About One Network Enterprises One Network Enterprises (ONE), a Blue Yonder company, is the leader in supply chain autonomous planning, control towers, and provider of the Digital Supply Chain Network. It is the only solution that gives supply chain managers and executives end-to-end visibility and control with one data model and one truth, from raw material to last mile delivery. Powered by NEO, One Network's machine learning and intelligent agent technology, it enables seamless planning and execution, across inbound supply, outbound order fulfillment, and logistics, matching demand with available supply in real-time. Lead your industry by providing the highest service levels and product quality at the lowest possible cost. Visit: . Job Summary: The Director Product will be a member of the Product Management team for One Network Supply Chain Solution. The Product Director will drive the product planning process across cross-functional teams of the company with the knowledge of customer needs, current market trends, current competitor offerings, seeking opportunities for differentiation. The Product Manager will manage all life cycle stages for a product from ideation through sunset, with responsibility for ensuring that deliverables are understood and releases are delivered on time. The Product Manager will participate in customer demos, Presales and product development, including requirements analysis, design, prototyping, model building, and testing. Job Duties & Responsibilities: Drive the planning and execution of all product life cycle activities, including product research, market research, competitive analysis, roadmap planning, positioning, release scoping, and requirements development Collect and analyze feedback from customers, stakeholders and other teams to shape requirements, features and products Translate product strategy into detailed requirements for prototype construction and final product development by engineering teams Create product strategy documents that describe business cases, high-level use cases, technical requirements with clear articulation of business value aligned with company vision Manage agile product development process from product management point of view Collaborate closely with engineering, production, marketing, sales, pre-sales and solution implementation teams on the development, QA, and release of products and balance of resources to ensure success for the entire organization Develop product positioning and messaging that differentiates One Network and its features across primary market segments Serve as an in-house expert for our products and become the go-to person for all functional issues Demonstrate the product for specific customer needs & support pre-sales operations. Conceptualize and create Industry Solution Templates with detailed capability maps, process models, day-in-life documentation by business roles, and demo scripts Engage in major customer programs and lead solution architecture & design, aligned with Industry Solution Templates Education: BS/MS in Engineering, Computer Science, Supply Chain Job requirements and skills : Proven experience working as Product Manager or Solution Consultant in a non-managerial role implementing large scale complex supply chain & logistics solutions across various industry verticals. Experience with Supply Chain COTS Applications Strong experience in a dynamic product management role Proven experience overseeing all elements of the product development life cycle Highly effective cross-functional team management In-depth knowledge of Agile methodology for product development Outstanding communication, presentation and leadership skills Excellent organizational and time management skills Sharp analytic and problem-solving skills Creative thinker with a vision Previous software and web product development experience is a plus Benefits: Medical Life Dental Vision (many plans to choose from) 401k match Generous vacation time off Employee referral program Employee assistance program Note:We do not sponsor visas at this time. One Network promotes an equal opportunity workplace, which includes reasonable accommodation of otherwise qualified disabled applicants and employees so long as this does not create an undue hardship on the company. Please see your manager should you have any questions about this policy or these job duties. This job description may not be all-inclusive and employees are expected to perform all other duties as assigned and/or directed by management. Job descriptions and duties may be modified when deemed appropriate by management.
