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This position will be responsible for supporting the trade operational functions within the market access department. • Manage the Trade & Specialty Pharmacy Operations for the portfolio of OAPI products• Manage Patient/Physician Support Services via Specialty Pharmacies• Maximum value from performance contracts through score carding and internal coordinationThe position will report to Senior Director of Trade and Specialty Operations.• Day to Day interactions with each of the SP’s including managing ad-hoc customer inquiries/request on issue resolution• Managing the SP network and individual SP performance via scorecards• Conducting Qtr. Business Reviews with each of the SP’s• Manage all touchpoint with internal and external parties including request from the sales force and Assure.• Create and manage various trade/SP agreements and communications to support the portfolio of products• Implement and manage trade customer contracts, by analyzing and monitoring data in order to maintain optimal inventory levels. Identify appropriate metrics and tracking to ensure the right execution and success; analyze procedure volume, trends, growth, for the wholesale/retail channel.• Support internal trade reporting for Market Access by analyzing data from weekly trade reports, monthly management reports, Lost Sales, and others as identified • Collaborate with pricing, contracting and compliance to ensure all wholesaler/specialty contracts and fee for service agreements are compliant with government regulations. • Develop relationship with key personnel within the trade/retail organization to help drive sales, reduce cost and help with launching of new products• Contribute to development of product and channel specific contract strategies• Manage all aspects of the business: tracking the supply chain, managing contracts, developing processes and procedures, and developing reports for internal and external stakeholders• Develop distribution and customer service related policies and procedures including but not limited to orders, returns, customer complaints, product launch, and brand security.
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The Neuroscience Training Manager (TM), is responsible for ongoing training programs to enhance the Neuroscience Account Manager’s ability to successfully perform his/her job. The TM will lead the development and delivery of training programs by collaborating with his/her training team members, Training Operations, marketing, sales teams and PRC team members. The TM will continually assess the training needs of the Account Managers to ensure it is aligned with business goals and maintains the high quality of the sales force. The TM will be involved in evaluating the effectiveness of training programs. • Works closely with Marketing and Sales to plan for and develop learning programs that support the marketing and sales strategies. Ensures alignment of learning programs with business goals.• Works closely with National Field Training Managers (NFTM) and Sales Leaders to ensure successful pull through of training programs.• Assumes role of primary Neuroscience trainer: Trains Neuroscience Account Managers: product knowledge, marketplace competition, effective communication, basic to advanced selling and negotiation skills, business acumen, administrative procedures, general medical terminology, managed care, and disease management. Assists with developing and implementing strategic training plans for new product launches. Supports the NFTM in creation of strategic brand pull through training. Assists in the design, development, and implementation of the Account Manager training programs in a variety of formats.• Conducts all Training programs and TTT for National/POA training sessions. Facilitates and evaluates role plays in various selling situations.• Works with co-promotion partner(s) to develop mutually beneficial training programs.• Consults with Training Operations and outside vendors in training material development• Works with and evaluates outside vendors. • Assesses the training and developmental needs of Account Managers through various methods, including field visits.• Evaluates the effectiveness of the training and takes appropriate steps to continuously enhance the quality of the training curriculum.
