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The Associate Director of Internal Controls is responsible for defining and assessing control objectives and monitoring compliance of the accounting and financial JSOX controls at Otsuka. This individual will review test findings from both the Internal/External Audit Team, facilitate the remediation of control gaps, and escalate possible critical issues to the senior leadership team. The Associate Director of Internal Controls will identify areas of potential improvement for key processes and procedures and supports the management of the related processes and procedures. He/she will be responsible for working with different business owners to partner on implementation, execution and compliance with entity level controls, while formalizing the assessment and improvement of the JSOX control structure. The Associate Director of Internal Controls will lead the creation and maintenance of a highly effective control structure, have high visibility to Senior Management and be viewed as the subject matter expert for internal controls. Maintain the Control Environment and ensure the control framework is strictly implemented and maintained across all organizations. Ensure JSOX controls are optimized, implemented and enforced for each business process. Establish working relationships with business leaders and executive management to build an awareness of the importance of a strong internal control environment. Establish close working relationships with external auditors for all JSOX related issues. Reach agreement on a scope and testing strategy. Ensure appropriate resolution and agreement during each phase of the annual process including documentation, walkthroughs and testing. Develop audit plans and execute audits of various business processes using established or new audittechniques, including writing audit finding, recommendations and presenting to senior leadership. Implement a process of continuous improvement that enhances a well-controlled business environment, while emphasizing control automation that minimizes disruption to the day to day process of the business. Build a strong working relationship with the parent company Internal Audit team. Assist in the coordination of audits and provide guidance to the business on process improvements with actionable plans. Research new accounting standards. Prepare analysis of the accounting treatment and financial impact of the new standard. Coordinate and conduct the quarterly Audit Committee meeting and annual Disclosure Committee. Oversee the coordination and development of policies and procedures. Lead direct reports in day to day activities.
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The Director, Population Health Digital Medicine is responsible for leading health economic and outcomes research studies working with cross-functional teams. Responsibilities will also include but not limited to the following: - Development and implementation of evidence generation strategies including health system level process of care/quality improvement studies. - Will work collaboratively across internal and external stakeholders to focus research and associated communications to support the clinical, economic and humanistic value proposition associated with the Otsuka Digital Medicine portfolio. - Design and implement health economics and outcomes research strategies and associated studies that support the clinical, economic, and patient centered value propositions, as well as reimbursement requirements for Otsuka products and therapeutic areas of interest (primary focus in the US).- Generate and communicate evidence to support the value proposition of Digital Medicines to inform/support product reimbursement discussions and value-based contracting.- Supports the development of clinical, economic, and patient centered value propositions related to Digital Medicine -Assists cross-functional teams in developing and communicating product value propositions in support of policy and coverage decisions consistent with FDA guidelines for communication of healthcare economic information.- Develop product dossiers and other projects that support different aspects of formulary review and submissions.- Develop process and quality of care tools to support formulary decision making and treatment of appropriate populations.- Supports training of field-based medical and access personnel.- Participate in various cross-functional project team and leadership meetings. - Identify and oversee vendor activities in support of evidence generation activities within budget and quality expectations.- Represent Otsuka at external professional, scientific meetings and forums- Support preparation payer advisory meetings to solicit feedback on Otsuka products and therapeutic areas specific disease impacts.- Works collaboratively with market access team to support the development of US pricing and reimbursement strategies.
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• Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components. • They will demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies. • May be assigned additional responsibilities as deemed necessary.• Develop and maintain Target Product Profile, Company Core Data Sheet (CCDS) and local labels (US, EU, Canada)• Evaluate and communicate risks associated with CCDS content updates and implementation strategies• Understand and address key scientific, clinical, medical and payer needs, including commercial differentiation strategies• Assess competitor labeling - understand precedents & opportunities for Health Authority (HA) discussions• Understand implications for promotional and HTAs from local labeling• Support global HA interaction strategy to discuss key labeling elements• During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies• Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approval • Contributes to the continuous improvement of the end-to-end labeling process• Ensures that all labeling components (for new and existing product labels and labeling) are appropriately developed and maintained according to relevant laws and regulations.• Responds to labeling request changes in an efficient manner to meet required timelines.• Support all tracking, planning and storage activities related to labeling including any computer or manual system related activities• Support inspection readiness activities related to all global labeling components• Follows and formulate improvements to labeling policies, processes, quality, and system tools.• Ensure policies and practices are maintained to ensure local labels are consistent with global labeling• Present to Labeling Oversight Committee: Ensure Core Data Sheet accurately reflects current understanding of benefit/risk profile.• Leads or contributes to cross functional teams: Labeling Committees, Labeling Teams, and provides direction and support and leadership to Product Review Council teams, Legal and other groups as needed.• Analyses and interprets new regulations and Guidances as well as monitors and determines their impact on product labeling. Provides strategic advice on implementing new regulations as well as provides input for development of promotional messages as needed.