12/01/2024
Full time
About One Network Enterprises One Network Enterprises (ONE), a Blue Yonder company, is the leader in supply chain autonomous planning, control towers, and provider of the Digital Supply Chain Network. It is the only solution that gives supply chain managers and executives end-to-end visibility and control with one data model and one truth, from raw material to last mile delivery. Powered by NEO, One Network's machine learning and intelligent agent technology, it enables seamless planning and execution, across inbound supply, outbound order fulfillment, and logistics, matching demand with available supply in real-time. Lead your industry by providing the highest service levels and product quality at the lowest possible cost. Visit: . Job Summary: The Director Product will be a member of the Product Management team for One Network Supply Chain Solution. The Product Director will drive the product planning process across cross-functional teams of the company with the knowledge of customer needs, current market trends, current competitor offerings, seeking opportunities for differentiation. The Product Manager will manage all life cycle stages for a product from ideation through sunset, with responsibility for ensuring that deliverables are understood and releases are delivered on time. The Product Manager will participate in customer demos, Presales and product development, including requirements analysis, design, prototyping, model building, and testing. Job Duties & Responsibilities: Drive the planning and execution of all product life cycle activities, including product research, market research, competitive analysis, roadmap planning, positioning, release scoping, and requirements development Collect and analyze feedback from customers, stakeholders and other teams to shape requirements, features and products Translate product strategy into detailed requirements for prototype construction and final product development by engineering teams Create product strategy documents that describe business cases, high-level use cases, technical requirements with clear articulation of business value aligned with company vision Manage agile product development process from product management point of view Collaborate closely with engineering, production, marketing, sales, pre-sales and solution implementation teams on the development, QA, and release of products and balance of resources to ensure success for the entire organization Develop product positioning and messaging that differentiates One Network and its features across primary market segments Serve as an in-house expert for our products and become the go-to person for all functional issues Demonstrate the product for specific customer needs & support pre-sales operations. Conceptualize and create Industry Solution Templates with detailed capability maps, process models, day-in-life documentation by business roles, and demo scripts Engage in major customer programs and lead solution architecture & design, aligned with Industry Solution Templates Education: BS/MS in Engineering, Computer Science, Supply Chain Job requirements and skills : Proven experience working as Product Manager or Solution Consultant in a non-managerial role implementing large scale complex supply chain & logistics solutions across various industry verticals. Experience with Supply Chain COTS Applications Strong experience in a dynamic product management role Proven experience overseeing all elements of the product development life cycle Highly effective cross-functional team management In-depth knowledge of Agile methodology for product development Outstanding communication, presentation and leadership skills Excellent organizational and time management skills Sharp analytic and problem-solving skills Creative thinker with a vision Previous software and web product development experience is a plus Benefits: Medical Life Dental Vision (many plans to choose from) 401k match Generous vacation time off Employee referral program Employee assistance program Note:We do not sponsor visas at this time. One Network promotes an equal opportunity workplace, which includes reasonable accommodation of otherwise qualified disabled applicants and employees so long as this does not create an undue hardship on the company. Please see your manager should you have any questions about this policy or these job duties. This job description may not be all-inclusive and employees are expected to perform all other duties as assigned and/or directed by management. Job descriptions and duties may be modified when deemed appropriate by management.
The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). *Senior Director Operations* *About Satellite Healthcare* Satellite Healthcare is more than simply a dialysis company. Since our founding in 1974, we have become the industry's leader in personalized quality care: 70% of our centers earn 4- and 5-star ratings from Medicaid and Medicare.gov, far ahead of all other providers. Our success in caring for patients can be attributed to our mission, our not-for-profit structure, and our people. Together, they create a powerfully patient-centered organization. Our mission is clear: to make life better for people living with kidney disease. Because we are a non-profit, we can pursue that mission with all our resources, united by our passion for patient care. As part of our commitment to continuous improvement, Satellite Research explores new ways to elevate the effectiveness and delivery of dialysis therapy. And Satellite Wellbound is leading the industry in home dialysis because better outcomes and quality of life are our highest priority. We are also substantial contributors to community and philanthropic kidney initiatives. Across our organization, we share a single mission - to make life better for those living with kidney disease. [Watch our video to learn more about our mission.]