Otsuka Pharmaceutical Co., Ltd.

Role Description Otsuka America Pharmaceutical Inc. is a global healthcare company with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. The Neuroscience Specialist engages healthcare providers (HCPs) using in-person, virtual, and digital tools, offering expertise on products and their approved conditions. This position is designed to enhance customer engagement, thought leadership, and business planning within the organization. The role involves proactive outreach to healthcare professionals (HCPs), facilitating discussions, and elevating insights to inform strategic decisions. Below is a detailed overview of the key responsibilities and objectives associated with this position: - Personally engage customers through various virtual or digital tools. - Direct customers to other colleagues, such as Customer Service Specialists (CSS), as needed. - Ensure customer requests are met and solicit feedback on the quality of engagement. - Facilitate speaker programs to share knowledge and insights. - Organize local provider groups for discussions on experiences and outcomes with local/regional leaders. - Elevate opportunities and feedback to the Area Business Lead, including local market insights. - Collaborate compliantly with the ecosystem team to adjust targeting and call point plans. - Action on insights collected from customer-facing roles to inform local strategy and business goals. Qualifications - A minimum of 2 years of pharmaceutical or medical device sales experience. - Prior experience in CNS, psychiatry, or ADHD preferred. - Experience launching a new product or new indication preferred. - Must reside within a commutable distance of 50 miles from the primary city in the sales territory. - Previous cross-functional industry experience in commercial life sciences or related industry. - 4 or more years of experience working in a sales role with HCPs, ideally representing multiple products. - Ability to work in an ambiguous environment undergoing transformation. - Proven track record in coaching, training, and mentoring peers or others. - Demonstrates a commitment to ethical business practices, an understanding of regulatory standards, and the ability to execute business activities in compliance with Company policies and guidance. - Ability to assimilate and communicate complex clinical and product information. - Valid U.S. driver’s license and acceptable driving record. - Overnight travel may be required depending on territory geography. Requirements - Conduct proactive outreach to HCPs on topics such as product access, on-label information, and established patient care guidance. - Engage customers through various virtual or digital tools and direct them to other colleagues (e.g., CSS) as needed. - Facilitate speaker programs and organize local provider groups for discussions on experiences and outcomes with local/regional leaders. - Elevate opportunities and feedback to the Area Business Lead, including local market insights to inform local strategy and business goals. Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits.

Role Description The Rexulti Product Training Manager will be responsible for developing and executing training programs that support both the ReadyNow Training for sales (60% effort) and Rexulti product training needs (40% effort). This role will serve as a key liaison between ReadyNow Leadership, Field Training & Development, Sales, and other cross-functional teams to ensure alignment with organizational goals and strategies. The position requires a proactive approach to training, with a focus on enhancing field effectiveness and ensuring comprehensive product knowledge. - Collaborate with ReadyNow and Field Leadership to identify training needs and implement effective training strategies for sales teams. - Develop and deliver Rexulti product training programs, ensuring alignment with brand objectives and sales strategies. - Support the execution of field readiness training content and initiatives, working closely with field leadership. - Facilitate monthly training sessions, including agenda preparation, guest speaker coordination, and follow-up action plans. - Conduct field visits to gather insights and provide feedback on training effectiveness and developmental needs. - Assist in planning and organizing training events such as New Hire Product Training and Train the Trainer sessions. - Work with external vendors to develop and evaluate training materials, ensuring quality and compliance with company standards. - Provide strategic recommendations to ReadyNow Leadership based on field observations and feedback. - Travel up to 40-50% to support training initiatives. Qualifications - Required: BS/BA Degree - 5+ years of pharmaceutical sales experience or teaching/training experience - Experience in CNS Sales - Strong leadership and collaboration skills - Excellent communication and presentation skills - Proficiency with Microsoft Office software - Project management skills - Knowledge of pharmaceutical, medical, and managed care environments - Preferred: CNS sales experience - Field Sales Trainer or other training experience Requirements - Management Level: Manager Benefits - Comprehensive medical, dental, vision, prescription drug coverage - Company provided basic life, accidental death & dismemberment - Short-term and long-term disability insurance - Tuition reimbursement - Student loan assistance - A generous 401(k) match - Flexible time off - Paid holidays and paid leave programs - Other company provided benefits