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- The Director, Medical Affairs Digital Medicine will coordinate the analysis of the IT aspects of target technologies and interface with appropriate IT experts. - Work with the team to develop methodologies for clinical decision analytics. - Work collaboratively with Medical/Population health VP, other internal as well as external stakeholders to develop real-world clinical and health economic evidence- Participate in preparation of publications and presentational materials and participate in internal and external presentations of that material.- Coordinates the analysis of the IT aspects of target technologies and interface with appropriate IT experts. - Drive preparation of publications and presentational materials and participate in internal and external presentations of that material.- Provides medical input to all aspects of product development- Reviews clinical results and develops appropriate communication vehicles (i.e., publications, posters, presentations, PR, etc.).- Provides direction for medical information team.- Participates in extramural conferences and scientific meetings to maintain awareness of research in the field.- Keeps abreast of current state-of-the-art developments relating to in-house medical program focus, and provides education to clinical staff and other project team members, as needed.- Provide medical guidance regarding appropriate HCP specialties Target Review As needed, assists Senior Director in evaluating potential business opportunities.
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To be a credible source of evidence based information that demonstrates the value of Otsuka products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers and other key stakeholders to apply practical real-world solutions to improve patient outcomes. Key Job Responsibilities:- Ensure appropriate dissemination of clinical information, knowledge and services in a timely, ethical, and customer-focused manner.- Keep abreast of the current literature, therapeutic issues, and competitive landscape related to psychiatric disorders.- Establish status as a knowledgeable and trustworthy medical and scientific resource for opinion leaders with expertise and knowledge of supported product(s), treatment trends, clinical trials, and scientific research.- Communicate current and emerging clinical research data to opinion leaders in response to unsolicited inquiries.- Identify medical experts to provide services as speakers, consultants, and investigators.- Engage national, regional and local payers, payer advisors and influencers that make patient access and reimbursement decisions.- Communicate cost effectiveness evidence that address payer needs and priorities; partner with providers and payers to put into practice decision support and care management tools and apply real-world evidence and solutions in the practice setting.- Deliver scientifically focused balanced and objective educational presentations to groups of strategic importance such as hospital and payer P&T committees.- Train speakers for promotional programs on product knowledge, clinical/scientific data, and information consistent with established company policies and compliance guidelines.- Participate and interact with opinion leaders, local practice leaders and other key stakeholders, including preparing moderators at national, regional and local conferences, advisory boards and other approved gatherings.- Gather scientific and competitive intelligence as well as customer insights during interactions with opinion and practice leaders or attendance of congresses and communicate to relevant Medical Affairs and Clinical Development personal.- Evaluate and assess potential investigational sites for participation in Otsuka-sponsored clinical studies as well as educate investigators about the study drug and pharmacovigilance procedures.
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The Senior Director, Regulatory Affairs provides regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures development of drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Works with Regulatory Management to establish well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval. Additional responsibilities include but not limited to the following:- General regulatory experience supporting pre-clinical to clinical domains for investigational products- Candidate will have specific digital health experience & the ability to shape policy in this space- Desire to pioneer new regulatory strategies and pathways within the digital space- Candidate who will proactively drive new regulatory policies by developing a strong relationship with key leaders at FDA and forging a true partnership with regulators- Resource that can see the entire landscape and negotiate across constituents and may even be able to build bridges between CDER and CDRH- Candidate would work closely with Strategic Partners product team to evolve product strategy as they work with FDA to impact policy so that we are a step ahead to keep product relevant- Resource should proactively monitor the federal register, understand the FDA position, work with internal stakeholders to craft Otsuka position, liaise with Strategic Partner to understand their perspective and negotiate across all stakeholders to our desired outcome (Strategist that can 1) evaluate our probability of technical & regulatory success (PTRS) 2) identify gaps in our label and 3) build an executable strategy to address those gaps- Individual who can work alongside medical/population health leader to build evidence to support the value prop
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The Director, Global Clinical Development will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The incumbent will be responsible for the evaluation and clinical development of Cardio-renal, Metabolic and General Medical products at different stages of development for a global health-care market. Additional responsibilities include but not limited to the following: - Existing positions at Otsuka seek general clinical development/research experience to support Phase 1 through 3 to clinical studies for investigational products, whereas we are looking for someone with specific phase 4 real-world evidence experience - Experience generating real-world evidence studies through phase IV studies in order to support value proposition of digital product in the market place- Candidates would have pragmatic clinical trial experience focused on showing clinical outcomes- Abilify to design trials to inform clinical and health policy decisions by evaluating the risks and benefits of health interventions in real-world, clinical practice settings - GCD representative will be responsible for engaging with health systems and customers- Oversee design and execution of all studies involving digimeds (clinical, RWE, burst and ISTs)- Position will also be responsible for interpreting data results from clinical studies- Work closely with Strategic Partners product team & contribute to planned product enhancements and product releases- Consults with clinical, regulatory and scientific leaders to optimize trial design; including objectives and endpoints- Will help lead and support regulatory filing activities and documents- Provides strategic direction and editing to provide concise, clear and convincing argumentation in all written and verbal communications
