Program guidelines, standards, and governance aligned with FDA requirements (21 CFR Parts 201, 210, 211, as applicable) and Health Canada requirements to ensure compliance and inspection readiness.
• Serve as the primary Quality point of contact and SME for OTC regulatory/compliance matters, including MoCRA rollout and regulatory milestone execution.

Quality Compliance & Oversight

• Ensure OTC products are manufactured, tested, labeled, released, and distributed in compliance with FDA requirements and internal QMS standards, providing lifecycle oversight (change control, deviations, investigations, CAPAs, and product disposition).
• Lead or support FDA inspections and internal/external audits for OTC products, ensuring timely closure of observations.

Quality Systems Integration

• Integrate OTC requirements into the QMS (validation, supplier quality, complaints, stability, documentation) and define/oversee validation strategies for OTC products, processes, equipment, and computerized systems.
• Partner with QC, Regulatory Affairs, Manufacturing, R&D, and Supply Chain to apply OTC quality requirements consistently.

Third-Party Manufacturing & Supplier Quality

• Provide quality oversight to third-party manufacturers, laboratories, and suppliers supporting OTC products, including qualification, auditing, and performance monitoring to maintain compliance.

OTC Drug Stability Program

• Lead a team of individual contributors to ensure compliance with annual and accelerated stability testing, including authoring, review, and approval of stability protocols and final reports.

Leadership & Cross-Functional Collaboration

• Lead, mentor, and develop team members supporting OTC activities, and provide training/guidance to cross-functional teams on OTC quality and regulatory expectations; reinforce a culture of compliance and accountability.
• Influence senior stakeholders to enable timely, compliant, risk-based decisions.

Risk Management & Continuous Improvement

• Identify OTC quality/compliance risks, monitor regulatory trends and enforcement activity, assess impact, and implement effective mitigation plans and program updates.
• Lead continuous improvement to strengthen compliance, efficiency, and inspection readiness.

25% travel required (mainly in USA)

Required Competencies, Skills & Experience

• Bachelor's degree in chemistry, Pharmacy, Life Sciences, Engineering, or related scientific discipline.
• Minimum 7+ years of experience in Quality Assurance or Quality Management within the cosmetic, pharmaceutical, or consumer health industry.
• Strong, demonstrated knowledge of FDA OTC regulations and quality system requirements.
• Proven experience supporting FDA inspections and managing OTC related‑ quality programs.
• Demonstrated leadership skills with the ability to influence cross functional‑ and senior stakeholders.

• ASQ certifications desirable, Business coursework, Six Sigma Teachings, desirable

Knowledge & Skills:

• Experience working in a global organization with third-party manufacturing networks.
• Prior experience acting as the Quality lead or SME for OTC programs during regulatory inspections.
• OTC regulatory and quality expertise
• Strong leadership and decision-making skills
• Excellent written and verbal communication
• Risk based thinking and attention to detail
• Ability to operate effectively in a matrixed, global environment

Revlon is unable to sponsor or transfer employment visas for this role; candidates must be legally authorized to work in the United States without current or future visa support.

The base pay range for this position is $120,000.00 - $150,000.00 / year; however base pay offered may vary depending on skills, experience, job-related knowledge, and geographic location. Certain positions may also be eligible for short-term incentives as part of total compensation.

Employees (and their families) are eligible for medical, dental, and vision benefits. Employees are covered by the company-paid basic life insurance policy and company-paid short-term disability insurance (the benefit commences upon hire and allows for a portion of base salary for up to 26 weeks if you are disabled). Other benefits offered to employees include but are not limited to the following: long-term disability, supplemental life insurances, flexible spending accounts, critical illness insurance, group legal, identity theft protection, etc. Employees are also able to enroll in our 401k Retirement Savings Plan.

Employees will also receive 3 weeks of vacation, pro-rated based on date of hire for the 1st year of employment and twelve paid holidays throughout the calendar year. Vacation will depend on role.

#LI-Hybrid #LI-EM1

Real Chemistry is looking for a Account Manager/Senior Account Manager join our growing team!   

The Account Manager/Senior Account Manager for the Scientific and Medical Affairs is the client’s key day-to-day contact, managing relationships and helping to set their expectations of the agency. You make sure that your colleagues know what is going on and are delivering effectively. You are thinking about future opportunities as well as today’s work.   

