Johnson & Johnson
Walters Ash, Buckinghamshire
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: People Leader All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at The Programming Director is a highly experienced functional area leader with expert knowledge of Programming strategy concepts and processes, industry standards and complex data structures and reporting solutions. This position requires expert project and people leadership skills with the capability to effectively manage programming support across a large portfolio across one or more therapeutic areas and/or disease area strongholds, and all phases of development. This position is accountable for programming strategy and delivery of the assigned area in accordance with company and departmental processes and procedures. In collaboration with departmental and cross-functional leadership/key stakeholders, this position also contributes to process optimization and innovation while ensuring appropriate cross-functional alignment and engagement when necessary. As such this position is accountable to drive the overall technical capability strategy and process solutions delivering increased productivity, quality, performance and innovation within the programming functional area. As a people and organizational leader, this position is accountable for the recruitment, performance management, talent development, and resource management within their assigned area to meet current and future business needs, contributing to the overall talent management and sourcing strategy for the department. As a member of the C&S&SP Leadership Team, this position provides input into overall departmental strategy and drives the development and continuous improvement of departmental policies, procedures, training, and standards. Principal Responsibilities: Delivery Unit or Disease Area Stronghold Leader: Accountable for the operational delivery, quality, and compliance of the assigned portfolio across one or more therapeutic areas and/or disease area strongholds, encompassing all phases of development. Provides input and oversight of regulatory submission strategy related to functional deliverables, where applicable. Collaborates with departmental leadership to oversee and coordinate sourcing, budget planning, and strategy for the assigned area. Contributes to decisions on business and sourcing strategy, processes, and resource allocation across sites. Accountable for driving the overall technical capability strategy and process solutions to enhance productivity, quality, performance, and innovation within the functional area. Identifies and drives process optimization and innovation within the assigned area, ensuring alignment of processes and procedures across the organization. Manages process and policy compliance in accordance with global, local and project requirements. Ensures appropriate documentation and/or corrective and preventative action planning related to process exceptions or deviations. Collaborates and partners with cross-functional leadership to address and resolve issues, championing best practices. Collaborates with vendors to optimize sourcing strategies and decisions, ensuring appropriate oversight and governance of vendor engagements. Develops and maintains policies and standards applicable across the organization, ensuring compliance within the assigned area. Regularly meets with direct reports to ensure consistency and appropriate progress towards project goals. People Leader: Accountable for attracting, hiring, and retaining top talent, managing performance, and actively supporting talent development and succession planning. Responsible for making decisions related to the management of assigned personnel and local administration including space allocation, supplies, budget, and travel, etc. Ensures training compliance and development of appropriate job skills for assigned personnel and organization. Oversees work allocation for direct reports, providing coaching and guidance as necessary. Collaborates with departmental leadership and partner and stakeholder functions to ensure alignment of departmental roles and responsibilities. As a member of the Clinical & Statistical Programming Leadership Team shaping departmental strategy and implementation: Contributes to the development and implementation of the functional strategy and vision to meet current and future needs, staying updated with industry trends and policies. Provides strategic input and direction in the evaluation and reassessment of departmental policies, procedures, best practices and sponsorship of initiatives and projects. Owns one or more business processes/procedures, ensuring they are current and efficient. Participates in and/or leads global cross-functional and cross-company initiatives, as applicable. Principal Relationships: This role reports into a people manager position within the Delivery unit and is accountable to the Senior Director of Programming for assigned activities and responsibilities. Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations. Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources. External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups. Education and Experience Requirements: Bachelor's degree (e.g., BS, BA) or higher and/or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth) Advanced degrees preferred (e.g., Master, PhD). Approx. 10+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. Approximately 10+ years clinical programming, data management or statistical programming experience within the pharmaceutical/clinical trial environment with proven experience in leadership roles. Excellent people leadership skills. People management experience of 5+ years is strongly preferred. Extensive understanding of programming practices and systems with strong general knowledge of clinical operations. Established track record working on cross-functional teams in a matrix environment and partnering with/managing stakeholders and customers. Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g. working with CROs, academic institutions). Excellent communication, leadership, influencing and decision-making skills, and proven ability to foster team productivity and cohesiveness, acting as a change agent, and adapting to rapidly changing organization and business environments. Demonstrated people management skills and experience in staff performance management and people development. In-depth knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies. If you're passionate about leveraging data science and statistic to drive impactful innovations, we'd love to hear from you! Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law . click apply for full job details
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: People Leader All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at The Programming Director is a highly experienced functional area leader with expert knowledge of Programming strategy concepts and processes, industry standards and complex data structures and reporting solutions. This position requires expert project and people leadership skills with the capability to effectively manage programming support across a large portfolio across one or more therapeutic areas and/or disease area strongholds, and all phases of development. This position is accountable for programming strategy and delivery of the assigned area in accordance with company and departmental processes and procedures. In collaboration with departmental and cross-functional leadership/key stakeholders, this position also contributes to process optimization and innovation while ensuring appropriate cross-functional alignment and engagement when necessary. As such this position is accountable to drive the overall technical capability strategy and process solutions delivering increased productivity, quality, performance and innovation within the programming functional area. As a people and organizational leader, this position is accountable for the recruitment, performance management, talent development, and resource management within their assigned area to meet current and future business needs, contributing to the overall talent management and sourcing strategy for the department. As a member of the C&S&SP Leadership