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Reporting into Director - Solution Architecture and Technology Enablement, this position will be responsible for successful outcomes on technology aspects of implementing and deploying technology products (both COTS and custom/bespoke), application development using modern technologies, following industry best practices and working closely with influencers and stakeholders - Business, Technologists, Quality, Security, Testing and Support throughout all phases of software development lifecycle. This role is techno-functional. Technology-wise, the role is accountable for developing and managing the technology solutions implementation strategy, technical design, guide and lead the development team, interact with other development teams in a variety of technologies, Social, Mobility, Analytics, Cloud and Internet of Things. The role is a go to technology subject matter expert responsible to oversee, guide and lead technical solutions in support of integrated/connected global R&D systems serving business users worldwide across Otsuka and its affiliates. The role ensures system design and technology maps to the business needs, is scalable, sustainable, supportable, and has life cycle management plans.In addition, candidate is responsible to manage the forward-looking technology strategies, solutions and integration solutions, technical deliverables, and solutions roadmaps. The business domain includes mainly regulatory and quality and understanding of other domains like clinical, technical operations, research would be very helpful. In this role, candidate is required to build and manage working relationship with managed outsourced service providers essential to ensure quality and timely deliverables that meet the future proof solutions specifications. Candidate will have accountability for ensuring alignment of technology solutions that meets and supports the business processes, integration standards, and reinforcing best practices and guidelines. The incumbent will liaise with architecture team, other development team, business information managers to understand the business context, user experience, and operational support needs of the developed solutions. The job role requires deeper understanding of all phases of technology implementation with greater emphasis on technical product management, release management, common technology architectural standards such as modern programming languages, Service Oriented Designs and Integrations, Data Warehouse, Business Intelligence and analytics, Middleware, Big Data technologies, Cloud technologies, application design and user experience designs. Key Job Responsibilities- Engage with different roles and function to provide architectural overview of proposed solutions outlining components, relationships and dependencies that will serve as the primary basis of timely decision making.- Collaborate and partner across lines of business and the IT groups in order to understand strategic drivers and tactical needs to ensure implementation teams can provide technically innovative solutions that meet the business needs with the necessary usability, technical stability and scalability.- Produces information flows, architecture, technology roadmaps and technical implementation blueprints in close alignment with business capability roadmaps.- Ensure solutions being developed has longer life span, takes global needs into accounts, architecturally flexible to extend to related business areas and affiliates ensuring maintainability and supportability of systems.- Supports projects and operational activities in the Global R&D solutions portfolio. Participates in the identification, evaluation and development of concepts for IT solutions by providing technical expertise and oversight of the development of prototypes and proofs of concepts.- Analyzes business scenarios and identifies opportunities for technically innovative solutions and improvements. Provides technical expertise in designing and developing systems and procedures that are cost effective and meet user requirements by complying with the Otsuka technology standards and by proposing new and upcoming technologies- Leads specialist resources on technical issues within the domain on content and provides detailed analysis of the operations and opportunities for improvement.- Creates and owns the Solution Architecture documentation and works closely with the technical team (Technical Project Manager, Lead Developer, developers/software engineers, testers) to monitor technical development of solutions; configures the system when necessary.- Actively participates in Architecture Community of Practice internally and/or externally (industry forums, vendors etc.)- Ensure that Solutions are technically/ architecturally consistent, fit for purpose, meet customer requirements and comply with all relevant IT and business standards such as reuse of technologies and solutions, and simplicity and usability.- Actively seeks and drives opportunities for continuous improvement of applications, during teams project work and for internal processes.- Directs and influences appropriate support teams (internal and third party) to ensure service levels are met.- Ensures support of key business processes and appropriate levels of integration / automation- Helps bridge the gaps and hand-offs issues between requirements / functional resources, development teams, and project leadership / sponsorship- Provides leadership to ensure that capabilities delivered align with original business objectives, application service levels, IT strategies, and design intent- Promotes data ownership and governance practices within business partner organizations- Influences business requirements and priorities- Synthesizes and communicates complex technical and business information easily to senior management and business stakeholdersDevelops strategy and execution plans for implementation of cutting-edge technologies and processes while managing the ongoing needs of application development and support. Works within IT and with other cross-functional groups and with vendors, to successfully identify, prioritize, and resolve issues and works on enhancements, developments, and operational improvementsEnsure solutions being developed are future proof while considering Otsuka global needs into account, and developing architecturally flexible solutions to extend to related business areas and Otsuka affiliates and ensuring maintainability and supportability of systems
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OTSUKA - PEOPLE CREATING NEW PRODUCTS FOR BETTER HEALTH WORLDWIDEWe are looking for talented individuals to join our ReadyNow Sales Development Program! If you demonstrate a high tolerance for ambiguity, can work in a fast-paced, ever-changing environment, and have a desire to experience living in different parts of the country, this may be the perfect opportunity for you. HOW IT WORKSIn this role, you will be joining a team of new-to-industry professionals and will commit to up to 18 months of travel rotations across the nation. Upon completion of full product training, you will be deployed into field territories on rotation assignments lasting approximately 3-4 months each. After completion of each rotation, your new rotation location will be determined based on business needs. Watch this short video to hear from previous ReadyNow reps about being a part of this innovative program: Ready-Now Program What’s your ultimate goal along the way? Your goal should be to gain a permanent position as an account manager following completion of the program. What you have to do? During each of your rotations, learn as much as possible. Follow guidelines and compliance regulations. Work successfully with your assigned District Managers and other account managers to manage each territory and drive sales results. Permanent placement isn’t guaranteed, so you’ll have to demonstrate that you have what it takes to be a star on our Sales team!