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do:  

• Day-to-day client contact: provide regular status updates to your client; respond to client queries and share recommendations (following discussion with your account lead); manage client expectations on timelines, scope of project, etc.; take client briefs and clearly communicate to team members, implementing realistic project plans  
• Take responsibility for the day-to-day management of your account, including managing the processes of the account (including running regular internal team meetings), flow of work, delegation of tasks (oversee status reports to ensure all team actions are complete) and the status of jobs across the account (not just your own)  
• Ownership of and accountability for medium/large client projects, ensuring that projects are delivered to highest possible standards within budget and agreed timeframes  
• Ongoing communication with your account lead on the progress of projects; alerting them to any barriers to project completion and being proactive in making recommendations and proposing solutions on how to proceed  
• Awareness of the client’s business priorities and a sound understanding of the program strategy; have a good understanding of competitor activity  
• Keep abreast of trends and developments in the medical communications and pharma industries  
• Start to identify areas for growth (evolving existing programs and/or additional tactics), proactively sharing new ideas with your team and client  
• Keep abreast of market changes  
• Be proactive when new business opportunities arise, flagging relevant experience and areas of interest, contributing thoughts and ideas, assisting in the production of credentials and pitch presentations  
• Maintains general understanding of account finances; supports account lead with financial management  
• Support new business research and ideation, participate in pitch presentations as required 
• Continued professional development engagement; work with manager to identify training opportunities based on areas of interest and need  

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.  
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.  
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.  
• You are a highly organized self-starter, able to work independently and under tight deadlines.  

What you should have:   

• A minimum of 3 years of prior experience in healthcare agency client services roles with medical affairs, publications, and/or medical information experience required 
• Highly organized with a mindfulness of deadlines, the ability to manage multiple tasks based on priorities and a strong attention to detail  
• Independent thinker confident in taking ownership of assets and material development, but a team player who enjoys collaboration  
• Professional presence, performs with a sense of urgency and with a client service orientation  
• Has confidence to manage upward when required; able to communicate with managers when deadlines will not be met or when issues are foreseeable  
• High energy, able to effectively operate in fast-paced, growing and evolving environment  
• Demonstrated strong work ethic, with a track record of following through on client requests and with high-quality deliverables on schedule and on budget  
• Able to work independently and as part of a team 
• Competent in using Microsoft Word, PowerPoint, Excel, and Outlook 
• Experienced in developing client relationships and networking 
• Strong financial acumen 
• Comprehension of project and account objectives, contributing to strategic planning 
• Able to devise and articulate solutions to problems on an ongoing basis  
• Able to clearly communicate project updates, scopes and recommendations to clients  
• Veeva management and/or iEnvision experience recommended but not required  
• BA or equivalent work experience required  

Pay Range: $70,000.00-$100,000.00

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.  

Position Overview 

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

Essential Duties

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

Necessary Skills and Abilities:

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

Educational Requirements:

• MD or DO

Experience Requirements:

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

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

Position Summary

Primary Responsibilities

• Develop materials to support GAP internal communications and external advocacy programs.  These may include internal newsletters, intranet content, program updates, talking points, slide decks; and external advocacy materials such as draft letters, emails, infographics and other collateral for use in advocacy programs
• At the direction of the Director of State Government Affairs, build strong and productive relationships with relevant state and local elected officials, community-based organizations, and civic partners to elevate Acadia’s visibility and drive successful outcomes for policy priorities
• Monitor state legislative and regulatory developments and provide timely analysis and updates to internal stakeholders
• Represent Acadia in relevant state and local trade associations and coalitions (e.g., BIOCOM, California Life Sciences Association, BioNJ)
• Partner with internal functions to develop briefing materials, policy positions, and presentations tailored to state and federal stakeholders
• Support the entire GAP team and work closely with our internal partners on the AIR, Commercial, Communications, Medical, R&D, Regulatory teams and others as directed
• Other duties as assigned.

Education/Experience/Skills

• Bachelor’s or Master’s degree in a relevant field such as health care administration or public policy, or equivalent relevant experience, with 5+ years of experience in health care policy and a strong understanding of today’s complex health care policy landscape.
• Proven ability to communicate effectively in both verbal and written formats
• Experience anticipating public policy trends in the health care sector
• Strong understanding of the current political environment and of policy-making processes at the state and federal level, including both legislative and regulatory processes
• Experience working across multiple functions within an organization to advance team- and enterprise-level goals
• Demonstrated ability to work collaborative and achieve consensus across a matrix environment
• Capable of managing multiple projects simultaneously with precise attention to detail, quality, and timelines.