Role Description This position will be responsible for representing OAPI with Regional Payers. This includes interacting with all assigned payer channels and customers to attain and maintain profitable access for OAPI brands. This position is responsible for representing the entire Otsuka portfolio of products in the prioritized accounts (typically 15-20 accounts) within their assigned geography. Strong preference to reside in geographic area of responsibility. The position will report to Director, Market Access Regional Accounts. - Ability to articulate compelling unbranded and branded messaging within PI labeling including the Brand Value Propositions, Brand clinical information (approved reprints) and approved Health Economic Data and Models. - Further customer engagement by providing insights/expertise in relevant Therapeutic Areas and customer insights on trends, market conditions, and changes in formulary/medical policies. - Leverage and Champion core market access resources and sales planning tools. - Ensure thorough completion and submission of the Contract Request Form in a timely manner to Finance (P&C). - Enable MML/HEOR/Marketing team interactions with Customers to include Collaborate and consult with stakeholders across the matrixed organization to develop patient-centric solutions unique MML engagements and relationship building with peers. - Support the National Account team to develop and communicate clear and effective pull-through initiatives that will drive successful contract performance through collaboration with the Customer Engagement Team in alignment with the Senior Business Director. - This position is responsible for coordinating the regional pull/push through initiatives for their assigned geography. Each RAM geography represents between 5-15% of the total net product sales across the Otsuka portfolio. - Collaborate and consult with functional matrix team leaders to optimize business performance and/or manage complex business risks and issues. - Engage with Otsuka Government Affairs and Advocacy to ensure execution against opportunities and threats in area of responsibility. - Develop and execute Regional Matrix Business Plans in cooperation with cross-functional leaders (Customer Engagement Team, Medical Affairs, Marketing, Market Access & Patient Support). - Develop Regional Market Access strategy that leads to broader and deeper relationships within priority accounts. - Review and correct Formulary information monthly via MMIT data. - Conduct all activities in compliance with all applicable local, state and federal laws and regulations as well as company policies. - Responsible for the market shaping for disease state interest and future launch products at the prioritized accounts within their geography. Qualifications - Bachelor’s degree. - 3+ years of demonstrated success in account management or B2B experience. - Exceptional track record in business to business negotiations. - Proven track record of consistently meeting or exceeding quantitative and qualitative targets. - Ability to work effectively within cross-functional teams and in an environment of rapid change. - Excellent written, organizational and verbal communication skills a must. - Proficient in MS Office products including PowerPoint, Word, Access and Excel. Requirements - MBA degree (preferred). - Experience in a leadership or people management role (preferred). Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits.

Role Description Otsuka is seeking a dynamic, strategic, and experienced individual to serve as the Associate Director of Global Supplier Performance & Metrics. The role is responsible for leading execution of supplier quality management strategies that ensure the quality, compliance, performance, and reliability of external suppliers supporting Otsuka's global development and commercial operations. This role serves a key quality role assisting with supplier management activities and overseeing supplier performance oversight activities. This position partners closely with Global Quality, Technical Operations, Supply Chain, Regulatory Affairs, and external suppliers to establish and maintain a robust supplier quality framework aligned with global GMP, GDP, and applicable regulatory requirements. This leader is responsible for managing critical supplier relationships, driving continuous improvement initiatives, developing supplier quality metrics, and providing management-level insights regarding supplier quality performance, risks, and mitigation strategies. Key Responsibilities - Strategic Supplier Oversight & Relationship Management - Critical Relationship Governance: Serve as the primary Global Quality lead for Otsuka’s tier-one and identified critical external suppliers, contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs). - Quality Business Reviews: Partner with Global Procurement and Supply Chain to assist with regular Joint Steering Committees and Business Review Meetings, injecting a firm, data-driven quality scope into these meetings. - Relationship Building: Foster a culture of collaborative accountability with suppliers, implementing a strategic partnership that proactively prevents quality issues or failures. - Data Analytics, KPIs, & Executive Readouts - Metric Architecture: Contribute to the development, implementation, and tracking of standardized Global Supplier Quality metrics, dashboards, and KPIs. - Management Readouts: Synthesize complex data sets into concise, high-level quality performance presentations and provide supplier quality performance updates and insights to management. - Predictive Risk Modeling: Use quality metrics to identify negative trends in supplier performance, initiating preemptive mitigation strategies. - Supplier Management & Auditing - Audit Lifecycle Management: Oversee the execution of the global supplier audit schedule, ensuring robust evaluation of active pharmaceutical ingredient (API) manufacturers, drug product CMOs, packaging suppliers, and critical laboratories. - Quality Agreements: Assist with the negotiation, drafting, and maintenance of comprehensive global Quality Agreements. - System Ownership: Champion the optimization and daily utilization of TrackWise Digital for all supplier quality modules. Qualifications - Education: Bachelor’s degree in a scientific, engineering, or health-related discipline (e.g., Chemistry, Biology, Pharmacy) is required. An advanced degree (MS, MBA) is preferred. - Industry Experience: A minimum of 8 years of progressive experience within the pharmaceutical, biopharmaceutical, or medical device industry, specifically focused on quality assurance, supplier quality, or CMO management required. - Leadership Experience: Minimum of 5 years of direct managerial experience managing, developing, and evaluating quality professionals in a global or matrixed environment. - Technical & Software Skills: - Hands-on experience with TrackWise Digital is strictly required. - Knowledge of global GxP regulations (FDA 21 CFR 210/211/11, EU GMP, EudraLex Volume 4, ICH guidelines Q7, Q9, Q10). - Certification or proven track record exhibiting lead auditor capabilities. - Soft Skills & Core Competencies: - Advanced analytical capabilities. - Exceptional communication skills. - Demonstrated ability to handle difficult conversations with critical external suppliers. Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits. Application Deadline This will be posted for a minimum of 5 business days.