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The Data Scientist at Otsuka will support a diverse array of initiatives including advanced computational modeling, clinical data analysis and development strategies (with particular focus on digital programs), and software development projects. Initially, this role will have particular focus on Otsuka’s Digital Medicine Accelerator Lab. Specific responsibilities include, but are not limited to:- Working closely with stakeholders interfacing with clinical and real-world data to identify, enhance, and support the quantitative and technological needs for all Otsuka projects- Extract complex data into actionable insights that empower others to drive operational strategic initiatives.- Provide statistical and modeling support for planning and implementing clinical and real-world evidence studies/program and conduct analyses related to time series modeling, supervised and unsupervised learning techniques.- Demonstrated ability to engage in effective joint problem-solving to address key challenges and collaborate with team members to meet project checkpoints and accomplish team objectives.
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The Clinical Management team skillfully executes all phases of clinical trials for all portfolio assets across OPDC. We break from traditional clinical operations and utilize strategies at the intersection of technology and therapeutics, and have been transforming the clinical trial model in the process. We deliver high quality clinical trial data and submissions while defining the new wave of clinical trial execution.Do you want to do extraordinary things and have an impact on the future of our business?- Acts as the scientific lead for clinical program development activities within a product group or within a portfolio.- Determines product and portfolio level standards for clinical development planning, scientific document content, data analysis and reporting, and reporting to senior management, OPCJ and affiliates.- Ensures that scientific content of development plans and protocols meets requirements for simultaneous regulatory submission and optimal market access.- Supports Medical Affairs and other functional areas in reporting program activities and results.- Serves as a“resident expert” within OPDC for issues related to clinical development planning, program management, and internal reporting.- May directly supervise clinical management personnel. May serve as a member of the Clinical Management Leadership Team.- Contributes to the preparation and defense of clinical program documents (investigator brochure/IMPD, IND/CTA annual reports, Health Authority briefing books and submissions (NDA, MA, NDS etc.), including ongoing maintenance of filings and support of labeling teams.- Leads development of clinical sections of regulatory documents (i.e. Investigators’ Brochures, briefing books, submission dossier, and responses to Health Authorities questions) and inspection readiness programs, where appropriate.- Coordinates and/or supports program level inspection readiness strategies in preparation for and defense of global regulatory filings and ongoing marketed products.- Represents assigned programs to senior management and OPCJ, and disseminate information and tasks to team members.- Assists Senior Director with departmental resourcing activities.- Gives direction, training, and support to Clinical Management personnel within portfolio/compound team. Assists supervisors in skill set development activities.- Leads assigned departmental, External Service Provider partnership, and corporate standardization and continuous improvement efforts for issues relating to program design and execution.- Analyzes best scientific conduct and planning practices across products and portfolios. Designs and implements plans to incorporate practices- Researches and investigates industry best practices in the areas of clinical development planning, and endpoint design/validation/reporting. Shares OPDC best practices in industry-wide forums.- Review clinical trial data utilizing electronic surveillance output- Coordinate and oversee review, analysis and interpretation of data including the development of clinical study reports, publications and internal/external presentations.- Serve as support for global affiliates in relation to regulatory filings, trial implementation and training- Coordinate and oversee the development of program level financial estimates (eg, MLTE).- May be assigned supervisory duties- Participate in CRO partnership governance and alliance management activities as assigned, within and across programs and portfolios.- Represent Clinical Management interests in corporate and cross-affiliate initiatives, as assigned.- Participates in process and continuous improvement initiatives as assigned. This person will drive and embrace various change initiatives including technology integration.- May serve as member of program level teams including GBT/PDC /JDC/Alliance teams and presents to program level updates to senior management and team.- Develop strong scientific partnership with key advisors in assigned therapeutic area.- Lead program-related advisory boards/committees and meetings. - Communicates corporate decisions in a timely and effective manner through various venues to ensure staff are aware of updates to corporate culture, vision and management.- Other activities assigned
