Takeda

Manager

• The Rare Disease Business Manager (RDBM) is responsible for driving sales and territory growth through effective execution of sales strategies and tactics in a rare neurological sleep disorder, called narcolepsy type 1.
• This role involves collaboration with their Regional Business Leader and other cross-functional, customer-facing teams to ensure healthcare providers (HCPs) are well educated and that appropriate patients have access to a new therapeutic option, once approved by federal agencies.
• Establish and build impactful relationships with targeted HCPs and accounts within their geographic territory.
• Following regulatory approval, the RDBM will play a key role in generating demand for a new therapeutic option by focusing on educating and informing healthcare professionals.
• Drive sales by implementing sales and marketing plans, leveraging strong selling skills utilizing approved, on-label materials to achieve monthly, quarterly, and annual sales goals.
• Build strong relationships with, and educate healthcare professionals (HCPs) on disease state and approved Takeda orexin therapies.
• Strategically analyze local, regional, and national business trends and apply data to assess business opportunities and strategic priorities.
• Utilize CRM system to document account profiles, develop pre-call plans and record post-call activities.
• Manage a territory budget in a manner that is consistent with all Takeda compliance policies.
• Collaborate with internal teams to align on strategies and tactics that support customer and business outcomes.

Rare Disease Business Manager

• Define developing and delivery of the global site start up plan
• Oversee the analysis of clinical trial data and its application to conduct accurate study start up forecasts
• Drive rapid, accurate, and data-driven study start up forecasts
• Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Site Start Up Services
• Establish, develop, and deliver the Global Site Start Up Plan
• Partner with Clinical Operations teams, and TAU partners to improve overall site start up metrics and implement processes
• Provide guidance, oversight, and training to the Site Start Up team
• Ensure standards are applied to the study start up process across project portfolios
• Guide the collection and analysis of all data to influence site start up timelines
• Drive delivery of all Takeda and CRO supported sites that are 'Ready To Enroll'.

Manager, Site Start Up

• Conduct data-driven feasibility assessments for Phase I – IV clinical studies, including protocol design optimization, country/site feasibility and selection, enrollment strategy, and modeling.
• Use all competitive intelligence data to develop data-driven study start-up forecasts, benchmarking assumptions, and accurate enrollment plans.
• Contribute to implementing creative processes, methodologies, data and technologies to ensure ongoing delivery and continuing improvement of Feasibility and Enrollment Forecasting Services.
• Participate in and/or lead global projects representing CSS&E and GDO to support Takeda R&D goals.
• Develop feasibility analyses to maximize efficiency, effectiveness, and acceleration in Takeda's operational execution of its clinical research studies.
• Ensure standards are applied to the feasibility process across project portfolios and direct continuous improvement activities while developing TA-aligned strategies.
• Collect and analyze all data (e.g. local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, operational plans, and establish a geographic country footprint and proposed sites for participation in a clinical study.
• Leverage leading industry tools and data sources to provide data on startup timelines, past recruitment rates and performance (data quality, startup cycle time, query rate, protocol deviations, inspection results) to assist project teams with study initiation timeline forecasting.
• In partnership with internal stakeholders- combine and integrate data to provide clear feasibility recommendations to strengthen data-driven trend analysis, identify root causes, and provide relevant recommendations across study teams and programs to accelerate study execution.
• Monitor actual patient enrollment performance of assigned studies.
• In collaboration with the Takeda study team and CRO, responsible for re-forecasting patient enrollment models to adjust for new influence factors (e.g. change in drug landscape, protocol amendment, increased screen failure rate).
• Determine risk/ mitigation planning.
• Maintain current therapeutic area knowledge and assess impact of evolving information on operational strategies.
• Exhibit the ability to perform root cause analysis and determine mitigation steps to removing roadblocks related to study execution and patient enrollment.
• Ability to provide data-driven recommendations to assist with decision making at a study level as well as provide program level support to help define asset strategy.
• Through strong analytical skills, develop deep insights, uncover unmet needs, collaborate within a global matrixed team.
• Act as a role model for Takeda’s values.