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Co-located with the European BD team, this individual will report into the Sr. Vice President, Business Development US. This role has been created to provide leadership to the scouting of new clinical stage opportunities in Europe to support the Global BD effort at Otsuka, and to add essential capacity in Europe for scouting activities. The Dir. Business Development must possess substantial and extensive scientific knowledge and experience working with compounds and development. In addition, the role requires extensive experience in the pharmaceutical industry, including a broad and deep understanding of development, regulatory and commercial. This individual will lead the process for identifying, screening and prioritizing and of scouting projects within clinical stage business development. Ensure initiatives are in alignment with corporate strategy objectives. In collaboration with the European BD team, acts as a communication conduit for scouting activities. Key Responsibilities: • Lead search and evaluation effort in the field to proactively identify and solicit new strategic research partnerships with biotech and pharmaceutical companies, academic institutions, non-profit research or patient organizations • Work closely with relevant internal R&D teams to deeply understand their scientific strategy and align outreach strategy with existing and new areas of Otsuka’s R&D focus to align on opportunity assessment• Work with strategic partner on business development activities this includes support on full implementation of business services, follow up support, and identify business expansion opportunities• Attending key conferences across Europe and further developing the European network with an intention.• Working closely with the Europe based BD team and Otsuka country teams to leverage existing Otsuka relationships in the scouting space• Maintains a therapeutic understanding and competence in area of focus to understand business, science and operations to lead to viable opportunities.• Perform initial scientific evaluation of external opportunities across all stages of developmentKnowledge:• Business development experience specifically within early clinical stage business development• Requires demonstrated knowledge and understanding of pharmaceutical development and commercialization and business practices required to successfully bring drugs to market and launch drug product• Strong local network across European countries• Knowledge of regulated environments including a basic understanding of payer and provider systems in US, Japan and G5 markets• In-depth knowledge of enterprise portfolio management and strategy• Extensive scientific knowledge Skills:• Self-starter who is able to effectively lead multiple projects simultaneously • Deliver and produce outcomes consistently over time• Strong negotiator and collaborator who strengthens business relationships• Effective creator and presenter of executive and functional information• Strong business acumen and analytic and quantitative skills • Utilizes experience, presentation and influencing skills to facilitate successful acquisition of the right opportunities • Demonstrates team and resource management skills; including the ability to manage team dynamics across companies.• Ability to influence and lead cross-functional teams Competencies:• Consistently demonstrates competencies at the Senior Leader level: Strategic Agility, Learning Agility, Building Effective Teams, Developing Directs/ Others, Decision Quality, Dealing with Ambiguity, Managerial Courage, Managing Vision/Purpose
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The ROM will work closely with Regional Sales Directors and will be responsible for providing support on strategic initiatives across the sales organization. Responsible for facilitating execution of sales operations and field force effectiveness processes and activities to address operations needs within respective geographical areas. Responsible for gathering and analyzing data, making recommendations, and running reports as it relates to increasing operational effectiveness within their region. The role will contribute to OAPI’s overall sales objective by performing assigned sales related activities and supporting the efforts of the Regional Sales Directors’ focus on core activities with a direct line of sight to the development and performance success of the field sales force. It is expected that the successful incumbent in this role will develop skills and experiences needed to advance to roles of greater strategic importance to the business. The Regional Operations Manager is considered skilled or advanced in their demonstration of sales and leadership proficiencies. This Individual Contributor is fully self-sufficient and able to apply skills successfully in all situations. Specifically the ROM will:- Competitive Landscape and Sales Strategy - Ability to devise strategies and plans (e.g., sales, operations, training) based on an understanding of the competitive landscape and Otsuka’s competitive position in the marketplace. - Business Management - Ability to plan, allocate, monitor, organize, and prioritize activities and resources to maximize sales performance and measure progress against plan.- Critical Thinking - Ability to understand a situation, issue, or problem by breaking it into smaller components. Ability to collect information, derive inferences, find solutions and make informed decisions and recommendations using data and tools where appropriate.- Pharmaceutical Environment - Ability to apply knowledge of pharmaceutical and regulatory environment, including Otsuka policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices. - Therapeutic Area Knowledge - Ability to apply therapeutic area knowledge to the sale of Otsuka’s products and/or to increase effectiveness in role.- Customer Development - Build and maintain internal and external relationships (e.g. customers, account contacts, stakeholders in Home Office, etc) based on customer needs and organizational politics.