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The Director – Global R&D Clinical IT Business Information Management is accountable for identifying, qualifying, and driving adoption of technology solutions that drive measurable business outcomes for assigned business customers including but not limited to:- Customer relationship management- Strategic capability roadmaps and business requirements- Business and IT process Improvements, innovation and automation- Business-IT partnership- IT operational and fiscal accountabilities including investment strategies and long range operating plans- Near real time accessibility of R&D clinically significant data to drive greater insights and rapid decision making for clinical study portfolio- Data privacy, secrutiy, and accessibilityWe are currently seeking an experienced professional to work directly with our R&D Clinical business function, early and late stage clinical scientists, clinical data management and biostatistics, clinical innovation, transformation and process imporvements functions. Reporting directly to Global head of R&D IT, the Business Information Management Director will work across Global R&D IT Services to define and own our operating model and interactions across various shared services groups PMO, Infrastructure services, enterprise/solution architecture, internal and external service providers, vendors, contingent workers across IT and relevant business functions as well as applications Production Support functions to deliver the intended business and technology outcomes. The Director will play a key interface role with other IT services groups to ensure successful alignment, integration, and enablement of Otsuka and affiliate’s R&D Clinical business objectives with goal, objectives, and operational needs. Relationship Management:- Accountable for overall business relationship management. Act as an escalation point for assigned customer segments and ensure IT service delivery is aligned to business needs, requirements and expected outcomes.- Manage technology-related communications to cross-functional stakeholders across impacted organizations and functions.- Ensure that implementation projects and business production systems are delivering agreed upon value- Manage the business interface in order to assist business customers for all their IT needs through identification of appropriate contacts within IT who can address infrastructure, support or other enterprise-wide IT needsStrategic Technology Roadmap and Value Creation- Align and drive global technology initiatives in close partnership with the business to enable growth, productivity, and clean /quality auditable clinical data.- Develop business strategy, goals and objectives. Inform and influence business and IT strategies by bringing current knowledge, gaps, and future vision of technology and systems for competitive advantage.- Evaluate current technology stack and articulate strengths/weaknesses- Drive the definition of technology objectives and recommend industry-leading solutions to support business needs- Facilitate prioritization of technology needs with business customers- Develop a business aligned IT strategy and investment roadmap that addresses current and future needs operationally, tactically and strategically.Opportunity Qualification- Partner with the relevant stakeholders to identify business/IT improvement opportunities- Identify technology solutions to support business improvement- Evaluate technology solutions based on business value and identify trade-offs- Manage Otsuka’s R&D Clinical IT needs as a portfolio of projects- Develop and manage overall capability improvement strategy- Develop a detailed business case which provides high level business/user requirements, project schedule, costs, and resources and TCO/ROI /business value measurement- Promote and partner across relevant functions to constantly seek innovative fit-for-purpose capabilities for continuous improvements and business-IT innovation/ transformational goals and objectives.Business consultancy, financial and Operational Maintenance- Provide guidance and advice on changes required to support existing solutions- Create/ Review business case for technology upgrades and releases- Interface with other IT service groups to ensure successful alignment and enablement of Otsuka R&D clinical objectives- Incorporate yearly support budget into overall portfolio budget planning- Manage IT portfolio for the assigned business functions including portfolio creation, IT budget forecast and be accountable for financial outcomes.- Facilitate requirement workshops, identify and communicate industry/ IT trends, operational metrics, partner across organization to improve upon published KPIs as applicable.
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The supplier quality manager will monitor the External and Internal Audit Program for timely completion of required activities, and perform audits of third party manufacturers and suppliers, to ensure compliance with GMP regulations, contracted business agreements, and company policies. Applicable GMP regulations, will be all regulations required for manufacturing and distribution of drug products, medical devices, drug/device combination products, and clinical supplies for investigational use. The incumbent will collaborate with other departments, in addition to global affiliates and subsidiaries, to establish and maintain the effectiveness of the GMP External/Internal Audit programs. The position requires up to 50% travel; mostly domestic and occasional international travel may be required. - Support Global Product Quality lead to ensure that all required internal and external audits are planned and scheduled.- Leads and conducts audits of contractors and suppliers to ensure compliance with Global and Local Otsuka, and applicable regulatory requirements.- Ensure that audit documentation is accurate, complete, and issued within the required timeframe.- Review and approve CAPA plans for audit observations.- Interfaces with Contractors, Suppliers, Tech Operations, Technical Services and Supply Chain, and Clinical Supply Operations to drive Quality improvements that minimize the Costs of Quality, specifically for component, materials or finished product suppliers- Compiles and reports key performance indicators, metrics and compliance status of Internal Audits and GMP Outsourced Activities to Senior Management. Author Standard Operating Procedures, work instructions, forms, templates and other documents associated with the audit process as needed and for periodic review.- Works collaboratively within Global Product Quality and other functions across Otsuka Affiliates and Subsidiaries to ensure compliance to internal standards and regulatory requirements.- Assists in the development of training programs for inspection readiness and improvements with Internal Audit and Supplier Quality Programs along with other Quality Systems.- Participates in Inspection Readiness activities and supports Regulatory Inspections.- Support project teams to ensure that team goals are consistent with global and local quality objectives, in addition to government requirements.