() *About the Role* The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). The Operations Senior Director is a member of the dialysis team and leads and supports both the strategic and quality plans for a specific MSA of operations. The Sr Director of Operations provides supervision, mentoring and coaching to Center Managers within the MSA in all areas of responsibilities especially in quality and operations. Quality services are defined and measured for all patients based on the direction and guidance of the Chief Medical Officer (CMO). The Senior Director of Operations works collaboratively with the Medical Director(s) and Center Manager of each center to resolve issues and improve the overall performance of center. The Senior Director of Operations provides guidance and support to the local Quality Assurance Performance Improvement (QAPI) program including the patient experience. The Senior Director of Operations maintains a strong working relationship with physicians, medical practices and payers within their business area. The Senior Director of Operations works collaboratively with Medical Affairs and Business Development staff and other corporate departments to define, implement and evaluate corporate initiatives, and responds to specific direction from the Executive Team. The person in this position, if assigned to oversee a center with a DADS license, may also be designated as the Alternate Administrator, Alternate Supervising Nurse, or Director of Nursing. Essential Functions : *Operations* Market Service Area and Dialysis Center Leadership * Provides supervision, mentoring and advice to the Center Managers * Provides leadership and direction in the opening of new centers * Encourages and develops leadership at all levels of the organization * Provides corporate visibility and shares corporate communication with centers * Facilitates center management and the technical team in problem solving facility and supply issues/concerns * Supports matrix management as it functions with ancillary services including administrative functions, social work, nutrition, and quality * In absence of the Regional Vice President, the Senior Director of Operations has the authority to carry out responsibilities of the Regional Vice President for the MSA Employee Management * Plans and promotes all levels of staff involvement in the operations * Develops a recruitment and retention plan for the region with HR * Provides direction and supervision of hiring and disciplinary action at the center level and consults Human Resources when necessary * Reviews focal reviews with Center Managers, working collaboratively in assessing performance and setting goals * Utilizes the pyramid as a teaching tool for Clinical Management on staff development and retention * Monitors staff education and training programs * Promotes teamwork by offering information, advice, and assistance to all staff members in a positive, courteous, and cooperative manner * Contributes to Satellite being employer of choice Financial Oversight * Prepares and monitors, in collaboration with the Finance Department and clinical management staff, the operating and capital budgets for each center * Ensures that established financial targets are met * Works with Finance to support vendor contracts * Monitors the use of company guidelines for staffing ratios/patient scheduling * Identifies opportunities for cost savings in labor and supplies Regulatory Oversight * Ensures that centers operate in compliance with all State and Federal regulations, especially the CMS Conditions for Coverage for End Stage Renal Disease Facilities (Code of Federal Regulations 42, Federal Register of April 15, 2008) and the DHS Interpretive Guidelines * Ensures that Texas centers with a license from the Department of Aging and Disability Services ("DADS"), operate in compliance with all State and Federal regulations, including the Texas Administrative Code ("TAC"), Title 40, Part 1, Chapter 97 * Ensures that centers are in compliance with the submission of accurate data and other information to governing agencies (e.g. ESRD Networks) in a timely manner * Participates in mock surveys and holds Center Manager accountable for performance plans * Attends Governing Board Review at least twice a year at each center *Quality Assurance/Improvement/Outcomes* Quality Assurance/Improvement * Ensures and directs the quality programs of each center, to assure that Satellite QA/QI targets are met and standards of patient care are practiced * Works directly with the Director of Quality to coach and monitor the Center Managers in quality and improvement * Ensures quarterly QAPI meetings are held at each center and attends as needed * Provides new ideas and products to the Regional Vice President, CMO and Quality leadership Patient Care * Supports and contributes to the standardization of Satellite Policies & Procedures (P&Ps) * Coaches the Center Manager in the delivery of safe and effective patient care * Ensures that documentation and medical records practices are followed according to Satellite policy Customer Service/Patient Experience * Ensures that Center Managers are coordinating and delivering efficient services * Support Patient Experience with surveys and action plans to improve experience * Work with all aspects of Patient Experience: * Physician /patient relationship * Patient involvement/knowledge * Perception of staff awareness and compassion * Monitors and evaluates employee and provider satisfaction * Directs customer service standards and practices * Builds strong teams to support quality of care * Embraces and encourages the patient experience through education and feedback * Ensure staff awareness and participation in patient experience * Works directly with Medical Director to address communication with all physicians: * Responds to concerns or issues immediately and appropriately * Supports and coaches Medical Director in utilizing an effective QAPI process * Communicates clearly, concisely, collaboratively, and non-defensively with colleagues, direct reports, corporate staff, corporate management and Center staff * Builds and maintains relationships with key customers (Kaiser, HMOs, PPOs, etc.) * Conducts routine meetings with payers to improve communication and service * Ensures compliance with oversight and regulatory needs of the provider *Business Area Relationships* Strategic Planning * Understands and drives organic growth within a geographic area * Communicates market share trends and growth opportunities to Business Development * Monitors occupancy of centers and makes recommendations on expansion or reduction in capacity * Establishes relationships with key stakeholders in region (hospitals, payers, physicians, case managers, discharge planners, etc.) * Investigates innovative practices to differentiate Satellite from competitors Physician/ Payer Relationships * Builds and nurtures Physician's relationship with Medical Director and all referring physicians * Looks for opportunities to align new physicians with Satellite * Responds to requests and ideas on a routine basis * Participates in physician meetings or conferences * Extends knowledge and support to resolve both patient and administrative issues * Works with payers to address their needs or concerns * Listens to new ideas or ways to improve Satellite services *Corporate Direction* Business Plan * Directs the strategic plan for the business region * Updates demographics of each center * Maintains a market awareness of providers, competitors, or other business opportunities * Works with business development to enhance market development * Develops and nurtures provider partnerships * Builds and support physician relationships Supports Quality Plan * Working with colleagues..... click apply for full job details
09/24/2021
The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). *Senior Director Operations* *About Satellite Healthcare* Satellite Healthcare is more than simply a dialysis company. Since our founding in 1974, we have become the industry's leader in personalized quality care: 70% of our centers earn 4- and 5-star ratings from Medicaid and Medicare.gov, far ahead of all other providers. Our success in caring for patients can be attributed to our mission, our not-for-profit structure, and our people. Together, they create a powerfully patient-centered organization. Our mission is clear: to make life better for people living with kidney disease. Because we are a non-profit, we can pursue that mission with all our resources, united by our passion for patient care. As part of our commitment to continuous improvement, Satellite Research explores new ways to elevate the effectiveness and delivery of dialysis therapy. And Satellite Wellbound is leading the industry in home dialysis because better outcomes and quality of life are our highest priority. We are also substantial contributors to community and philanthropic kidney initiatives. Across our organization, we share a single mission - to make life better for those living with kidney disease. [Watch our video to learn more about our mission.]() *About the Role* The Sr Director of Operations is responsible to the Regional Vice President for operational oversight and administration of dialysis services within a specified Market Service Area (MSA). The Operations Senior Director is a member of the dialysis team and leads and supports both the strategic and quality plans for a specific MSA of operations. The Sr Director of Operations provides supervision, mentoring and coaching to Center Managers within the MSA in all areas of responsibilities especially in quality and operations. Quality services are defined and measured for all patients based on the direction and guidance of the Chief Medical Officer (CMO). The Senior Director of Operations works collaboratively with the Medical Director(s) and Center Manager of each center to resolve issues and improve the overall performance of center. The Senior Director of Operations provides guidance and support to the local Quality Assurance Performance Improvement (QAPI) program including the patient experience. The Senior Director of Operations maintains a strong working relationship with physicians, medical practices and payers within their business area. The Senior Director of Operations works collaboratively with Medical Affairs and Business Development staff and other corporate departments to define, implement and evaluate corporate initiatives, and responds to specific direction from the Executive Team. The person in this position, if assigned to oversee a center with a DADS license, may also be designated as the Alternate Administrator, Alternate Supervising Nurse, or Director of Nursing. Essential Functions : *Operations* Market Service Area and Dialysis Center Leadership * Provides supervision, mentoring and advice to the Center Managers * Provides leadership and direction in the opening of new centers * Encourages and develops leadership at all levels of the organization * Provides corporate visibility and shares corporate communication with centers * Facilitates center management and the technical team in problem solving facility and supply issues/concerns * Supports matrix management as it functions with ancillary services including administrative functions, social work, nutrition, and quality * In absence of the Regional Vice President, the Senior Director of Operations has the authority to carry out responsibilities of the Regional Vice President for the MSA Employee Management * Plans and promotes all levels of staff involvement in the operations * Develops a recruitment and retention plan for the region with HR * Provides direction and supervision of hiring and disciplinary action at the center level and consults Human Resources when necessary * Reviews focal reviews with Center Managers, working collaboratively in assessing performance and setting goals * Utilizes the pyramid as a teaching tool for Clinical Management on staff development and retention * Monitors staff education and training programs * Promotes teamwork by offering information, advice, and assistance to all staff members in a positive, courteous, and cooperative manner * Contributes to Satellite being employer of choice Financial Oversight * Prepares and monitors, in collaboration with the Finance Department and clinical management staff, the operating and capital budgets for each center * Ensures that established financial targets are met * Works with Finance to support vendor contracts * Monitors the use of company guidelines