Role Description The Associate Director of Global Contact Center Services is responsible for providing strategic oversight for all contact centers across regions Globally and for direct management of the U.S. Contact Center. - Collaborates effectively with all regions to achieve contact center organizational objectives aligned with corporate strategy and goals. - Provides strategic vision, leadership, and direction to regional contact center teams, ensuring documentation and processing alignment where possible. - Maintains current resource information for U.S. Contact Center use by ensuring the development of new, or update of existing resource information such as triaging guidance, email templates, FAQs, and new or updated product materials. - Provides training and instructional materials, guidance, and support to U.S. Contact Center Project Managers, team members, and internal stakeholders as needed. - Provides strategic direction to the U.S. Contact Center to ensure capturing of appropriate metrics and key performance indicators (KPIs) for continuous improvement of contact center activities. - Serves as a business partner with various stakeholders including Quality, Pharmacovigilance, Medical Affairs, Commercial, Legal, Regulatory, and Compliance. - Supervises U.S. Otsuka personnel as applicable (in-house and contracted) on the daily provision of U.S. Contact Center activities. - Develops, enhances, and/or implements policies, procedures, and processes for the U.S. Contact Center. - Contributes to and leads interdepartmental projects as needed. - Maintains a high level of knowledge pertaining to Otsuka products. - Contributes to budget discussions for the U.S. Contact Center. - Provides direction & support to the U.S. Contact Center vendor on all administrative contact center functions. - Ensures vendor system access to the Otsuka electronic learning management systems (eLMS) training materials. - Acts as the Otsuka point of contact for internal and external stakeholders on case escalation and/or coordination of all U.S. Contact Center projects. - Works directly with vendor to ensure U.S. Contact Center service level agreements (SLA’s) are met. - Provides U.S. Contact Center project status reports to leadership on a regular basis. - Ensures quality review of U.S. Contact Center case documentation and recorded calls as needed. - Manages all U.S. Contact Center vendor/internal stakeholder meetings to ensure transparency and resolution of reported issues. - Provides assistance and/or training to other U.S. Contact Center personnel and stakeholders as needed. - Attends team meetings and external contact center conferences to represent Otsuka as appropriate. - Recognizes/identifies and ensures appropriate forwarding of product quality and/or safety/adverse event information according to FDA guidelines. - Handles the receipt, documentation, and response to written medical information requests from health care professionals and internal stakeholders as needed. - Performs quality review of Medical Information case documentation and recorded calls as needed. - Ensures case correction and provides feedback and retraining to internal and external team members as needed. - Contributes to interdepartmental projects and supports the provision of medical, scientific, and technical information regarding Otsuka products as needed. Qualifications - Pharmacist (PharmD, RPh) or life sciences degree. - Minimum of 5 years of experience in pharmaceutical/biotech medical information and contact center activities. - Excellent written, verbal, and interpersonal communication skills. - Working knowledge of regulatory requirements surrounding medical information, pharmacovigilance (PV)/adverse event (AE), and product quality complaint (PQC) case reporting. - Ability to perform independently and efficiently in a fast-paced, demanding environment. - Must be proactive with a strong sense of urgency. - Must have the ability to pivot and work with different cross-functional teams. - Must have business acumen and strong analytic, strategic, and problem-solving skills. - Excellent computer skills using MS Office suite (Word, Excel, PowerPoint) and experience using Outlook & Microsoft Teams. - Important candidate qualities include: good work ethic, consistency, commitment, teamwork, collaboration, etc. - Annual travel up to 25%. Competencies - Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. - Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. - Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. - Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. - Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. - Empowered Development - Play an active role in professional development as a business imperative. Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits.