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- Provides leadership and day-to-day guidance to internal and External Service Provider (ESP) study team for all protocols within an assigned program.- Ensures cross-study consistency in protocol design, data analysis and reporting.- Interacts with expert physicians, investigators, ESP personnel, and functional area staff to ensure program strategy and objectives are understood and implemented and to address program related issues and questions. Ensures compliance with FDA and international regulations, GCPs, and SOPs. - May supervise Managers, Clinical Trial Leads, Clinical Oversight Leads and/or Clinical Project Administrators.- Acts as the operational lead for a program (indication, formulation, phase, or other related clinical trials). Provides guidance to Clinical Trial Leads working within assigned program and ensures operational consistency across assigned clinical trials. Serves as a secondary contact for ESP, where Clinical Trial Lead serves as the primary contact.- Develops protocol outlines, protocols, amendments, and CRF standards- Reviews clinical trial data, focusing on data integrity, trending & consistency across the program. - Contributes to the review, analysis and interpretation of data including the development of clinical study reports, publications and internal/external presentations.- Serves as support for global affiliates in relation to regulatory filings, trial implementation and training- Contributes to the development of program level financial estimates (eg, MLTE).- Contribute to the preparation and defense of clinical program documents (eg. Investigator Brochure, responses to Health Authority questions, regulatory submissions).- Supports program level inspection readiness strategies.- Serves as supportive contact for Medical Affairs/PBS related to medical information requests, public disclosure of information (eg, clinicaltrials.gov) and publications strategies.- Develops and maintains current program level training materials- Provides program-level reporting to management.- Approves country selection for protocols within assigned program. Acts as final reviewer of proposed investigator list for clinical studies- Plans program-level risk mitigation strategies. Ensures that program activities are conducted following the protocol, ICH, GCP and all applicable global regulatory requirements.- Acts as Requestor of Service for protocol SOW.- Approves selection of appropriate study management personnel at ESP.- Oversees outsourced program committee activities.- If assigned supervisory duties:- Responsible for training and orienting new employee(s) on corporate culture, corporate expectations and departmental/organizational policies and procedures. Works with various groups to devise training program(s) for the employee and makes arrangements for such sessions to be conducted. Ensures the employee has access to all required material, systems to satisfy their individual job responsibilities.- Sets performance expectations for each direct report. Establishes a feedback loop among employee’s peers (on departmental and project teams). Provides specific and frequent feedback to the employee on his/her performance. Creates individual development plans.- Assures compliance with departmental, SOP, compliance and corporate training for all direct reports.- Assists Senior Director with departmental resourcing and budgeting activities.- Communicates corporate decisions in a timely and effective manner through various venues to ensure staff are aware of updates to corporate culture, vision and management.- Participates in CRO partnership governance and alliance management activities as assigned, within and across programs and portfolios.- Represents Clinical Management interests in corporate and cross-affiliate initiatives, as assigned.- Leads and/or contributes to assigned departmental, CRO partner, and corporate standardization and continuous improvement efforts for issues relating to study design and execution.- Supervises contractors, as assigned.- Other duties, as assigned.
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Position Summary:Acts as the portfolio lead, supervising leadership in program development and clinical research within a therapeutic area. Acts as scientific lead for clinical program development activities within a product group or within a portfolio. Determines portfolio level standards for clinical operations, clinical development planning, scientific document content, data analysis and reporting, and reporting to senior management, OPCJ and affiliates. Ensures that scientific content of development plans and protocols meets requirements for simultaneous regulatory submission and optimal market access. Supports Medical Affairs and other functional areas in reporting program activities and results. Serves as a “resident expert” within OPDC for issues related to clinical operations, clinical development planning, program management, and internal reporting. Serves as a member of the Clinical Management Leadership Team. Key Job Responsibilities:· Sets performance expectations for each direct report. Determines portfolio level performance goals. Establishes a feedback loop among employee’s peers (on departmental and project teams). Provides specific and frequent feedback to the employee on his/her performance. Creates individual development plans.· Responsible for training and orienting new employee on corporate culture, corporate expectations and departmental/organizational policies and procedures. Works with various groups to devise training program(s) for the employee and makes arrangements for such sessions to be conducted. Ensures the employee has access to all required material, systems to satisfy their individual job responsibilities.· Communicates corporate decisions in a timely and effective manner through various venues to ensure staff are aware of updates to corporate culture, vision and management.· Provides scientific clinical research and operational expertise in the development of overall strategy and objectives of the GCDP, including performing/overseeing and providing background research (literature, SBA, competitive intelligence, regulatory guidance etc).· Directs development of current program level training materials, program slide updates for management, and program level template. Provide/support program level presentations & training.· Ensures program specific standards (e.g., CRFs, outsourcing specifications, slides, training) are developed and applied across all trials to ensure consistency of clinical dossier. · In collaboration with the protocol team, leads the clinical trial data ongoing medical/scientific review focusing on data integrity, trending & consistency across the program. Contributes to final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.