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-CS1

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

Job Title: General Affairs Manager

Location: Piscataway, NJ (Fully Onsite)

Reports To: Director of US Site Operations

Compensation: The estimated salary range is $100,000 - $115,000, based on experience level.

Job Scope:

The General Affairs Manager is responsible for site operational coordination, stakeholder engagement, and administrative strategic vendor management. This role oversees the administrative function through an Admin Supervisor while leading cross-functional initiatives and operational excellence programs at the Piscataway sites.

Key Responsibilities:

1. Stakeholder Management & Corporate Hospitality

• VIP Visit Coordination: Lead the planning and execution of visits for government delegations, key account clients, and global executive tours.
• Define and maintain site reception standards to ensure a professional corporate environment.
• Corporate Events: Oversee high-impact site events and cultural programs that align with company values.

2. Strategic Vendor & Contract Management

• Commercial Negotiations: Directly lead negotiations with key service providers (e.g., hotel groups, airlines, and catering partners) to secure preferential rates and enhanced employee benefits.
• Service Excellence: Establish KPIs for all major vendors and conduct regular performance reviews to ensure service quality and cost-efficiency.

3. Site Operations & Lean Promotion

• Operational Excellence: Partner with the Site Director to implement Lean, 5S, and continuous improvement (CI) initiatives within the administrative and public areas of the campus.
• Cross-Functional Coordination: Act as the operational bridge between General Affairs, Facilities, EHS, and other departments for site-level projects, such as space enhancements or workflow optimizations.

4. Team Leadership & Governance

• Team Direction: Direct the Sr. Admin Supervisor and team to ensure the high-quality delivery of daily administrative services (travel, catering, office supplies).
• Process Standardization: Lead the development and optimization of Standard Operating Procedures (SOPs) for all GA functions to ensure operational consistency and scalability.
• Financial Management: Own the departmental budget, tracking spending and implementing cost-saving measures through data-driven analysis.

Core Requirements:

• Professional Experience: 4+ years in corporate administration, operations management, or project management.
• Negotiation Skills: Proven ability to manage vendor relationships and lead commercial contract negotiations with measurable outcomes.
• Communication: Excellent interpersonal skills; must be able to influence and coordinate across all levels of a global organization.
• Education: Bachelor’s degree in Business, Operations, or a related field.

Preferred Skills:

• Lean Mindset: Interest or experience in applying Lean, 5S, or other continuous improvement methodologies to administrative operations.
• Project Management: Demonstrated ability to manage multiple projects simultaneously with strong attention to detail.

#GS

#LI-EB1

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

Position Summary 

Acadia Pharmaceuticals is seeking a seasoned and strategic Health Economics and Outcomes Research (HEOR) leader to serve as Senior Director, HEOR. In this critical role, you will lead the development and execution of comprehensive value evidence strategies that demonstrate the clinical, economic, and humanistic value of Acadia’s therapies across their lifecycle, from development through commercialization and global market access.

As the demand for high quality real world evidence and outcomes research continues to grow, this role will be central to supporting health technology assessments, payer decision making, reimbursement, and product differentiation. You will oversee the generation and dissemination of HEOR evidence, including real world evidence, economic modeling, and clinical outcomes assessments, to support access and adoption across global markets.

The Senior Director, HEOR will be responsible for shaping and communicating the value story for assigned products or indications, leading the development of global value dossiers, economic models, and HTA strategies that clearly articulate the benefit of Acadia’s therapies to patients, healthcare systems, and population health decision makers. This role requires close collaboration with Commercial, Market Access, Clinical Development, Medical Affairs, Regulatory, and other cross functional partners to ensure HEOR strategies are aligned with scientific objectives, business priorities, and regulatory expectations.

The ideal candidate brings deep expertise in outcomes research methodologies, strong scientific and strategic judgment, and the ability to lead complex, cross functional initiatives in a fast paced, global environment. This position offers a unique opportunity to shape evidence strategies that influence access, reimbursement, and ultimately patient outcomes for therapies addressing significant unmet medical needs.