- Selling - Understand the core selling process, adapt style, and effectively negotiate to bring value to the customer and close the sale.- Vendor Management – Knowledge of available resourcing options. Understands when and how to use external resources. Knowledge and experience in selecting vendors, working with vendors, and managing the performance of allocated resources according to contractual expectations.Key Responsibilities:- Monitors and follows up on region operating issues and activities, e.g. ad hoc requests from home office and field, etc.- Assists RSD in development, communication and implementation of region business plans.- Gathers and processes data related to, but not limited to, sales performance, productivity, incentive compensation, managed care, and promotional programs.- Assists RSD with tracking and monitoring region and district performance and execution by analyzing results and identifying trends, bringing recommendations and solutions as appropriate.- Tracks the allocation and utilization of resources, e.g. speakers, programs, sales education presentation (SEP) funds,, and regional operations budget, and monitors adherence to Otsuka policies and procedures.- Communicates and collaborates with key internal and external stakeholders regarding sales operations and execution Executes approved tactics and initiatives addressing regional business opportunities including payer pull through.- Coordinates the planning and execution of regional meetings and teleconferences.- Engages the home office team and DMs in the development and facilitation of workshops.- Coaches Account managers directly; provides feedback to develop and maximize skill sets and core behaviors.- Serves as a liaison between OAPI functional areas to research and resolve operational issues.- Provides high level communication with alliance partners and ensure our processes are consistent.- Ability to create and deliver standard and ad hoc reports and correspondence as identified by the ROM and directed by Regional Sales Directors.- Demonstrate excellent written and oral communication skills – able to provide compelling and effective communication across all levels of the organization.Compliance Management: - Must comply with all state and federal laws, regulations and guidelines including PhRMA Code on Interactions with Healthcare Professionals as well as complying with all OAPI standards and policies relating to all job activities
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Working closely with supervisor or other members of the department, the Associate Program Manager (APM) supports the Clinical Program Management team, in establishing and tracking project scope, timelines, activities, and budgets. The APM serves as a liaison to support program management communications to team members. Working proactively with manager or other members of the department, the APM provides input to identify and resolve issues in a timely manner so as to meet project objectives. The APM is committed to maintaining a positive, results-oriented work environment, building partnerships, modeling teamwork, and communicating in an open, balanced and objective manner.- Under the direction of manager, responsible for supporting departmental and corporate initiatives to drive process improvements.- Provides professional program management support Manages project information for assigned projects and is responsible for developing and maintaining good relationships with other functions such that it will foster positive interactions and ultimately support achieving desired project outcomes.- Maintains project timelines and prepares routine status reports ensuring timely and accurate project information is available- Responsible for maintenance of the project actions, decisions and issues (ADI) log for project team interactions.- Supports the project teams toward implementation of the strategic and operational plans and tracks progress to goals. - Assists manager or other senior member of the department to implement the Global Development Commercialization Plan (GDCP) for their project, driving to the next action point, decision point development/analysis, and associated analytics- Manages and tracks program progress as assigned on a continual basis, identifying and tracking both cross-project and cross-functional issues, scope issues at project and program level, timeline issues, and budget issues. Works proactively with manager and the project team to achieve timely resolution of these issues in order to achieve approved program objectives. These activities include those that are outsourced. Travel (approximately 20%)
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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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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. Serves as a member of the Clinical Management Leadership Team. - 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.- 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.- Serves as a PORT reviewer for protocols within and across portfolios.- 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.- If supervising employees, 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.