· Serves as support for global affiliates in relation to regulatory filings, trial implementation, training etc.· Develops and presents long-term program level financial estimates (MLTE) as part of overall program strategy. Provides advice to senior management for budget adjustments across programs, portfolio, or OPDC, as requested.· Leads program level teams as Co-Chair and/or serves as lead clinical management representative for CRT/GBT/PDC/JDC/Alliance teams.· Contributes to the preparation and defense of clinical program documents (investigator brochure/IMPD, IND/CTA annual reports, Health Authority briefing books and submissions (NDA, MA, NDS etc.), including ongoing maintenance of filings and support of labeling teams. Leads development of clinical sections of regulatory documents (i.e. Investigators’ Brochures, briefing books, submission dossier, and responses to Health Authorities questions) and inspection readiness programs, where appropriate.· Develops strong scientific partnership with key advisors in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Leads program-related advisory boards/committees and meetings. · Supports the design & implementation of a program level HEOR strategy, including endpoint development where necessary.· Coordinates and/or supports program level inspection readiness strategies in preparation for and defense of global regulatory filings and ongoing marketed products.· Serves as contact for Medical Affairs/PBS related to medical information requests, public disclosure of information (e.g., clinicaltrials.gov) and publications strategies. Provides program training and interactions with MSLs, as appropriate.· Represents assigned programs to senior management and OPCJ, and disseminate information and tasks to team members.· Participates in CRO partnership governance and alliance management activities as assigned, within and across programs and portfolios.· Assists Senior Director with departmental resourcing activities.· Gives direction, training, and support to Clinical Management personnel within portfolio/compound team. Assists supervisors in skill set development activities.· Leads assigned departmental, CRO partner, and corporate standardization and continuous improvement efforts for issues relating to program design and execution.· Analyzes best scientific conduct and planning practices across products and portfolios. Designs and implements plans to incorporate practices· Researches and investigates industry best practices in the areas of clinical operations, clinical developmentplanning, and endpoint design/validation/reporting. Shares OPDC best practices in industry-wide forums.· Serves as a PORT reviewer for protocols within and across portfolios.- The ideal candidate will have a significant experience in implementing and overseeing Risk-based Monitoring approach and experience in central data monitoring and implementing novel technical solutions in clinical trials. In addition, a proven record of leading strategic clinical CRO partnerships and/or alliance management experience is highly desirable
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The Commercial Lead is a proven marketing and sales professional who is responsible for successfully delivering a differentiated commercial strategy for a Software as a Medical Device (SaMD) Digital Therapeutics product in Major Depressive Disorder. - Serve as commercial lead for digital therapeutic product, leading in the area of marketing, market access and sales strategy- Work closely with market access and sales organization to develop the annual commercial strategy, tactics and resources necessary to achieve strategic goals- Gain alignment from cross-functional and Otsuka leadership on strategy and action plans- Oversee and manage the commercial program budgeting and forecasting- Provide a comprehensive written strategic plan for SaMD product launch/go-to-market activities (e.g., customer target segments, key initiatives, KPIs, etc)- Implement and manage key initiatives/tactics for marketing for US- Work with outside agencies and other external vendors to jointly scope, manage and deliver initiatives/campaigns when appropriate- Provide leadership, direction and management of the market research and business analysis functions for this new product.- Assure that all marketing collateral and related items are in compliance with medical device regulations- Provide leadership and/or support the digital therapeutic design requirements (e.g., voice of the customer/market requirements) as well as the implementation for the specific product- Identifying a payer path to market and securing profitable reimbursement- Identifying where product is optimally suited in the treatment algorithm and for various specialist providers, e.g., psychiatrists, PCPs, psychologists- Prepare presentations regarding current and future commercial strategy in digital therapeutics.Contribute to the developing company digital strategy/vision and translate it into broad strategies and tactics
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Provides customized information strategies, solutions, and services for internal clients globally to support business decisions in clinical development and commercialization. Manages global online information portals and systems, including assessment, licensing, deployment, vendor relationships, administration, and usage monitoring. Manages key stakeholder engagement and promotion of online resources and information services. Develops and manages global user training programs. Supervises Princeton-based team. Serves as project manager for global projects. Leads administration and development of department SharePoint intranet site. Evaluates and deploys new information management, organization, and search technologies.- Provides customized information strategies, solutions, and services for internal clients in the U.S., Europe, and Japan, to support business decisions in clinical development and commercialization. Works with clients to translate information needs into effective search strategies, uses specialized resources to locate information then evaluates, analyzes, and delivers quality research results.- Manages global online information portals and systems, including assessment, licensing, deployment, vendor relationships, administration, and usage monitoring- Manages key stakeholder engagement and promotion of online resources and information services, through individual and group meetings and marketing efforts across multiple channels.- Develops and manages global user training programs, including identifying needs, coordinating with vendors, and implementing processes for measuring effectiveness.- Supervises Princeton-based IRC staff.- Serves as project manager for global projects.- Leads administration and development of department SharePoint intranet site, including needs analysis, content updates, interface enhancement and upgrade deployments, and usage tracking.- Evaluates and deploys new information management, organization, and search technologies.- Supports tracking and monitoring of products and industry trends to provide competitive and business intelligence to help business enhance strategic planning.Travel (approximately 5%)