Team, this position provides input into overall departmental strategy and drives the development and continuous improvement of departmental policies, procedures, training, and standards. Principal Responsibilities: Delivery Unit or Disease Area Stronghold Leader: Accountable for the operational delivery, quality, and compliance of the assigned portfolio across one or more therapeutic areas and/or disease area strongholds, encompassing all phases of development. Provides input and oversight of regulatory submission strategy related to functional deliverables, where applicable. Collaborates with departmental leadership to oversee and coordinate sourcing, budget planning, and strategy for the assigned area. Contributes to decisions on business and sourcing strategy, processes, and resource allocation across sites. Accountable for driving the overall technical capability strategy and process solutions to enhance productivity, quality, performance, and innovation within the functional area. Identifies and drives process optimization and innovation within the assigned area, ensuring alignment of processes and procedures across the organization. Manages process and policy compliance in accordance with global, local and project requirements. Ensures appropriate documentation and/or corrective and preventative action planning related to process exceptions or deviations. Collaborates and partners with cross-functional leadership to address and resolve issues, championing best practices. Collaborates with vendors to optimize sourcing strategies and decisions, ensuring appropriate oversight and governance of vendor engagements. Develops and maintains policies and standards applicable across the organization, ensuring compliance within the assigned area. Regularly meets with direct reports to ensure consistency and appropriate progress towards project goals. People Leader: Accountable for attracting, hiring, and retaining top talent, managing performance, and actively supporting talent development and succession planning. Responsible for making decisions related to the management of assigned personnel and local administration including space allocation, supplies, budget, and travel, etc. Ensures training compliance and development of appropriate job skills for assigned personnel and organization. Oversees work allocation for direct reports, providing coaching and guidance as necessary. Collaborates with departmental leadership and partner and stakeholder functions to ensure alignment of departmental roles and responsibilities. As a member of the Clinical & Statistical Programming Leadership Team shaping departmental strategy and implementation: Contributes to the development and implementation of the functional strategy and vision to meet current and future needs, staying updated with industry trends and policies. Provides strategic input and direction in the evaluation and reassessment of departmental policies, procedures, best practices and sponsorship of initiatives and projects. Owns one or more business processes/procedures, ensuring they are current and efficient. Participates in and/or leads global cross-functional and cross-company initiatives, as applicable. Principal Relationships: This role reports into a people manager position within the Delivery unit and is accountable to the Senior Director of Programming for assigned activities and responsibilities. Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations. Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources. External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups. Education and Experience Requirements: Bachelor's degree (e.g., BS, BA) or higher and/or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth) Advanced degrees preferred (e.g., Master, PhD). Approx. 10+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. Approximately 10+ years clinical programming, data management or statistical programming experience within the pharmaceutical/clinical trial environment with proven experience in leadership roles. Excellent people leadership skills. People management experience of 5+ years is strongly preferred. Extensive understanding of programming practices and systems with strong general knowledge of clinical operations. Established track record working on cross-functional teams in a matrix environment and partnering with/managing stakeholders and customers. Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g. working with CROs, academic institutions). Excellent communication, leadership, influencing and decision-making skills, and proven ability to foster team productivity and cohesiveness, acting as a change agent, and adapting to rapidly changing organization and business environments. Demonstrated people management skills and experience in staff performance management and people development. In-depth knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies. If you're passionate about leveraging data science and statistic to drive impactful innovations, we'd love to hear from you! Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law . click apply for full job details
CSL Behring
Maidenhead, Berkshire
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. You will be responsible for the management and oversight of the activities performed by ICSR Quality Control resources, Managed Services and QA & Compliance Oversight team. The incumbent Interfaces to support PV Operations strategy and initiatives. Key Responsibilities Accountable for Case Management's outsourcing strategy to support new acquisitions, integrations, expansion into new regions and company growth. Strategic Oversight of Global Case Management Pharmacovigilance vendors as it relates to governance, financials, contracts, reporting, training, and resourcing. Strategic Oversight of Global ICSR Quality Assurance activities. Oversight of Global ICSR Reconciliation activities. Develop and maintain workload metrics related to case volume and resources; adjust workload distribution and vendor resources based on existing or anticipated changes to case volume in order to maintain compliance and overall quality. Develop and/or update existing standard operational procedures (SOPs) for relevant functional responsibilities. Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required. Skills and Experience Required Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience. Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations. Experience working with third parties (e.g., contract service providers) and relationship management Qualifications and Education Required BS/BA, RN, Pharmacist, or equivalent. Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL Do work that matters at CSL Behring!
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. You will be responsible for the management and oversight of the activities performed by ICSR Quality Control resources, Managed Services and QA & Compliance Oversight team. The incumbent Interfaces to support PV Operations strategy and initiatives. Key Responsibilities Accountable for Case Management's outsourcing strategy to support new acquisitions, integrations, expansion into new regions and company growth. Strategic Oversight of Global Case Management Pharmacovigilance vendors as it relates to governance, financials, contracts, reporting, training, and resourcing. Strategic Oversight of Global ICSR Quality Assurance activities. Oversight of Global ICSR Reconciliation activities. Develop and maintain workload metrics related to case volume and resources; adjust workload distribution and vendor resources based on existing or anticipated changes to case volume in order to maintain compliance and overall quality. Develop and/or update existing standard operational procedures (SOPs) for relevant functional responsibilities. Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required. Skills and Experience Required Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience. Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations. Experience working with third parties (e.g., contract service providers) and relationship management Qualifications and Education Required BS/BA, RN, Pharmacist, or equivalent. Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL Do work that matters at CSL Behring!