Director, Early Clinical Development - Nephrology/Immunology (N/I) locations Remote time type Full time job requisition id R11967 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. Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity: The range shown 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. This information is provided to applicants in accordance with states and local laws. Application Deadline: This will be posted for a minimum of 5 business days. Company 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 as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka. Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 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.

Director, Global Quality GMP Processes locations Remote time type Full time job requisition id R10651 The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for benchmarking, standardizing, and optimizing global quality processes across the organization. This role ensures that product quality systems are aligned with Good Manufacturing Practices (GMP) and regulatory requirements while driving efficiency, consistency, and continuous improvement across all regions and product lines. The Director will lead global initiatives to harmonize and enhance processes related to product quality complaints, deviations, CAPA, and management reporting, ensuring timely and effective resolution and robust compliance. Key Responsibilities - Global Process Ownership: Lead the design, implementation, and continuous improvement of global quality processes for: - Product Quality Complaints - Corrective and Preventive Actions (CAPA) - Deviations - Management Reporting and Trending - Benchmarking & Best Practices: Evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency. - GMP Compliance: Ensure all quality processes meet global regulatory requirements (e.g., FDA, EMA, PMDA) and align with current GMP standards. - Governance & Standardization: Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all manufacturing sites and affiliates. - Quality Systems Leadership: Oversee the global deployment and optimization of electronic quality systems (e.g., TrackWise), including configuration, training, and validation. - Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies. - Data-Driven Insights: In collaboration with Quality Operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making. - Team Leadership: Build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence. Qualifications Required Required Qualifications: - Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred. - Minimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role. - Deep understanding of GMP regulations and global regulatory requirements (e.g., 21 CFR Parts 210, 211, 820). - Proven experience in managing global quality systems and optimizing complaint, CAPA, and deviation processes. - Strong analytical and problem-solving skills with a data-driven mindset. - Excellent communication, leadership, and stakeholder management skills. - Proficiency in quality management systems (e.g., TrackWise) and Microsoft Office tools. - Ability to travel internationally as needed. Preferred - Basic understanding of artificial intelligence and advanced analytics - Experience supporting risk management programs or frameworks. - Familiarity with quality management systems and digital tools. 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. Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity: The range shown 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. This information is provided to applicants in accordance with states and local laws. Application Deadline: This will be posted for a minimum of 5 business days. Company 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 as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka. Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 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. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request. Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

• Provide strategic leadership for Field Insights & Analytics across the full Neuroscience and Renal portfolio. • Oversee insight generation and decision support across a diverse set of in-market brands and evolving portfolio priorities. • Ensure that insights and recommendations reflect the needs of a broad, multi-brand, multi-asset portfolio. • Serve as the front door to Insights & Analytics for field leaders across the Neuroscience and Renal portfolios. • Engage directly with field leaders and General Managers across multiple brands and assets to align insights to business priorities and support timely decision-making. • Build trusted partnerships by translating analytics into clear implications, strategic choices, and actionable recommendations. • Deliver proactive, integrated insights that influence portfolio, brand, and field strategy across Neuroscience and Renal. • Connect field realities, market context, and cross-functional analytics to identify risks, opportunities, and strategic implications. • Serve as a trusted thought partner to senior stakeholders by shaping executive-ready narratives that support high-quality decision-making. • Lead adoption and maturation of standardized Insights and Analytics / Field Insights Analytics-aligned analytics frameworks anchored to enterprise and portfolio KBQs. • Ensure consistency in metrics, methodologies, and insight generation across brands and assets. • Drive the use of structured analytics approaches that enable scalable, repeatable decision support across the portfolio. • Lead field data strategy across Neuroscience and Renal in partnership with Insights and Analytics capability teams. • Ensure field data and analytics outputs are relevant, scalable, and fit for strategic and operational decision-making. • Manage and develop the Associate Director focused on the Renal portfolio and ensure strong alignment between renal portfolio support and broader Neuroscience & Rare Disease priorities. • Own disciplined planning, tracking, and execution of field analytics initiatives across the Neuroscience and Renal portfolios.

• Leverage scientific, economic value, managed care expertise and market knowledge to establish/build professional relationships and proactively engage with PHDMs in priority accounts as aligned with medical and Market Access strategy, including emerging data discussions, uncovering and addressing medically related access barriers in the patient journey, understanding market dynamics within the territory, pipeline discussions, disease state and product education, addressing unsolicited requests, and capturing PHDM-related insights across all stages of the product lifecycle. • Demonstrate strategic National and Regional vision by identifying, mapping, and planning PHDM engagement and Key Accounts aligned to medical launch strategy, including creating and maintaining strategic medical plans for each National and Regional account. • Identify emerging PHDMs/influencers and related entities as the healthcare market evolves and collaborate effectively and compliantly with all field partners and internal colleagues. • Regularly and effectively collaborate with internal colleagues (Market Access, HEOR, MSLs, RMLs, etc.) across launch brands and new indications (Oncology, Cardiovascular, Renal, Immunology, Neuroscience) to advance shared or aligned objectives while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards. • Deliver thought leadership around product lead opportunities and represent the VEL perspective in internal work streams as assigned. • Maintain in-depth knowledge of assigned Novartis launch compounds and new indications to serve as a medical resource to customers and internal colleagues, and represent Novartis at national clinical, value evidence, and managed markets congresses to support continuous knowledge development in the US healthcare market space. • Achieve agreed-upon team/personal objectives related to launch/prelaunch products, activities, and other VEL-related goals, and utilize key metrics/KPIs to identify best practice and drive continuous VEL improvement. • Maintain in-depth knowledge of internal policies and external regulations, including field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, and institutional policies, and understand how they affect day-to-day responsibilities. • Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling core customers and ensuring up-to-date information in the CRM. • Champion emerging responsibilities as strategic priorities evolve, proactively drive personal and professional development, and conduct oneself with the highest ethical standards in adherence with the Novartis Code of Conduct, all relevant laws and regulations, and Novartis Ethics, Risk & Compliance policies and procedures.