for staffing ratios/patient scheduling * Identifies opportunities for cost savings in labor and supplies Regulatory Oversight * Ensures that centers operate in compliance with all State and Federal regulations, especially the CMS Conditions for Coverage for End Stage Renal Disease Facilities (Code of Federal Regulations 42, Federal Register of April 15, 2008) and the DHS Interpretive Guidelines * Ensures that Texas centers with a license from the Department of Aging and Disability Services ("DADS"), operate in compliance with all State and Federal regulations, including the Texas Administrative Code ("TAC"), Title 40, Part 1, Chapter 97 * Ensures that centers are in compliance with the submission of accurate data and other information to governing agencies (e.g. ESRD Networks) in a timely manner * Participates in mock surveys and holds Center Manager accountable for performance plans * Attends Governing Board Review at least twice a year at each center *Quality Assurance/Improvement/Outcomes* Quality Assurance/Improvement * Ensures and directs the quality programs of each center, to assure that Satellite QA/QI targets are met and standards of patient care are practiced * Works directly with the Director of Quality to coach and monitor the Center Managers in quality and improvement * Ensures quarterly QAPI meetings are held at each center and attends as needed * Provides new ideas and products to the Regional Vice President, CMO and Quality leadership Patient Care * Supports and contributes to the standardization of Satellite Policies & Procedures (P&Ps) * Coaches the Center Manager in the delivery of safe and effective patient care * Ensures that documentation and medical records practices are followed according to Satellite policy Customer Service/Patient Experience * Ensures that Center Managers are coordinating and delivering efficient services * Support Patient Experience with surveys and action plans to improve experience * Work with all aspects of Patient Experience: * Physician /patient relationship * Patient involvement/knowledge * Perception of staff awareness and compassion * Monitors and evaluates employee and provider satisfaction * Directs customer service standards and practices * Builds strong teams to support quality of care * Embraces and encourages the patient experience through education and feedback * Ensure staff awareness and participation in patient experience * Works directly with Medical Director to address communication with all physicians: * Responds to concerns or issues immediately and appropriately * Supports and coaches Medical Director in utilizing an effective QAPI process * Communicates clearly, concisely, collaboratively, and non-defensively with colleagues, direct reports, corporate staff, corporate management and Center staff * Builds and maintains relationships with key customers (Kaiser, HMOs, PPOs, etc.) * Conducts routine meetings with payers to improve communication and service * Ensures compliance with oversight and regulatory needs of the provider *Business Area Relationships* Strategic Planning * Understands and drives organic growth within a geographic area * Communicates market share trends and growth opportunities to Business Development * Monitors occupancy of centers and makes recommendations on expansion or reduction in capacity * Establishes relationships with key stakeholders in region (hospitals, payers, physicians, case managers, discharge planners, etc.) * Investigates innovative practices to differentiate Satellite from competitors Physician/ Payer Relationships * Builds and nurtures Physician's relationship with Medical Director and all referring physicians * Looks for opportunities to align new physicians with Satellite * Responds to requests and ideas on a routine basis * Participates in physician meetings or conferences * Extends knowledge and support to resolve both patient and administrative issues * Works with payers to address their needs or concerns * Listens to new ideas or ways to improve Satellite services *Corporate Direction* Business Plan * Directs the strategic plan for the business region * Updates demographics of each center * Maintains a market awareness of providers, competitors, or other business opportunities * Works with business development to enhance market development * Develops and nurtures provider partnerships * Builds and support physician relationships Supports Quality Plan * Working with colleagues..... click apply for full job details
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director, Process Excellence & Standards will set strategy and direction for the Process Excellence & Standards organization within Global Clinical Operations & Planning and play a key role in implementing and maintaining a continuous process improvement framework for the design and implementation of end-to-end clinical trial processes including rollout of a Process Council, kick-off of cross-functional Process Teams, and implementation of new roles (Process Owner and Process Manager/Specialist). Under the leadership of the Sr. Director, the Process Excellence & Standards group will also be responsible for developing process documentation and SOPs, GCP training and broader Learning and Development activities, metrics & benchmarking, and clinical quality management including tracking of GCP deviations/nonconformances, CAPA management, and inspection readiness. Responsibilities: Set strategy and direction for the Process Excellence & Standards Center of Excellence within Global Clinical Operations & Planning encompassing business process management, training, and clinical quality management Partner with functional leaders and Process Owners to shape and implement a continuous process improvement (CPI) framework for end-to-end clinical trial processes including rollout of Process Council, kick-off of Process Teams, and implementation of Process Owner and Process Manager/Specialist roles Serve as Chief of Staff for the Process Council, working with the committee chairs, members, and Process Teams to facilitate high-level governance of process improvement (strategy, prioritization, guidance, support and issue