Primary Responsibilities

• Build and implement the strategy for HEOR, including RWE and HTA evidence generation & dissemination within an assigned area for in-line and pipeline assets.
• Lead delivery of value evidence generation strategies throughout the product life cycle.
• Oversee and guide the development and implementation of patient-reported outcomes (PRO) and COA endpoints strategy.
• Ensure the work delivered by HEOR in the assigned area aligns with R&D and corporate goals.
• Represent HEOR on various cross-functional teams in commercial/clinical/medical areas.
• Direct and implement relevant HEOR initiatives with external entities.
• Contribute to the development and execution of overall and HEOR-specific publication plans.
• Establish an integrated HEOR plan aligned with Commercial, Market Access, and Scientific objectives.
• Other duties as assigned.

Education/Experience/Skills

• Master’s degree in public health, economics, epidemiology, health services research or HEOR-related field. 
• Targeting 12 years’ experience in the pharmaceutical or medical device industry; or, a Doctorate in health services research, pharmacy, medicine, public health, economics, and targeting 9 years’ experience in global biopharmaceutical or medical device industry. 
• Experience in outcomes research methodologies (retrospective observational cohort, cross-sectional studies, registries, etc.) to support product development and reimbursement efforts is required. 
•  Must have experience with the execution of scientifically robust qualitative and quantitative studies, development and validation of COA measures, including assisting clinical development teams in implementing COAs in clinical trials to measure patient-relevant endpoints.

Key Skills:

• Understanding of the global healthcare environment, clinical research processes, global regulations, and ethical guidelines.
• Rare disease or CNS experience with interactions with US and ex-US reimbursement agencies is preferred.
• Highly developed communications skills (written/verbal) and interpersonal savvy.
• Proven meeting planning and team facilitation skills.
• Ability to create, track, plan, and communicate project timelines to team members, and maintain budgets.
• Ability to create, track and plan timelines and budgets.
• Ability to support multiple projects while being well-organized, have strong time management skills, and attention to detail.
• Excellent organization and multi-tasking skills.
• Ability to accommodate shifting priorities, demands and timelines.
• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.
• Knowledge of regulatory guidance documents and scientific guidelines (FDA guidance; FDA qualification documentation; dossier outline; EMA guidance resources; ISPOR Task Force Documents, etc.).
• Understanding of instrument development and validation process.
• Strong computer skills (Microsoft Office, etc.) and knowledge of database management (Veeva Vault, etc.).
• Must be able and willing to travel (up to approximately 40%) for conferences, meetings, and HEOR project or team-management related business.

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-SW1

#LI-Hybrid

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

Job Title: Construction Project Manager

Location: Piscataway, NJ (Fully onsite)

Reports to: Director of US Site Operations

Compensation: The estimated salary range is $120,000 - $150,000, based on experience. 

Overview: 

GenScript is seeking a talented, detail oriented and self-driven individual to join the Operations Department, contributing to the planning, design, construction, commissioning, validation, and engineering process systems development for our facilities in Piscataway, NJ. This position is valid for at least 1-2 years with the opportunity to transition to facility manager after the construction projects are done.

Job Responsibilities: 

Project Planning and Execution: 

• Develop comprehensive project plans ensuring projects proceed according to set objectives, including requirement gathering, feasibility analysis, risk assessment, and solution formulation.
• Manage cost estimation for all project phases and create cost control plans.
• Procurement and Contract Management.
• Oversee bidding and procurement for project design, construction, and long-lead equipment.
• Manage contract signing and execution with suppliers and contractors, ensuring compliance with terms, quality, and deadlines.

Compliance and Regulatory Affairs: 

• Plan and execute government and third-party procedures to ensure project compliance with US regulations.
• Plan and manage government permits applications.

Project Management: 

• Manage technical, quality, safety, and timeline aspects of projects, ensuring timely resolution of technical issues, compliance with quality standards, and implementation of safety measures.
• Coordinate with construction firms, supervisory, and contracting units to manage internal and external project relationships.
• Commissioning and Validation:
• Organize factory acceptance tests, commissioning, and validation to ensure systems meet user requirements.

Project Completion: 

• Lead the final inspection, handover, documentation review, and project settlement activities, ensuring successful project completion and handover.
• Reporting and Improvement:
• Regularly report project progress, compile project reports, analyze lessons learned, and suggest improvements.

Qualifications and Requirements

Education and Experience: 

• Bachelor's degree or higher in Mechanical/Electrical, Chemical Engineering, Biomedical Engineering, or related fields.
• 10+ years of experience in biopharmaceuticals with substantial project management and facility operations experience.
• Hands on experience in managing construction, experience in executing projects from business requirement collection through to design, construction, commissioning, validation, and final settlement is preferred.