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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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The Otsuka Talent & Leadership Consulting team aims to develop a rare and engaging culture made of unconventional talent. We believe a culture that defies convention will enable the business to leap forward past competitors while providing value to our patients and customers. The Talent & Leadership Consulting team serves as internal consultants that aim to challenge traditional ways of recruiting, managing performance, and developing employees with fresh new approaches.The Sr. Talent Partner will lead employee leadership development consulting services. Just like our ever changing business environment, this role is not static and the Sr. Talent Partner will exercise agility and contribute to other areas of our HR strategy as needed. In addition, the Sr. Talent Partner will be expected to share his or her perspective, ideas, and creative recommendations that address new opportunities and gaps. This role is an important contributor to the implementation of talent and leadership development strategy and is encouraged to define new ways of contributing value to the team and Otsuka.Key Job Responsibilities:- Design , implement, and embed a consulting suite of leadership development solutions for the organization that are non-traditional and impactful- Be an ambassador of the Otsuka culture- Consult internal business clients to determine appropriate talent solutions - leadership development, team effectiveness, and Otsuka development related opportunities- Be “in the know” with the latest research and trends that could inform Otsuka development and talent strategy (e.g. external resource gathering, networking with thought leaders, etc.)- Roll up sleeves and manage execution of development initiatives with a focus on outcomes- Manage vendor relationships and internal stakeholder participation in the design of talent initiatives- Partner with talent team colleagues to deliver impactful development solutions to the organizationUnconventional Thinking:- Willing to un-learn entrenched ways of doing things and is coachable- Thinks strategically; intuitively makes connections and associations- Has an eye for detail and design- Strong interest in working in a rapid and entrepreneurial environment Execution & Outcomes:- Strong action orientation – able to execute on ideas and execute against clear plans with autonomy- Skilled in adult learning principles and instructional design- Great organizational instincts and observant of culture dynamics- Communicates effectively; engaging workshop facilitator- Stellar presentation skills (e.g. powerpoint communication)- Analytical and comfortable using data and technologyAgility:- Ability to adapt and learn on the fly (learning agility)- Deals with ambiguity and is able to change directions when neededDiversity of Thought:- Humility- Is motivated when working with others- Great amount of EQ and interpersonal savvy
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The Clinical Data Scientist at Otsuka will support a diverse array of initiatives including advanced computational modeling, clinical development (with particular focus on digital programs), and software development projects. Paramount to this role is the ability to support clinical programs with appropriate analytical strategies.- Work closely with stakeholders interfacing with clinical and real-world data to identify, enhance, and support the quantitative and technological needs for all Otsuka projects- Managing software development projects at various levels- Reviewing/planning clinical studies across multiple CNS programs, and conducting analyses related to time series modeling, supervised and unsupervised learning techniques, Bayesian methodologies, and others- Provide statistical and modeling support for planning and implementing clinical and real-world evidence studies/programs to meet the value/evidence needs of payers, health systems, clinicians, and patients.- Provide solutions of clinical and economic utility by leveraging internal, external and real-world data sources. - Guide evidence-based product development (digital/non-digital) by extracting therapeutic intelligence from such data sourcesTravel (up to 15-20%)
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The IOS Security Operations Associate Director is instrumental in managing the effectiveness of the security operations practice, including, but not limited to: monitoring, detection and mitigation of cybersecurity threats, vulnerability and threat management activities, and incident handling/triaging practices at Otsuka America Pharmaceutical, INC (OAPI). This individual should have a deep understanding of operational cybersecurity coupled with extensive hands on experience to defend against ever increasing and more sophisticated cybersecurity threats. This individual also is key to Otsuka’s security incident response and associated communications including coordination with the Information Security Officer, the CSIRT and other key stakeholders. Vendor management and security team coaching and development are other key aspects of this position.Responsibilities:• Establish processes to monitor, analyze, and report output from security monitoring systems.• Coordinate and liaise with others to take necessary corrective action.• Monitor stakeholders’ completion of compliance and risk management processes and deliverables.• Implement operational security standards, processes, procedures, and guidelines.• Work with other IT teams, users, and vendors on security solutions and implementation.• Develop and conduct preparedness tests to demonstrate operational efficiencies.• Set-up procedures and automated processes to monitor the status of computers and the network.• Respond immediately to any detection of unusual patterns of behavior and possible threats.• Analyze metrics to identify any trends that might indicate patterns of future risks.• Provide regular reports and metrics for management on the company’s IT security status such as KPI’s, incident tracking reports, proposals for improvements, as well as tactical and strategic planning initiatives.• Remain current with the latest cyber security technologies and threats.• Document and communicate to all stakeholders and senior management on all cyber security related items such as incident management, problem detection, situation management, and service recovery.• Manage security vendor relationships and ensure adequate actionable performance.• Provide input and evaluation on security aspects of non-security related technology, e.g. software applications and tools, hardware, services, etc.• Constant monitoring of company IT and data assets to ensure security controls are operating and functioning as intended.