resolution) and maintenance of a continuous improvement plan for DS's portfolio of processes Establish a Process Owner/Process Manager forum to drive the change to CPI model and ensure consistency/connectivity across processes. In addition, keeps abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to processes and proactively initiates discussions and process changes Work with Process Managers and Metrics/Benchmarking lead to ensure that appropriate process performance metrics are maintained and actively deployed to diagnose and address process gaps/deficiencies Support the efforts of Process Owners/Process Managers to drive change management and implementation of major process design changes Partner with QA to ensure that clinical SOPs and GCP training are up-to-date, GCP deviations/nonconformances are tracked and addressed, and to ensure inspection readiness and CAPA management for items under GCO responsibility Shape training and development strategies of GCOP staff through deployment of a GCO training center of excellence Recruit, train, coach and develop staff to ensure development and deployment of key capabilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree with minimum of 10 years' experience in pharmaceutical or biotechnology drug development. Significant experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, clinical QA) Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements Strong leadership, collaboration, and influencing skills including team leadership or functional management Experience in clinical trial process design, harmonization/optimization, process implementation, and change management Knowledge and understanding of GCPs and applicable regulatory guidelines governing clinical trials and clinical quality management Experience with delivering presentations before executive staff Previous experience working in cross-functional study teams/ projects and/or ability to establish and manage relationships Effective and influential communication, self-management, problem solving and organizational skills Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Process Excellence & CRO Alliance Mgmt City Basking Ridge Functional Area Global Clinical Operations & Planning State New Jersey
01/15/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director, Process Excellence & Standards will set strategy and direction for the Process Excellence & Standards organization within Global Clinical Operations & Planning and play a key role in implementing and maintaining a continuous process improvement framework for the design and implementation of end-to-end clinical trial processes including rollout of a Process Council, kick-off of cross-functional Process Teams, and implementation of new roles (Process Owner and Process Manager/Specialist). Under the leadership of the Sr. Director, the Process Excellence & Standards group will also be responsible for developing process documentation and SOPs, GCP training and broader Learning and Development activities, metrics & benchmarking, and clinical quality management including tracking of GCP deviations/nonconformances, CAPA management, and inspection readiness. Responsibilities: Set strategy and direction for the Process Excellence & Standards Center of Excellence within Global Clinical Operations & Planning encompassing business process management, training, and clinical quality management Partner with functional leaders and Process Owners to shape and implement a continuous process improvement (CPI) framework for end-to-end clinical trial processes including rollout of Process Council, kick-off of Process Teams, and implementation of Process Owner and Process Manager/Specialist roles Serve as Chief of Staff for the Process Council, working with the committee chairs, members, and Process Teams to facilitate high-level governance of process improvement (strategy, prioritization, guidance, support and issue resolution) and maintenance of a continuous improvement plan for DS's portfolio of processes Establish a Process Owner/Process Manager forum to drive the change to CPI model and ensure consistency/connectivity across processes. In addition, keeps abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to processes and proactively initiates discussions and process changes Work with Process Managers and Metrics/Benchmarking lead to ensure that appropriate process performance metrics are maintained and actively deployed to diagnose and address process gaps/deficiencies Support the efforts of Process Owners/Process Managers to drive change management and implementation of major process design changes Partner with QA to ensure that clinical SOPs and GCP training are up-to-date, GCP deviations/nonconformances are tracked and addressed, and to ensure inspection readiness and CAPA management for items under GCO responsibility Shape training and development strategies of GCOP staff through deployment of a GCO training center of excellence Recruit, train, coach and develop staff to ensure development and deployment of key capabilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree with minimum of 10 years' experience in pharmaceutical or biotechnology drug development. Significant experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, clinical QA) Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements Strong leadership, collaboration, and influencing skills including team leadership or functional management Experience in clinical trial process design, harmonization/optimization, process implementation, and change management Knowledge and understanding of GCPs and applicable regulatory guidelines governing clinical trials and clinical quality management Experience with delivering presentations before executive staff Previous experience working in cross-functional study teams/ projects and/or ability to establish and manage relationships Effective and influential communication, self-management, problem solving and organizational skills Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Process Excellence & CRO Alliance Mgmt City Basking Ridge Functional Area Global Clinical Operations & Planning State New Jersey