Skills: 

• Strong management and reporting capabilities, clear management vision, able to handle high-pressure work environments.
• Solid technical expertise combined with engineering knowledge.
• Demonstrated skills in problem solving, root cause analysis with result driven thought process.

Additional Considerations: 

• Proficient in project management software (e.g., Procore, Microsoft Project, Primavera P6).
• Familiarity with construction estimating and scheduling tools.
• Understanding of US building codes, zoning laws, safety regulations, and biopharmaceutical industry standards.

#LI-EB1

#GS

Position

As a Senior Medical Writer 2, you will play a pivotal role in translating complex scientific and medical information into clear and concise written materials. Operating in a dynamic and collaborative environment, you will contribute to the development of various documents that support our research, clinical trials, and regulatory activities.

About You 

The ideal candidate for this position should possess strong writing and communication skills, with the ability to effectively convey complex scientific concepts in a clear and concise manner. Exceptional attention to detail and a commitment to producing accurate and high-quality written materials are essential. Proficiency in Microsoft Office Suite and familiarity with scientific writing tools is important, and the candidate should be capable of thriving in a fast-paced and collaborative work environment. While knowledge of clinical research, regulatory requirements, and biotechnology is advantageous, it is not required.

What You’ll Do

• Document Preparation: Create a wide range of medical and scientific documents, including clinical study protocols, investigator brochures, regulatory submissions, and scientific publications.
• Content Development: Collaborate closely with cross-functional teams to collect and interpret data, ensuring accuracy and relevance in written materials.
• Regulatory Compliance: Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards.
• Literature Review: Conduct comprehensive literature reviews to support the development of evidence-based documents.
• Data Interpretation: Proficiently interpret and summarize complex scientific data and clinical trial results for various audiences.
• Editing and Proofreading: Review and edit documents for grammar, clarity, and consistency while maintaining a high level of accuracy.
• Collaboration: Collaborate closely with scientists, clinical teams, and regulatory affairs professionals to align written materials with project goals and timelines.
• Mentorship: Provide guidance and mentorship to junior medical writers, fostering their professional growth and development.

Qualifications

• PhD with 3 years of experience or a Master’s degree with 6 years of experience or a Bachelor's degree with 8 years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline). 
• Strong writing and communication skills, with the ability to effectively convey complex scientific concepts in a clear and concise manner.
• Must have hands on experience with independently drafting CSRs, ICFs, IBs, Protocols, and/or CTD modules
• Exceptional attention to detail and commitment to producing accurate and high-quality written materials.
• Proficiency in Microsoft Office Suite and familiarity with scientific writing tools.
• Capability to thrive in a fast-paced and collaborative work environment.
• Knowledge of clinical research, regulatory requirements, and biotechnology is advantageous but not required.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $148,000 to $161,500 depending on skills, competency, and the market demand for your expertise.

Job Summary:

Real Chemistry is looking for a Managing Director to join our growing team!

The Managing Director will be a senior leader tasked to drive the agency strategy, positioning, and offerings for our clients.  They will support a distinctive employee experience for our multi-disciplinary and multi-cultural team.

The majority of clients come from the healthcare sector with aspirations to expand into non-healthcare markets over time while continuing growth in healthcare. The current scopes are diverse and include multiple fields: PR, CTR, digital and social marketing, internal communications, branding, analytics and tech dev. Our clients know us as an integrated consultancy to whom they can trust – regardless of project scope or scale.

Our Managing Directors are agile, responsive, and have strong conceptual thinking capabilities. As Real Chemistry has continuously achieved significant growth over the past several years, this person should also be comfortable with ambiguity and the uncertainty which comes with rapid innovation and growth. We are a senior-led team and our clients expect to have access and regular counsel from our leadership. This person will also need to be comfortable being tactically involved in the day-to-day workings of client work.

In addition, there is a need for strong internal communications to help lead change within the organization, support controlled growth, and maintain strong retention rates.

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do:

• Position yourself as an industry leader, networking to develop brand awareness.
• Build on current Medical Communication and Marketing offering to establish an operationalized, multi-disciplinary team including analytics, digital and creative.