Role Description The Associate Director will serve as a key member of the Learning Center of Excellence within Global Quality, responsible for designing, implementing, and sustaining high-impact training programs for Commercial and General & Administrative (G&A) functions. This role ensures that learning strategies align with regulatory requirements, corporate standards, and business objectives, fostering a culture of compliance, quality, and continuous improvement across global operations. - Learning Strategy & Design: - Develop and execute a comprehensive training strategy for Commercial and G&A teams in alignment with Global Quality standards and business priorities. - Partner with functional leaders to identify learning needs, compliance gaps, and performance improvement opportunities. - Program Development & Delivery: - Design engaging, scalable, and compliant learning solutions (e.g., instructor-led, virtual, e-learning) tailored to diverse audiences. - Oversee the creation and maintenance of training content, ensuring accuracy, relevance, and adherence to regulatory guidelines. - Governance & Compliance: - Ensure all training programs meet global regulatory requirements and internal quality standards. - Monitor training effectiveness and maintain audit-ready documentation for inspections. - Stakeholder Engagement: - Collaborate with cross-functional teams, including Commercial, HR, Legal, and IT, to drive adoption and continuous improvement of learning initiatives. - Act as a trusted advisor to senior leadership on training trends, compliance risks, and capability-building strategies. - Metrics & Continuous Improvement: - Define KPIs and leverage data analytics to measure training impact and drive enhancements. - Stay current with industry best practices, emerging technologies, and regulatory changes to evolve learning programs. Qualifications - Bachelor’s degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred. - 8+ years of experience in learning and development, preferably within the pharmaceutical, biotech, or healthcare industry. - Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.). - Proven ability to design and deliver impactful learning programs using adult learning principles. - Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies. - Proven experience designing and implementing global training programs for Commercial and G&A functions. - Expertise in instructional design, adult learning principles, and digital learning technologies. - Excellent communication, stakeholder management, and project leadership skills. Preferred Attributes - Strategic thinker with a passion for scientific learning and development. - Agile and adaptable in a fast-paced, matrixed environment. - Strong project management and organizational skills. - Committed to fostering innovation, compliance, and continuous improvement through learning. Competencies - Accountability for Results: Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. - Strategic Thinking & Problem Solving: Make decisions considering the long-term impact to customers, patients, employees, and the business. - Patient & Customer Centricity: Maintain an ongoing focus on the needs of our customers and/or key stakeholders. - Impactful Communication: Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. - Respectful Collaboration: Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. - Empowered Development: Play an active role in professional development as a business imperative. Requirements - Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity. - This range represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. - Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. - Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits.

Role Description The Sr. Manager, Medical Writing role will be responsible for managing in-house and/or contract medical writers, leading and advising on medical writing strategies for individual project teams, and contributing to the management of operational plans and innovative solutions for all medical writing activities across OPDC. - Proactively manages writing activities across diverse therapeutic programs, ensuring adherence to the medical writing strategy and alignment with business needs. - Contributes to therapeutic project teams as the medical writing expert for clinical and regulatory submission documents. - Authors deliverables with consideration for regulatory, corporate, departmental, and quality standards. - Manages and provides mentorship of in-house and/or contract Medical Writing Staff. - Authors/edits regulatory submission documents, or reviews deliverables produced by the team. - Adheres to the global Medical Writing team’s practices and utilizes available systems and tools to support document development. - Engages with team members to ensure medical writing continues to deliver value to the business. - Ensures medical writing activities meet quality standards and adhere to applicable corporate SOPs, WPs, policies, guidelines, and regulations. - Provides training and communications to internal stakeholders regarding medical writing processes and best practices. - Reviews new ICH and FDA guidelines regarding medical writing and evaluates their impact on the organization. - Supports innovation initiatives within the Medical Writing Group and/or represents Medical Writing in other departmental innovation initiatives. Qualifications - At least 8 years of pharmaceutical/biotechnology experience. - 6+ years of medical writing experience in Pharma, Biotech, and/or CRO. - Demonstrated expertise in writing/developing clinical documents in support of regulatory submissions globally. - Ability to interpret and organize scientific and clinical data. - Previous supervisory or mentorship experience preferred. - Excellent project management and communication skills. - Ability to work with cross-functional teams in a highly matrixed environment. - Ability to identify process improvements and contribute to their implementation. - Ability to proactively escalate issues and provide solutions to problems. - Excellent computer skills including MS Office (Word, Excel, PowerPoint, Outlook). - Excellent written and verbal skills. - Embraces change and has a flexible and innovative mindset. Requirements - BA/BS in Life Science with a Master's degree strongly preferred. Benefits - Comprehensive medical, dental, vision, and prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits.