Senior Manager, Feasibility

• The Rare Disease Business Manager (RDBM) is responsible for driving sales and territory growth through effective execution of sales strategies and tactics in a rare neurological sleep disorder, called narcolepsy type 1.
• This role involves collaboration with their Regional Business Leader and other cross-functional, customer-facing teams to ensure healthcare providers (HCPs) are well educated and that appropriate patients have access to a new therapeutic option, once approved by federal agencies.
• Reporting into a Regional Business Leader, the RDBM will support a new product introduction in a new therapeutic area for Takeda.
• Strong execution, insights gathering, and building our Company’s reputation will be critical to our success.
• The role will establish and build impactful relationships with targeted HCPs and accounts within their geographic territory.
• Following regulatory approval, the Rare Disease Business Manager will play a key role in generating demand for a new therapeutic option by focusing on educating and informing healthcare professionals by providing clinical information and in-depth knowledge of the product, the orexin system, and narcolepsy type 1.

• Drive sales and territory growth through effective execution of sales strategies and tactics in a rare neurological sleep disorder
• Collaborate with Regional Business Leader and other cross-functional teams to ensure healthcare providers (HCPs) are well educated
• Establish and build impactful relationships with targeted HCPs and accounts within the geographic territory
• Play a key role in generating demand for a new therapeutic option by educating and informing HCPs
• Analyze local, regional, and national business trends to assess business opportunities and strategic priorities

Software Engineer

• Work on EDC activities and oversee delivery of systems and documentation to support Takeda Clinical trials.
• Work with Takeda study teams to develop eCRF specifications, build and/or oversee implementation of Case Report Forms (eCRFs) for clinical trials.
• Manage and oversee EDC system configuration, dictionaries, and integrations.
• Accountable for the successful delivery, quality, and compliance of all EDC studies and study leads under their oversight.
• Provides mentorship and guidance to study leads, proactively manages risks, and leads escalation and resolution of complex issues to ensure study milestones are met.
• Operates in compliance with Takeda SOPs and processes while working with Data Management and Standards Teams to enhance existing processes.
• Understand Clinical Data Acquisition Standards Harmonization (CDASH) and Study Data Tabulation Model (SDTM) standards and concepts while considering EDC platform best practices.

Principal Electronic Data Capture Developer

Analyst

• Provide day-to-day support to end-users, identify system issues, and ensure the smooth response to HCM requests.
• Triage all support tickets to determine which should be handled by HCM support, which require systems changes, and which should be routed to another team for management.
• Collaborate with business stakeholders to understand their needs, analyze business processes, and document requirements for system enhancements and changes.
• Develop and execute test plans and cases to ensure the quality of system updates and new features.
• Complete data uploads to support mass changes required in the system.
• Build Workday reports, dashboards, and other analytical tools to provide insights into HR data.
• Create data audits to find data anomalies.
• Maintain system documentation, create user guides, and provide training to end-users.
• Ensure system security and compliance with data protection standards and other regulations.
• Identify process gaps and propose improvements to optimize Workday HCM.
• Measure timeliness and effectiveness of support ticket resolution and identify opportunities for improvement.
• Support Workday-related projects, including implementation, upgrades, and enhancements.

Workday HCM Functional Analyst

• System Support & Troubleshooting: Provide day-to-day support to end-users, identify system issues, and ensure the smooth response to HCM requests
• Triage all support tickets to determine which should be handled by HCM support, which require systems changes, and which should be routed to another team for management
• Business Requirements Analysis: Collaborate with business stakeholders to understand their needs, analyze business processes, and document requirements for system enhancements and changes
• Testing & Quality Assurance: Develop and execute test plans and cases to ensure the quality of system updates and new features
• Data Management, Reporting & Analytics: Complete data uploads to support mass changes required in the system
• Build Workday reports, dashboards, and other analytical tools to provide insights into HR data
• Create data audits to find data anomalies
• Documentation & Training: Maintain system documentation, create user guides, and provide training to end-users
• Security & Compliance: Ensure system security and compliance with data protection standards and other regulations
• Process Improvement: Identify process gaps and propose improvements to optimize Workday HCM
• Measure timeliness and effectiveness of support ticket resolution and identify opportunities for improvement
• Project Management: Support Workday-related projects, including implementation, upgrades, and enhancements