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The Sr. Manager US Medical Affairs – Renal supports Director Medical Affairs to provide Medical Affairs support for OAPI’s US Renal franchise.Renal Product Commercialization and Development - Serves as member of brand team for Otsuka Renal products. - Provides medical input to all aspects of product development and promotion across the entire product lifecycle.- Support the execution of medical affairs strategic plan for Otsuka products- Review medical content of promotional materials for accuracy as part of promotional review committee - Identify and develop relationships with external consultants, KOLs, investigators and vendors- Participate in extramural conferences and scientific meetings to maintain awareness of research in the field.- Applies strategic intent of OAPI when working with FDA, opinion leaders, prescribers and consumers of OAPI products- Manage and execute publication plan for Otsuka products as needed- Manage Investigator Sponsored Trials as neededIn-house Customer Support- Provide content resources to Field Medical Affairs consistent to Medical Affairs strategy - Coordinate with sales management to provide training to sales staff.- Keep abreast of current state-of-the-art developments relating to in-house medical program focus, and provide education to clinical staff and other project team members, as needed.- Serve as a source of medical expertise on Otsuka clinical trials for in-house customersMedical Information and Grants Support- Provide direction for medical information specialists. - Provide technical assistance to medical information specialists.- Review grant requests as neededTravel (approximately 20%)
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Responsible for ensuring the satisfaction of Global Pharmacovigilance (GPV) organization needs for safety systems. Provide technical and managerial leadership to a global team of technical staff ensuring close interaction with the end-user community with the objective of delivering high quality, compliant, validated and timely solutions.Job duties include:Responsible for maintaining data and system configurations for safety systems in accordance with Otsuka methodologies, applying knowledge of technology, regulations, policies, processes and/or procedures to control and maintain accurate records.• Responsible for maintaining the validated state of systems by overseeing validation tasks across the GSDM team and in close interaction with Otsuka Global Quality Systems teams.• Work closely with all GPV functional areas to develop solutions, work plans and oversee their implementation, including but not limited to gathering, business requests for safety systems, changes and upgrades. Provide subject matter expertise for safety system upgrades and changes.• Manage system incidents, changes and problems by application of Otsuka and industry best practices. • Provide accurate timely reports on the status of incidents, changes, problems and assigned projects. • Responsible for managing offshore support team and coordinating their daily activities.• Responsible for producing weekly performance metrics quantifying the support work.• Assist in defining, designing, developing, testing and deploying systems.• Ensure timely and appropriate escalation of risk, issues and concerns to the GSDM leadership.• Responsible for conducting E2B pilots with Regulatory Agencies and partners.• Support GPV Business intelligence in the development, validation and management of necessary line-listings, aggregate summaries, data exports or customized reports from safety data sources.• Provide/support user training on safety systems.• Perform other tasks as assigned.
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The Senior Manager, Forecasting role within the Business Analytics & Insights organization at Otsuka is responsible for developing and managing rigorous commercial forecasts for all Otsuka assets. Scope of responsibility includes forecasts for early development assets, pre-launch assets, inline assets, business development opportunities and life-cycle opportunities. Moreover, forecasting oversight spans across all disease areas of company interest, including Central Nervous System (CNS) disorders, Renal disease, Oncology, and Digital Medicine. The Senior Manager, Forecasting role reports directly to the Director of Forecasting as part of the Business Analytics & Insights organization. Key stakeholders include senior management, brand leads, business development/early development leads, cross-functional partners (brand analytics, finance, trade, market access, supply chain, etc.), as well as current/potential partner companies.Key Functions:• Lead/support revenue forecasting for US assets, including early development assets, pre-launch assets, inline assets, business development opportunities, life-cycle opportunities, mid/long term planning and portfolio review processes.• Lead/support the development of comprehensive, transparent, and standardized forecasting models that meet the business needs and are informed by the most appropriate approach (e.g., historic time-series models, patient models, Rx models and other forecast methodologies).• Ensure that forecasts are robust and credible by fully leveraging available secondary data, primary market research data and competitive intelligence data.• Lead collaboration with key stakeholders and cross-functional teams to review forecast assumptions, ensure consistency, transparency, and robustness of all inputs and outputs.• Clearly communicate the revenue forecast and associated range to key stakeholders. Proactively identify potential risks and opportunities to inform strategic and tactical business decisions.• Lead analytic team members, contractors, and external agencies to increase & enhance the use of advanced modeling and analytics to improve continually the quality of forecast models and results.• Identify and evaluate proactively relevant data sources, analytical tools, or industry best practices that will enhance customer, market and competitive understanding to inform forecasting work.