Role Description Senior Director, Global Medical Safety physician (psychedelics), leads and supports safety team(s) in all aspects of pharmacovigilance and risk management activities for assigned products, both marketed and in development. This role will provide proactive strategic and operational safety leadership for Otsuka’s late-stage psychedelic development portfolio (~4 assets). S/he will serve as the medical safety lead for investigational psychedelic compounds, ensuring proactive identification, assessment, communication and mitigation of safety risks in a highly specialized and evolving therapeutic landscape. The role requires deep expertise in clinical safety, neuropsychiatric risk assessment and benefit-risk evaluation, strong strategic mindset combined with the ability to navigate the unique clinical, operational, ethical and regulatory considerations associated with psychedelic compounds. S/he will establish a robust safety strategy that supports accelerated development, while maintaining the highest standards of patient safety and scientific integrity. The Safety physician will partner closely with the Medical Safety Therapeutic Area Lead, Head of Medical Safety, Head of Global PV (GPV), Global Clinical Development (GCD), Clinical Management (CM) and Global Regulatory Affairs (GRA) Biometrics, and Translation Medicine to identify, evaluate and communicate safety issues relevant to psychedelic portfolio. Qualifications - MD degree (required) with US medical license (preferred). - Demonstrated experience (at least 10 years) as a Safety/PV professional in pharmaceutical industry. - Ability to act as in-house authority/leader in Global Pharmacovigilance; and be fully accountable for Safety of assigned products. - High level of medical competence, with an ability to balance this with industry standards to achieve business goals. - A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities. - Able to work across therapeutic areas and functions. - Works collaboratively (establishes shared purpose across boundaries). - Develops people and the organization (invests in long-term development of others). - Experience interacting with global regulatory authorities. Requirements - Ability to lead and operate in a highly ambiguous and evolving regulatory and scientific space. - Strong decision-making ability within a rapidly evolving external landscape. - Exceptional communication and cross-functional collaboration. - Ability to influence without authority. - Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources. - Self-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous high priority tasks. - Ability to adapt to a dynamic work environment and drive safety initiatives. Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits. Company Description Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

Role Description The Director will lead activities related to Early Clinical Development (ECD) essential to the growth of Otsuka’s discovery and early phase pipeline within OPDC’s Early Development Organization (EDO). Reporting to the ECD Nephrology/Immunology (N/I) Therapeutic Area Head, this Director is a strategic scientific and clinical leader accountable for the end-to-end early clinical development strategy and execution for Otsuka's early phase portfolio, with emphasis on N/I indications, including but not limited to immunologic and inflammatory diseases in nephrology, rheumatology, immunology, and dermatology. The role shapes program strategy from indication selection through early clinical development (pre-IND through first-in-human and clinical proof of concept) and go/go no decisions based on clinical and/or biomarker driven endpoints ensuring seamless integration across discovery, nonclinical, clinical pharmacology, regulatory, and commercial functions. The Director, ECD – N/I, in alignment with the ECD therapeutic area head and functional head VP, collaborates with EDO senior leaders to identify, introduce, and implement translational tools or studies for discovery and early phase programs and establish strategic plans and objectives. Key Responsibilities - Serve as scientific and clinical expert in N/I translational medicine and early clinical development, contributing to strategic program decisions; serve as ECD lead on development teams for multiple assets. - Drive Research-to-Development (R2D) strategies and stage-gate decision-making, including indication prioritization and go/no-go based on mechanistic rationale, benefit-risk, and clinical unmet need as well as on clinical and/or biomarker driven endpoints. - Prepare and present decision-quality data packages for internal governance reviews to support stage-gate decisions. - Interact with internal and external groups to evaluate new compounds, molecular and biological targets as well as new formulation technologies. - Partner with internal and external research organizations to expand and facilitate development of early phase and discovery phase compounds. - Engage with external experts and key opinion leaders to inform translational and Proof of Concept (PoC) strategy and maintain scientific leadership. - Represent ECD in cross functional as well as internal/external collaborations (BD, etc.) on activities related to early phase target and asset identification. - Support regulatory interactions (e.g., pre-IND, IND submissions) and ensure translational strategies align with regulatory requirements. - Lead scientific and clinical development efforts for assigned programs from target identification through IND and proof-of-concept. - Provide medical leadership for early-phase clinical protocols, informed consent forms, and investigator brochures; monitor safety and contribute to DSMB or safety review activities as