Compliance

• Direct and drive the implementation of compliance management related to quality events and internal audits for clinical trial delivery functions including the identification and development of applicable processes and tools
• Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA/EC-related compliance assessment
• Develop and report to leadership on key performance indicators and mitigation strategies for clinical trial delivery
• Oversee and manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting
• Facilitate clinical trial delivery internal audits with study teams and functional areas including but not limited to: study team preparation, facilitating audit requests, managing audit responses and CAPA development and implementation
• Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation.
• Lead clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical trial delivery procedures and developing effective mitigation and escalation strategies
• Proactively identify process/therapeutic area/project risks and develop/lead assessments to assess compliance
• Advise process owners and functional areas on the development and implementation of effective mitigation and escalation strategies for projects to address risks and issues
• Develop, lead and oversee compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence to the plan
• Engage and build relationships with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities
• Identify, develop, and track KPIs, metrics and dashboards to track process quality and compliance
• Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkers
• Act as role model for Takeda’s values

Associate Director, GCP Compliance

Account Manager

• Access to local formularies and/or protocols within own accounts
• In coordination with supply chain, ensure Takeda product(s) is/are available at account level
• Operate in a manner that is always in line with compliance and legal requirements and according to the marketing and sales strategies
• Act as an ambassador of the Takeda brand, its vision and values
• Develop long-term relationships between Takeda and key strategic accounts and their stakeholders
• Identify key external stakeholders and develop deep understanding of their needs, collaborating on initiatives and co-creating mutually beneficial solutions that will add value to them and the patients
• Drive the implementation of the innovative offerings with key stakeholders and help differentiate Takeda from its competitors
• Support and advise Healthcare professionals on the correct use of Takeda product and services portfolio
• Proactively coordinate collaboration with Marketing, medical and market access (and other internal stakeholders) to ensure alignment in objectives and activities with accounts and external stakeholders
• Monitor the account plan progress and hold collaborators, and self, accountable as agreed
• Lead the core account team meetings and present account plans and progress at relevant local meetings to the management
• Identify and address any collaboration misalignments
• Prioritize and manage accounts within assigned territory by assessing appropriate business opportunities through contacts with key decision-makers and important local stakeholders
• Systematically analyze success of plans (e.g. sales, market developments, competitors) and propose mitigating actions as needed.
• Use learnings to further improve planning and execution
• Make changes as needed based on new business opportunities and changes in the marketplace to achieve financial objectives

Business Account Manager, PDT, Private

• Management of HCP networks from a commercial perspective
• Building and supporting networks
• Analysis of patient pathways
• Implementation of project-specific activities with healthcare professionals

Network Manager, Gastrointestinal (GI)

Data Analyst

• The Data Analytics Manager plays a key role in supporting BioLife’s pricing strategy by combining strong analytical capability with business insight.
• Responsible for performing advanced data and financial analysis, translating trends into actionable recommendations, automating recurring processes, and supporting the development and optimization of pricing strategies that drive volume growth and improve cost efficiency.
• Partners closely with Operations, IT, and Data Science teams to execute pricing experiments, evaluate outcomes, and deliver timely, business-ready insights.
• Applies advanced analytics to diverse business scenarios, synthesizing complex information into clear, executive-ready insights and visualizations.
• Brings automation in day to day process to get quicker insights into business trends.
• Builds ML and statistical models to understand donor patterns and forecast cost metrics.
• Links analytical findings to business and donor behavior dynamics to explain drivers behind trends and performance shifts.
• Conducts rapid-turnaround analysis and delivers recommendations under tight timeframes.
• Builds and maintains forecasting models to project volume, cost-efficiency metrics, and donor behavior trends, enabling more accurate weekly and monthly planning.
• Supports the design, execution, and evaluation of experiments, including A/B tests, optimization pilots.