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Provides regulatory strategy, planning and execution of investigational and marketed prescription drug submissions and lifecycle, working closely with cross-functional areas of the company. Applies regulatory intelligence and expertise to effect innovative regulatory pathways and solutions to complex global requirements.Responsibilities- Develops the global regulatory strategy for all assigned R&D and marketed project(s) as the Global Regulatory Lead or in conjunction with the Global Regulatory Lead and subteam (regional leads, CMC-RA, labeling, medical writing, regulatory operations).- Authors, coordinates, reviews, and executes increasingly complex submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines.- Interacts and manages internal/external functional business units effectively to gather data and develop documentation required for on-time submissions.- Ensures submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities.- Determines innovative and sound strategies in support of submission goals. Able to provide multiple options to address regulatory challenges and opportunities - Represents RA with regulatory guidance/strategy/perspective in project team meetings and intermittently at senior leadership governance meetings as needed.- Translates and presents pertinent evolving regulatory requirements to Global Regulatory teams and to internal/external functional business units as needed. - Works closely with the Global Regulatory department to execute departmental initiatives to improve overall efficiency, quality, and/or output.- Provide creative and innovative ideas to move the Global Regulatory department to address current and future challenges
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Think Team works on building academic and industry collaborations with a primary goal to drive innovation at Otsuka. The team comprises of a group of research scientists, postdocs, and data scientists focusing both on scientific and technology innovations in healthcare. The data scientist will support translational research and/or technology development for drug discovery and clinical development, clinical trial operational efficiencies, digital assessments and health products, and other intelligent scientific/innovation information management tools. Responsibilities:- Support translational research in the CNS and oncology disease areas on the identification of prognostic and predictive digital/molecular/imaging biomarkers, characterization of disease and its progression, and identifying/development of new assays towards diagnostics/algorithms that enable personalized/precision medicine by guiding targeted, individualized use of therapies to the patients that will benefit the most.- Develop innovative AI/machine learning/NLP/Signal Processing/Logic/statistics and mathematical modeling methods to provide therapeutic insights by leveraging internal, external and real world data sources. Experienced in graphical modeling (Bayesian networks, Hidden Markov modeling) and/or deep learning.- Guide evidence based product development by extracting market intelligence from such real-world data sources through knowledge representation and pattern recognition.
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- The Product Manager, Digital Medicine will support the Director of Product management in efforts to define overall product strategy for the Digital Platform portfolio, provide detailed product requirements, manage the product life cycle and evolution of the various products within the portfolio, and provide guidance to internal product development teams for work prioritization.- Support Product Director for overall program management and working cross functionally across other internal development stakeholders on communicating product direction and priorities.- Assist in market surveillance and management of product lifecycle.- Assist in providing content and assure compliance for continuous improvement with product support- Coordinate with software development team to ensure documentation is up to date alongside of development in a timely manner.- Provides input in preparation and management of HF testing.- Identify new product opportunities/ gaps and update product/feature requests.- Conduct training sessions as SME for internal stakeholders inclusive of field based staff (i.e. MML, etc.)- Participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality.- Other duties and responsibilities as assigned.
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Reporting to the Associate Director of Device & Drug Delivery Technologies, the Sr. Manager – Device Development is a technical expert who is responsible for managing the development of OPDC’s combination products, drug delivery device related projects following the requirements of OPDC, US and International Requirements as applicable. The Sr. Manager will be responsible for the creation and management of design history files and technical dossiers for combination and device projects for new and existing products. Additional responsibilities include creation and management of product and component specifications, design control documents, engineering protocols and reports and frequent presentations to project teams and management. The Sr. Manager will also be responsible for evaluating, developing, and implementing new and innovative device/delivery technologies, and maintaining expertise in state-of-the-art technologies available in industry and academia. This position will frequently require management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization. The Sr. Manager is a technical expert in the field of combination products & drug delivery devices who can effectively navigate, influence and balance complex engineering, regulatory, quality and commercial needs while developing the best product for the user and patient. Primary expertise should be demonstrated in engineering, device regulatory, device quality systems (cfr 820, ISO 13485), human factors engineering principals, risk management for medical devices (ISO 14971), etc. The Sr. Manager should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences. This position requires 8-12 years of applicable experience in the pharmaceutical, biotechnology or medical device industries. Support the vision for the Device Technology function- Support and implement a vision with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs- Work with the Associate Director Device Technology, and other functions including Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, and Quality Management to support strategies for product and process improvements- Support the development of flexible and compliant product development process. Develop and support the strategic activities of the department:- Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration of all new products and life-cycle management products.