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

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

Position Summary:

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

Primary Responsibilities:

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

Education & Experience:

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

Required Skills:

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

Physical Requirements:

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

#LI-SM1 #LI-HYBRID

Please note that this position 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

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 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