Manager, Data Analytics

Recruitment

• support the study teams in planning for and achieving enrollment
• develop patient recruitment and site engagement strategies
• lead study-specific recruitment programs
• conduct early operational planning and research
• proof and edit materials during development
• identify new potential vendors that offer creative solutions
• manage relationships with existing vendors
• help develop content such as presentations, articles, and newsletters
• support team programs and special projects
• help with miscellaneous administrative tasks

Manager, Patient Recruitment and Retention

• Oversee and provide quality patient engagement and recruitment services
• Execute patient recruitment deliverables supporting clinical project teams
• Manage contract and vendor relationship framework
• Evaluate and communicate financial impact of recruitment strategies
• Support Director with process improvement and mapping

Patient Recruitment and Retention Lead

• Project manage and facilitate cross-functional study execution teams’ GCP inspection readiness and inspection activities, including strategies to support process adherence, well-maintained TMF documentation and proactive study team preparedness for audits and inspections
• Manage cross-functionally to assure aligned approach to inspection readiness strategy with Clinical Quality Assurance (CQA) and Global Development Compliance partners is actioned to study execution teams
• Champion inspection readiness process improvements and provide direct change management support for clinical trial delivery projects and initiatives
• Coordinate and manage TMF process and inspection readiness strategies in collaboration with study execution teams and GCP Excellence in Clinical Trials leadership
• Provide project management, oversight, and expert GCP guidance to study execution teams in Inspection Readiness including, but not limited to, Inspection Readiness Plans, completion of Inspection Readiness Checklist, TMF quality and process adherence, identification & mitigation of inspection risks, storyboard development for high-risk issues, and creation of functional presentations in preparation for mock and actual inspection
• Manage study execution teams in prioritizing process adherence, inspection readiness deliverables, and mitigation of inspection risks throughout the study lifecycle
• Lead and guide study teams on adherence to ways of working and associated documentation and deliverables
• Collaborate cross-functionally and manage/action compliance monitoring signals with study execution teams. Provide reporting to senior leadership on key performance indicators and mitigation strategies related to clinical trial inspection readiness including quality TMF documentation
• Act as investigation lead for study specific quality events including corrective and preventative action management in partnership with QA and the study execution team
• Identify and engage appropriate Sponsor and CRO SMEs in the inspection readiness activities. Actively participate in Strategy Team Meetings and Lead Core Team Meetings for assigned Inspection Readiness projects
• Maintain documentation such as project management plans/trackers, timelines, and progress reports to track, manage, and report on study execution teams’ inspection readiness
• During inspections, manage functional teams by facilitating request strategies and responses with appropriate functional SMEs; providing necessary follow-up and guidance to ensure timely fulfillment; liaising with functional SMEs and QA to assure alignment; providing regular status updates to appropriate stakeholders and leadership
• Contribute to development of and lead assigned departmental objectives, representing GCP Excellence globally.
• Develop and implement GCP Excellence processes to enhance support and compliance, identifying areas for improvement.
• Manage study-execution teams in development of risk-based TMF oversight strategies.
• Monitor compliance of TMF deliverables and oversight of resources in the execution of inspection readiness plans.
• May serve as TMF subject matter expert for regulatory inspections of Takeda, responsible for ensuring execution of IR strategy and assist with presentation/representation of TMF Process to inspectorate
• May participate in management of day-to-day activities of assigned staff providing guidance, coaching and supporting issue escalation to achieve organizational and individual development goals.

Rare Disease Business Manager

Manager, Site Start Up

Senior Manager, Feasibility

Rare Disease Business Manager

Rare Disease Business Manager

Principal Electronic Data Capture Developer

Workday HCM Functional Analyst

Workday HCM Functional Analyst

Associate Director, GCP Compliance

Business Account Manager, PDT, Private

Network Manager, Gastrointestinal (GI)

Manager, Data Analytics

Manager, Patient Recruitment and Retention

Patient Recruitment and Retention Lead

Senior Manager, GCP Excellence – Clinical Trials