- Initiate and manage the development and implementation of policies, procedures, and standards for the Device Technology department.- Evaluate and recommend strategic directions for new and innovative delivery device technologies to support new and life-cycle management projects. Develop and perform the tactical activities:- Ensure efficient transfer of products and on-going product support all products to CMO’s from device perspective.- Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products.- Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work to develop device risk mitigation.- Create, maintain and update device related documents required for regulatory filings and complianceProgram management of Device projects:- Develop project plans and corresponding project managements tools to support the execution of all projects- Manage cross functional teams (including 3rd party resources)- Lead Human Factors Engineering & Usability activities
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Post-doctoral scientist/Research Fellow will support translational research and/or technology development for drug discovery and clinical development, clinical trial operational efficiencies, digital assessments and health products, and other intelligent scientific/innovation information management tools. This is a short-term position for approximately 1 year and can be extended for an additional term upon satisfactory progress.Additional Responsibilities:- Support translational research in the CNS and oncology disease areas on the identification of prognostic and predictive digital/molecular/imaging biomarkers, characterization of disease and its progression, and identifying/development of new assays towards diagnostics/algorithms that enable personalized/precision medicine by guiding targeted, individualized use of therapies to the patients that will benefit the most.- Develop innovative AI/machine learning/NLP/Signal Processing/Logic/statistics and mathematical modeling methods to provide therapeutic insights by leveraging internal, external and real world data sources. Experienced in graphical modeling (Bayesian networks, Hidden Markov modeling) and/or deep learning.- Guide evidence based product development by extracting market intelligence from such real-world data sources through knowledge representation and pattern recognition.
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Lead the Otsuka HCP Team and work collaboratively with our alliance partners to develop overall HCP strategic direction and tactical execution through personal promotion and professional medical education (PME) channels. Collaborate, align, and coordinate with sales leadership/field sales, multi-channel marketing, consumer marketing, cross-functional partners, medical, promotional compliance, legal, and external agencies to develop strategy, deliver key tactics on time and within budget, and develop and deliver a clear communication and implementation plan for all tactics. Manage a significant budget, determine appropriate tactical mix, and successfully pull through tactics in partnership with sales leadership. Partner with both Otsuka and global market to ensure the successful transition of life-cycle management activities into the US market. Manage, direct, and mentor two direct reports responsible for HCP personal promotion and promotional medical education. This position will report to the Brand Lead. Individual should have a proven track record that demonstrates the breadth and depth across marketing competencies and achievement of performance objectives. Strong leadership skills are necessary to lead/contribute to overall sales execution of key deliverables. Experience working with cross-functional teams; e.g., Sales, Training & Development, Business Analytics, and Legal/Medical/Promotional Compliance Review Committees (PRC), is required. Ability to work with a sense of urgency and manage ambiguity and lead through dynamic competing internal and external demands. ● Developing US HCP strategies aligned with brand strategic imperatives, and executing corresponding tactics that are impactful, compliant, and within budget○ Managing HCP creative Agency of Record (AoR) for strategic planning, tactical content development and deployment from conception to execution and evaluation○ Working closely with legal, medical, & regulatory partners to ensure all field-delivered promotional resources are reviewed and approved by the Promotional Review Committee (PRC), resulting in compliant and impactful deliverables○ Consistently monitoring project budgets, expenses, and timelines; demonstrating strategic focus and critical thinking ensuring optimal use of limited resources○ Working with Business Analytics partners (both primary and secondary research) to ensure pull-through of customer insights and market research findings to HCP strategy, messaging, and resources● Working closely with sales training and development on all salesforce related training materials for new marketing resources and for training content at POA meetings● Collaborating with sales and sales leadership in identifying needed selling resources, customer concerns, and competitive threats. Developing resources in conjunction with sales and ensuring a consistent feedback loop to gain opportunities for enhancements and to monitor effectiveness● Managing, directing, and mentoring two direct reports who will assist in all tactical level responsibilities associated with HCP promotionLeading in the development of annual brand strategic and tactical plans, and accountable for providing project updates to senior leadership committees