• Previous experience of working in an agency environment in a similar position
• Proven track record of growing complex and multi discipline and integrated clients
• Proven success in new business and business development
• An entrepreneurial and innovative approach to growing clients and revenue for the business
• Must demonstrate strong commercial and financial acumen; having led a profitable business or business vertical

• Develop programs targeted specifically at Medical Affairs and Clinical Trials teams to access a new target audience for our consultancy.
• Grow the opportunities with clients into a broader portfolio of offerings including digital media, marketing, advertising, and social media.
• Lead all aspects of current portfolio and growth through current client base, net new business, and manage to profitability.
• Provide counsel across several existing accounts and lead multi-disciplinary team to deliver against client critical metrics.
• Client lead on a number of accounts providing senior strategic counsel, building multi- disciplinary teams by working in collaboration with shared services (analytics and creative) teams, as well as SMEs.
• Immerse quickly in Real Chemistry offerings and methodologies to take a coordinated approach to clients and new business.
• Develop 30-60-90 day plan to outline key needs and contributions; set expectations internally.
• Partner with current leadership team to drive and deliver a robust strategy for the consultancy.
• Facilitate training and mentoring of team to support the growth of the business. Infuse team with energy and passion through internal communication and respected partnership.
• Identify new hires to accelerate business growth through broader network or new skill set.

This position is a perfect fit for you if:

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Alwaysand Accountability with an “I” – really speak to you.
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.
• You are highly organized self-starter, able to work independently and under tight deadlines.

What you should have:

• Bachelor’s degree or equivalent experience is required.
• 15+ years in a professional environment within the public relations, communications, or advertising industry.
• Management experience required; an approach to staff management that brings out the best in team members yielding operational excellence, pride, ownership, and a deep dedication to Real Chemistry.
• A successful track record of winning new business and growing current business.
• Outstanding communication skills to connect with a variety of audiences.
• The experience, ability and inclination to be an effective, inspiring leader for Real Chemistry.
• Exemplary interpersonal and listening skills; cultural sensitivity, particularly with respect to collaborating with global audiences via multiple media.
• Exceptional client management skills.
• A keen eye for operational efficiency and optimal use of resources; an aptitude for use of data and metrics in decision-making; the ability to plan, monitor, and tightly manage a budget.
• An awareness, appreciation, and knowledge of analytics and multi-channel marketing.
• A genuine passion for contributing to the transformation of a consultancy that is operating in a constantly evolving environment and a desire to work with a high-energy leadership team who sets the highest standards of performance.
• Strong team-based orientation; a personality that thrives in matrixed environments and enjoys partnering with all levels of team members to achieve results.

Pay Range: $200,000-$230,000
This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.  

RC Resolve is a strategic communications advisory firm working at the intersection of finance, corporate reputation, public affairs, and brand for healthcare companies, backed by the capabilities and expertise of Real Chemistry.  

We partner with boards and management teams during normal course and transformative periods to design communications strategies that help companies advance business goals, build trust, and seize timely market opportunities. We counsel executives and boards through highstakes moments including M&A, IPOs, restructurings, shareholder activism, crises, and major corporate transformations. 

We are seeking a senior leader to build and lead our Financial and Transaction Communications offering, working with clients across sectors and geographies. 

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

Role Overview 

The Head of Financial and Transaction Communications will be a senior leader responsible for: 

• Building and leading our financial communications practice 

• Serving as a primary advisor to CEOs, CFOs, General Counsel, Heads of IR, and Boards working in concert with their key advisors 

• Driving new business and deepening relationships with existing clients to support issues and opportunities  

• Leading teams through complex, high-stakes, timesensitive, and confidential situations 

This role suits an experienced financial communications professional from a top-tier advisory firm, inhouse IR/corporate comms team, or similar environment, who thrives in fastpaced, transaction driven work and business- and relationship-building opportunities. 

Key Responsibilities 

Client Advisory & Strategy 

• Serve as trusted counselor to senior executives on all aspects of financial and capital markets communications. 

• Develop and oversee integrated communications strategies around:

• IR Advisory
• M&A
• IPOs and SPACs
• Activist Defense & Preparedness
• Restructuring
• Bankruptcy
• Executive Transitions
• Divestitures & Spins
• Investor and R&D Days
• Financial Media Relations & Storytelling

• Craft clear, compelling narratives that translate complex financial and strategic issues for investors, media, employees, regulators, and other stakeholders. 

• Provide real-time strategic counsel in high pressure, confidential situations, often in partnership with legal and banking advisors. 

Transaction/Event-driven Communications 

• Lead communications workstreams for event-driven situations (to include but not limited to: M&A, IPOs/Spins/SPACs, activism, bankruptcies/restructurings, crisis (cyber, litigation and beyond), Board/management transitions.), including: 

• Prospecting, relationship building with key advisors (bankers, lawyers, etc.) focused on HC sector. 

• Leading transaction / event-driven work. 

• Development of comms strategy, materials, media and social considerations. Support of the lead up to announcement, announcement day as well as integration support. 

• Deal playbook and scenario planning to protect and preserve reputation and valuation throughout the deal process 

• Development of strategy, scenario planning, communications playbook, etc. for lead up to, day of and post-announcement situation  

• Drafting key materials (press releases, Q&As, investor decks, fact sheets, talking points, etc.) 

• Coordinating with key advisors (lawyers, bankers, etc.) and ensure alignment with regulatory and disclosure requirements 

IR Advisory & Related Services 

• Develop and refine clients’ equity story/investor narrative 

• Oversee creation and quality of investor facing collateral, including: 

• Investor presentations 

• Investor day/R&D day materials  

• Infographics 

• IR website alignment with collateral 

• Earnings Advisory: Advise and support the development of earnings materials: to include press release, deck, scripts, Q&A prep  

• Advise on engagement with sellside and buyside analysts in coordination with IR and legal teams. 

• Annual reports as well as sustainability reports (in partnership with design/ESG teams as needed). 

• Advise on integration of financial communications with broader corporate reputation, ESG, and public affairs strategies. 

Financial Media & Stakeholder Engagement 

• Lead financial and business media strategy, cultivating relationships with key journalists and outlets. 

• Prepare executives for highstakes media interviews, investor meetings, earnings calls, and roadshows. 

Practice & People Leadership 

• Build and lead a high-performing financial communications team within the agency, including integration of legacy IR team, recruitment, training, and mentorship. 

• Set practice standards, playbooks, and bestinclass approaches for transaction and capital markets mandates. 

• Foster collaboration across practices (corporate, crisis, public affairs, digital, ESG, brand) to deliver integrated solutions. 

• Contribute to firm leadership, culture, and DEI objectives. 

Business Development 

• Drive growth of the financial communications practice through: 

• Identifying and pursuing new business opportunities 

• Leading and contributing to pitch development and presentations across significant client base 

• Build rapport and become a trusted, go-to referral partner for network among corporates, private equity, banks, law firms, and other advisors. 

• Help shape the agency’s market profile via thought leadership (reports, opeds, conferences, webinars) on capital markets, M&A, activism, and related themes. 

Qualifications 

• 15+ years of experience in financial communications, investor relations, investment banking, equity research, or related fields, with a strong advisory component. 

• Proven track record working on complex, highstakes situations such as: 

• M&A (including crossborder, contested, and private equitybacked deals) 
• IPOs and significant capital markets transactions 
• Shareholder activism and governance/ESG-related campaigns 
• Restructurings, turnarounds, and crisis situations with market impact. 
• Experience in a leading strategic communications/PR firm (e.g., financial/transaction communications practice) or top-tier in-house corporate role strongly preferred.  

• Experience working with healthcare clients a plus      

Skills & Capabilities 

• Deep understanding of capital markets and the needs of institutional investors and analysts. 

• Exceptional writing skills: capable of producing clear, concise, and persuasive materials under tight deadlines. 

• Strong judgment and discretion, with demonstrated ability to advise senior executives and boards in sensitive situations. 

• Comfortable operating in fast-paced, ambiguous, and time pressured environments; calm and solutions-oriented under stress. 

• Strong project and team management skills; able to run multiple complex engagements simultaneously. 

• Collaborative and low ego; able to integrate with cross-functional teams including legal, banking, IR, public affairs, digital, and creative. 

Education & Other 

• Bachelor’s degree required; advanced degree (MBA, JD, or related) a plus but not required. 

• Understanding of US regulatory and disclosure frameworks; global regulatory expertise not required but helpful 

• Willingness to work extended hours during live situations and to travel as required. 

  Pay Range: $300,000 - $360,000

  This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time

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 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

About us:

Forge Health is a mission-driven outpatient mental health and substance use provider dedicated to providing the highest quality, affordable, and effective care to individuals, families, and communities in need. As the first and only behavioral healthcare provider with a proven, national payer-validated ability to drive clinical outcomes that span all areas of health, Forge Health is leading the charge in driving innovation, improving care delivery, and shaping the future of behavioral health care.

At Forge, clinical care is paramount – it’s the heartbeat of our operations and the driving force in everything we do. The skill and compassion of our staff are the crucial components to extraordinary experiences and outcomes for those we serve. With our current clinical footprint in the greater Northeast, we have offices in New York, New Jersey, Pennsylvania, New Hampshire – and we’re growing! Come join us!

Who we’re looking for:

The Regional VFR Peer Engagement & Growth Specialist is a field-based role for the state of New Jersey responsible for expanding access to behavioral health and substance use services for Veterans, First Responders, and their families.

This position drives referrals into Intensive Outpatient (IOP), Outpatient (OP), and psychiatric services by developing and activating referral relationships across Veteran and public safety systems. The role also supports the development and coordination of peer-based programming within the assigned region.

This is not a traditional sales role. Success requires the ability to build trust within Veteran and First Responder communities, understand clinical pathways, and translate community relationships into consistent patient access and program utilization.

This role operates with a high degree of autonomy and is responsible for managing and growing a defined geographic territory.

Compensation range: $60-100k, this salary range reflects total compensation, which includes base compensation and bonus payouts, however it is not inclusive of benefits and other company perks. Exact compensation may vary based on skills, experience, and location.

What you’ll be doing:

Referral Development and Market Growth

• Drive consistent referral volume into IOP, OP, and psychiatric services within the assigned territory
• Develop, activate, and maintain referral pipelines specific to Veteran and First Responder populations
• Execute territory-based outreach strategies aligned with regional growth targets
• Improve referral-to-intake conversion through targeted partner education and follow-through
• Identify and prioritize high-value referral sources and underserved access points

Strategic Partnership Development

• Establish and maintain relationships with:
• Veterans Affairs (VA) and Community Care Network (CCN) providers
• Veteran Service Organizations (VSOs)
• Police, Fire, and EMS departments and leadership
• Peer support teams and Critical Incident Stress Management (CISM) programs
• Hospitals, primary care providers, detox programs, and behavioral health organizations
• State and county agencies serving Veterans and public safety personnel
• Serve as a trusted resource on:
• Behavioral health service access
• Level-of-care placement (IOP, OP, psychiatric services)
• Navigation of care systems and referral pathways

Community Engagement and Market Presence

• Represent the organization within Veteran and First Responder communities
• Participate in coalitions, regional initiatives, and public safety engagements
• Plan and facilitate educational sessions, site visits, and outreach events
• Maintain consistent visibility and credibility within assigned markets

Peer Programming Development and Support

• Support the development and coordination of peer-based programming in collaboration with clinical and operational leadership
• Identify opportunities for embedded services, department-based programming, and wellness initiatives
• Align peer programming efforts with clinical care pathways and regional needs

Internal Collaboration and Market Intelligence

• Collaborate with Clinical, Intake, Operations, and Marketing teams to improve access to care and remove referral barriers
• Maintain accurate CRM documentation of outreach activity, referral pipelines, and partner engagement
• Provide ongoing feedback regarding market conditions, referral trends, and growth opportunities
• Support regional expansion initiatives and service line development

How you’ll be successful:

• Achieve defined monthly referral targets across Veteran, First Responder, and general behavioral health sources
• Maintain target referral-to-intake conversion rates
• Develop and sustain an active, engaged pipeline of referral partners (not passive relationships)
• Demonstrate measurable growth in IOP and OP utilization within the assigned territory
• Maintain consistent CRM documentation and pipeline visibility

What you'll need:

• 3–5+ years of experience in behavioral health, healthcare outreach, provider relations, or business development preferred
• Experience working with or supporting Veterans, First Responders, or public safety systems strongly preferred
• Knowledge of behavioral health services, including substance use and co-occurring conditions
• Ability to establish credibility with Veteran and First Responder communities, including public safety leadership and peer support teams
• Demonstrated ability to engage effectively with both clinical providers and organizational leadership (e.g., chiefs, command staff, administrators)
• Strong communication, relationship-building, and organizational skills
• Experience with CRM systems or outreach tracking tools preferred
• Experience working within or alongside public safety agencies, healthcare systems, or community-based behavioral health programs preferred
• Ability to work independently and manage a defined geographic territory
• Valid driver’s license and reliable transportation

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