needed. - Support or lead public-private partnerships operating in pre-competitive settings to advance internal clinical development capabilities. - Interact with other disciplines within the EDO to promote, initiate and elevate cross-functional early development activities. - Collaborate with biomarker and digital innovation teams to develop and implement biomarker-driven approaches for N/I programs. - Support the development of team members to build translational and early clinical development expertise. - Travel 20%. Qualifications - Required: MD or MD/PhD with specialty/training in nephrology, rheumatology or immunology. Dermatologists with immunologic/inflammatory skin disease expertise may also be considered. - 5+ years of translational medicine and/or early clinical development experience with a track record of advancing biologics and/or small molecules through IND and FIH/PoC. - Expert understanding of industry best practices and adjacent functional areas. - Demonstrated ability to coordinate and guide cross-functional teams in matrixed, global setting, with solid strategic thinking and the ability to make informed decisions amid uncertainty. - Outstanding communication skills with the ability to synthesize complex data and influence executive stakeholders. Preferred - Deep expertise in N/I, particularly nephrology, rheumatology or immunology. - Experience implementing clinical study plans to drive decision-making. - Experience with external collaborations. Competencies - Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. - Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. - Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. - Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. - Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. - Empowered Development - Play an active role in professional development as a business imperative. Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits. Application Deadline This will be posted for a minimum of 5 business days.

Role Description The Senior Director, Data and AI Engineering will be a visionary and strategic leader responsible for defining and executing the data and AI engineering strategy across the entire R&D value chain with a deep knowledge of AI and R&D Data. This role will empower scientific and business functions—including drug development, clinical trials, real-world data evidence—by delivering robust, scalable, and compliant data and AI foundations and implementing advanced data, AI, and Generative AI (Gen AI) solutions. As a technical leader, the Senior Director will manage a high-performing team of data engineers, AI/MLOps specialists, and application support team to foster a culture of innovation, and ensure the adoption of best-in-class engineering practices within a regulated pharmaceutical environment. This leader will bridge the gap between scientific ambition and technical execution, translating complex R&D challenges into impactful data and AI engineering solutions. The Data and AI Engineering team will focus on establishing and enhancing Otsuka’s Data and AI solutions foundations on top of the AI platform provided by Data and AI platform team in IT. Qualifications - Expertise in real-world data assets and using them to generate scientific evidence and guide operational effectiveness and efficiencies. - Deep expertise across data engineering, representation, Gen AI, AI, and machine learning techniques and experience in architecting and delivering AI/ML use cases. - Strong team leadership, internal and cross-functional collaboration, project management skills with a focus on delivering impactful initiatives. - 12+ years of progressive leadership experience in data engineering, AI/ML, and Gen AI with at least 5 years in senior technical leadership or management roles. - Strong and demonstrated experience in architecting, building, and maintaining large-scale data and AI solutions in a scientific, regulated, or research-heavy environment. - Strong experience working within the pharmaceutical, biotech, or life sciences industry, particularly within R&D, is highly desirable along with a deep understanding of AI and Machine Learning and its applications in Pharma. - Proven track record of implementing and deploying Gen AI and large language model (LLM) applications in production environments. - Creative problem solving using responsible use of technology. Requirements - Define and drive the strategic vision and roadmap for data engineering, AI, and Gen AI capabilities within R&D, aligning with overall business objectives and scientific priorities. - Serve as a key thought leader and trusted advisor to senior R&D leadership on opportunities and risks related to AI and data technologies. - Evaluate and adopt emerging data and AI technologies, balancing new opportunities with the need for scalability, reliability, and regulatory compliance. - Deliver leading edge engineering approaches, effective enterprise data strategy, robust and responsible AI/ML model development. - Lead and deliver the design, development, and deployment of extensible and scalable data engineering for complex R&D Data, pipelines, and architecture for AI applications. - Oversee the implementation of AI and Gen AI use cases from ideation to production deployment. - Champion engineering best practices, review AI solution architectures, and data & AI observability. - Architect and scale MLOps practices for in-house applications to support the entire model lifecycle. - Drive awareness of AI/ML applications and the importance of strong Data and AI engineering foundation across the organization. - Provide technical and engineering support for Data and Information Governance, quality, and FAIR data. Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits.