31 utility operator jobs found

CSL The Director, Medical Affairs Statistics will support product marketing by generation of scientifically valid evidence that goes beyond the product label. The successful incumbent will serve the knowledge needs of patient and prescriber communities that go beyond the targeted focus of regulators. Responsibilities and Accountabilities: Advising, planning and execution of exploratory analyses for secondary publications Input in CRO selection and participation in governance; direct and supervise programmers and CROs in the execution of exploratory analyses Statistical leadership and strategic partnering with key stakeholders for the design and analysis of registry trials and RWE (Real World Evidence) studies initiated by the commercial organization, including building strong relationships with quantitative counterparts in key partner organizations Statistical leadership and strategic partnering with key stakeholders for life-cycle-management (LCM) clinical trials...

CSL The Senior Manager of Contract Execution is responsible for developing, negotiating, and managing contracts that support CSL Behring's market access strategies. This role requires close collaboration with Market Access Accounts, Marketing, Pricing, Analytics, Sales, and other cross-functional commercial teams to ensure contracts are aligned with business objectives and executed efficiently. The ideal candidate will be a strong communicator and collaborator, with proven experience in managing complex contract processes and driving operational excellence. This position reports to the Associate Director, Contract Execution and works closely with internal stakeholders to ensure strategic alignment across the organization. Reporting Relationships Reports to: Associate Director, Contract Execution Direct Reports: None Key Responsibilities 1. Contract Execution Lead the development and negotiation of contracts to support market access. Manage the full...

CSL 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. The Senior Director, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development. This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders. The Senior Director manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional...

CSL 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. The Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical study(ies) and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical study (ies)/program(s). Responsibilities encompass support to the development of the operational strategy for our most complex studies and ensuring achievement of all program goals within established timelines, budget, and quality standards, and according to the TA strategies. This role must be experienced in working in a...

CSL CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Director, Epidemiology? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role three...

CSL CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager US Advertising and Promotion Lead? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Head, Global Advertising & Promotional Position Purpose Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties. Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products. Review, approve, or reject promotional...

CSL The Product Manager for ANDEMBRY will be responsible for supporting various components of the tactical plan, specifically focused on the HCP customers and field relationships. This role will support the ANDEMBRY brand director, and other members on the Brand Team, in creating and implementing key tactical initiatives to promote and differentiate ANDEMBRY to drive the positioning of "Maximum attack protection, simply achieved". The Product Manager will be involved in driving and measuring ANDEMBRY initiatives, such as Peer to Peer initiative, KOL management, Speaker Bureau management, as well as key point of contact for field materials and communications. The ideal candidate will have experience in rare disease, the ability to thrive in a fast-paced environment, be comfortable with managing multiple changes in direction and not afraid to work among ambiguity in certain situations. This role will need to proactively communicate with various functions across the commercial...

CSL Associate Director, Corporate & External Affairs, R&D Portfolio Position Purpose: The Associate Director, Corporate and External Affairs, R&D Portfolio will lead corporate and external affairs strategy for CSL's pipeline. The successful candidate will be responsible for driving communications for key pipeline milestones and clinical trials. They will serve as a strategic partner on R&D policy. They will lead issues and crisis management related to pipeline. In addition, they will strengthen the company's reputation within the Waltham biotech ecosystem and US to enhance and protect CSL's reputation and policy position. Reporting Relationships: Reports to: Head of Corporate and External Affairs, R&D Direct reports to position: 1 Main Responsibilities and Accountabilities: Serve as primary business partner and strategic advisor to SVP, Portfolio Development, SVP, GRAS and VP, Portfolio and Operations Excellence to shape...

CSL The Opportunity: 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. We are looking for a Associate Director, Case Management Intake & Submissions to join our R&D team. Under Case Intake, you will be responsible for the oversight of the Global Adverse Events Inbox, and all other Intake sources within CSL. You will also be responsible for ensuring accurate and timely entry of reports into the global safety database by the vendor. Under Case Submissions, you will be responsible for providing accurate implementation of global electronic ICSR reporting with Regulators, Partners or internal customers. Additionally, you will proactively monitor successful...

CSL The Opportunity: Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality , you will be responsible for ensuring optimal quality of Individual Case Safety Reports (ICSRs) in the Global Safety Database. You will perform end of line Quality Assurance (QA) check of ICSRs to ensure quality standards are maintained across CSL integrated and harmonized business units. This includes the quality of case processing vendors, generation of case quality metrics and trend analysis, and audit and inspection readiness and support. You will bring your expertise in case processing standards across all products, case types and processes globally, as this is required. In addition, you will provide Safety Database Train the Trainer sessions for case processing vendor at onset of services and end user training internally for CSL. This is a hybrid role, which offers a combination of an onsite and remote work schedule....

CSL The Opportunity: Reporting to the Director Strategic Sourcing Logistics & Warehousing, as the Sr. Manager, Regional Category - Logistics & Warehousing , you will manage the Americas portfolio of the key Global Logistics & Warehousing Category and will be responsible for the development and execution across CSL Behring, CSL Vifor and CSL Seqirus (the entire CSL Group) for the allocated category and region to ensure best value for CSL while managing risk and maintaining compliance in sourcing practices. You will lead and/or support global sourcing or bid activities, lead regional sourcing projects and activities and building and maintaining relationships with key stakeholders internal to CSL Group and within key regional vendors. This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid The Role: Develop Plans aligned to CSL Global and Procurement Strategy: Develop and implement annual action plans for...

CSL 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. Your role The incumbent will be responsible for the quality and delivery of high-quality clinical development documents and oversight of clinical study delivery across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and development of the clinical scientists and medical writing specialists in the group. Your responsibilities will include Oversight of Individuals Recruiting, staffing, training and development of clinical scientists and medical writing specialists in the group, to maintain a dynamic and cutting-edge level of medical scientific...

CSL Job Title: Associate Director, Strategic Forecasting and Portfolio Analytics Reporting to: Director, Strategic Forecasting & Portfolio Analytics Position Description Summary: * Reporting to the Director of Strategic Forecasting & Portfolio Analytics, you will lead forecasting programs centered around decision analytics for the CSL portfolio. * You will lead forecasting projects across Hematology CSL therapy area. This role will be the direct point of contact for all forecasting needs for the commercial development of in-line and pipeline assets * This position is critical for investigating and answering key business questions globally, influencing R&D and clinical programs, guiding asset strategy, and contributing to go-no-go decisions of various development programs across CSL * You will be a trusted partner, both within the Global Forecasting & Portfolio Analytics team and across the organization * You will lead the Long-Range Plan for...

CSL Responsible for defining and driving the digital architectural vision and strategy for R&D initiatives. This role will own the creation and maintenance of the R&D Digital Roadmap (City Plan) and the architectural decisions across the R&D Digital projects. This role acts as a bridge between scientific innovation and technical execution, ensuring the creation of scalable, secure, and high-performance systems that enable cutting-edge research and product development. Main Responsibilities & Accountabilities *Lead the design, development, and evolution of R&D systems architecture, including data pipelines, computational platforms, and integration frameworks*Collaborate with Digital Business Partners, scientists, engineers, and product teams to align architecture with R&D goals and overall business strategy*Evaluate emerging technologies and propose architectural innovations to enhance R&D productivity and enable next-generation research...

CSL 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. Could you be our next Director, Medical Writing Resourcing Group Lead? The job is in our King of Prussia, PA, Waltham MA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. Position Description Summary: You will be responsible for the provision of medical writing services to support clinical development by way of managing the Medical Writing budget project and functional budget, as well as ensuring the medical writing team is resourced appropriately to meet the demands of the portfolio. You are the key leadership role in the Clinical Development group,...

CSL Job Description CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Director, Head of Global Case Management ? The job is in our King of Prussia, PA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will be a strategic leader that ensures a lean, agile, and cost-efficient organization that delivers the highest standards of patient safety, while maintaining strict compliance with global regulations. The Head of Global Case Management will develop and implement innovative case management strategies across the Enterprise ensuring compliance with regulatory...

CSL The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program. Main Responsibilities: Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents. Provide statistical thought partnership for innovative study design and...

CSL Position Description Summary The External Digital Ecosystem Lead is a role in R&D responsible for managing and nurturing relationships with external partners, and suppliers within a digital framework. This role drives innovation and digital transformation by strategically connecting different players to create a collaborative network that enhances the customer/user experience and business value. This role oversees the development of platforms, partnerships, and services to ensure they work together seamlessly and create new opportunities. Main Responsibilities & Accountabilities Strategic vision : Define and execute the company's vision for its external digital ecosystem, identifying how partners, suppliers, and customers can create and exchange value. Partnership management : Build and maintain strong relationships with external partners, ensuring that the digital ecosystem is a win-win for all involved. Technology evaluation : Assess and integrate...

CSL The Associate Director, Field Reimbursement Manager Resourcing (FRM), US Portfolio, is responsible for developing and implementing in office resources and solutions across the portfolio to support HCP and patient access to CSL products. The individual will collaborate across functions in the development of customer specific needs delivered by a field-based reimbursement manager team. In addition, the incumbent will lead key go-to-market activities in preparation for launch and support the team in the development of customer needs by connecting larger market access requirements to local healthcare professionals. The role will be responsible for FRM resourcing across the portfolio, as aligned with brand needs. Main Responsibilities and Accountabilities: Lead market and customer insights to support access to US CSL Portfolio Develop resources in collaboration with FRM leadership to help advance access to CSL products Work closely US brand leaders, Patient...

CSL Main Responsibilities and Accountabilities: Position Qualifications and Experience Requirements: Accountable for the analysis and the generation of subnational and channel performance insights Execute analytics projects related to key customer or subnational views Implement a framework for integrating primary and secondary data sources to monitor performance and identify geographic trends across key customer channels (e.g., HCPs, HCOs, patients, SPs, payers) Partner with cross-functional leads to enhance business tools/processes, identify areas of improvement, and share best practices related to data and reporting Collaborate with field and account managers to support review performance and gather field intelligence Support strategic pull-through of brand initiatives related to accounts and channels Operationalize collaborative forums with field and corporate accounts leads to support strategic priorities, share intelligence, and generate actionable insights...