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To be a credible source of evidence based information that demonstrates the value of Otsuka products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers and other key stakeholders to apply practical real-world solutions to improve patient outcomes. Key Job Responsibilities:- Ensure appropriate dissemination of clinical information, knowledge and services in a timely, ethical, and customer-focused manner.- Keep abreast of the current literature, therapeutic issues, and competitive landscape related to psychiatric disorders.- Establish status as a knowledgeable and trustworthy medical and scientific resource for opinion leaders with expertise and knowledge of supported product(s), treatment trends, clinical trials, and scientific research.- Communicate current and emerging clinical research data to opinion leaders in response to unsolicited inquiries.- Identify medical experts to provide services as speakers, consultants, and investigators.- Engage national, regional and local payers, payer advisors and influencers that make patient access and reimbursement decisions.- Communicate cost effectiveness evidence that address payer needs and priorities; partner with providers and payers to put into practice decision support and care management tools and apply real-world evidence and solutions in the practice setting.- Deliver scientifically focused balanced and objective educational presentations to groups of strategic importance such as hospital and payer P&T committees.- Train speakers for promotional programs on product knowledge, clinical/scientific data, and information consistent with established company policies and compliance guidelines.- Participate and interact with opinion leaders, local practice leaders and other key stakeholders, including preparing moderators at national, regional and local conferences, advisory boards and other approved gatherings.- Gather scientific and competitive intelligence as well as customer insights during interactions with opinion and practice leaders or attendance of congresses and communicate to relevant Medical Affairs and Clinical Development personal.- Evaluate and assess potential investigational sites for participation in Otsuka-sponsored clinical studies as well as educate investigators about the study drug and pharmacovigilance procedures.
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Otsuka is looking for candidates with expertise in machine learning, artificial intelligence, statistical data analytics, and applications. The prospective candidate must have an excellent knowledge of advanced methods, and experience in applying those methods to a variety of applications. The successful candidate will be energetic, open to grow in new directions, work with a team of scientists and practitioners from different functional areas to solve problems in pharmaceuticals.- Establish and implement end to end proof of concept for data analyses across functional areas- Create innovative methodologies for data- Build proof of concept systems- Establish strategic partnerships with technical leadership across functional areas- Presenting to senior leadership as well external audience- Demonstrates the ability to create new and different solutions that align to real work problems and opportunities- Proficiency in computer programming with excellent software development skills using state-of-the-art technologies and languages (C++, Java, R, Python, and other scripting languages)
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We are a company that believes in performance excellence, which is based on a framework of Performance, Leadership, and Continuous Improvement. We will accelerate our sales growth through the leadership and development of our people to outperform the competition. Position Summary:The Renal Account Manager contributes to OAPI’s overall sales objective by performing assigned sales related activities. Provides hospitals, physicians, pharmacists and healthcare providers with products, services, and information that will enable them to use and prescribe OAPI products safely and effectively.We are looking for individuals who are highly motivated, learning agile, and can grow in a Commercial organization.Otsuka-people who:- Think differently by challenging conventional thinking- Are intellectually curious and life-long learners- Are effective, ’get it done’ and have a sense of ownership- Are comfortable with ambiguity, autonomy and recognize that innovation is at its best when people connect- Are remarkable in their chosen fieldKey Job Expectations/Responsibilities:- Ensures full compliance with drug laws, regulations, and OAPI policies in all aspects of interactions with healthcare professionals- Achieves the assigned sales objective for the territoryEffectively manages the formulary process to ensure product acceptance to assigned hospital accounts by establishing credibility with key hospital stakeholders, performing timely formulary review for products, expediting formulary acceptance of product, implementing effective plans for product pull-through, and organizing in-services to communicate appropriate approved product information to appropriate hospital personnel on all shifts- Attains the designated goals for calls on appropriate accounts and healthcare professionals- Communicates balanced, accurate, and complete information on OAPI products- Executes calls on pharmacists in order to provide product information and to ensure the availability of OAPI products in assigned accounts within the territory- Collaborates with market access team for formularies and product availability- Demonstrates consistent completion of all administrative requirements in a timely manner, including call reporting, budget management, log-ins, etc.- Completes all required training courses and continually updates product knowledge- Assists district manager in training new Renal l account managersCompliance Management:- Ensures full and complete compliance of all selling activities within the area of responsibility to OAPI standards and to all state and federal regulations- Complies with the letter and spirit of all state and federal laws, regulations, and guidance as well as PhRMA Code on Interactions with Healthcare Professionals and OAPI standards and policies relating to all promotional activities
