46 jobs found in King of Prussia

CSL Associate Director, Corporate & External Affairs, R&D Portfolio Position Purpose: The Associate Director, R&D Portfolio Corporate and External Affairs, will lead corporate and external affairs communication strategy for CSL's R&D portfolio 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 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, Global Regulatory Affairs &...

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 Senior Director Search & Evaluation Late TA Lead, (Im)? The job is in our King of Prussia PA, Waltham MA or Zurich Switzerland Office. This is a hybrid position and is onsite three days a week. Position Description Summary The Senior Director of Search & Evaluation will lead strategic sourcing and evaluation of later-stage external clinical assets in Immunology areas. You will focus on opportunities from Phase 2 through marketed drugs, requiring deep clinical expertise, strong engagement with external Key Opinion Leaders (KOLs) and clinical investigators, and a keen understanding...

CSL The Director, Statistical Programming provides leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. Manages a team of programmers supporting clinical trial and integrated analyses, annual reporting, regulatory responses, publications, HTA requests and other purposes as needed within one or more therapeutic areas. The individual will work closely with the Senior Director, Clinical and Statistical Programming to advance the internal programming environment and statistical programming processes. Works closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards. Main Responsibilities Working with the Biometrics Programming Leadership team, assess upcoming activities and resulting resource needs and allocate projects to people to ensure high...

CSL Position Summary: The Associate Director, Statistical Programming provides leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. The individual will work closely with the Director, Statistical Programming to ensure all assigned Statistical Programming tasks are managed to completion. They will work closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards. This individual may manage a Therapeutic Areas (TA) or programs within or across TAs working with the Statistics TA lead to ensure all work required in the TA is completed within the project timelines with high quality. Main Responsibilities and Accountabilities : Working with the Director, Programming to assess upcoming activities and resulting resource needs and ensure high quality,...

CSL Job description Senior Director Clinical Program Lead CVR You will be accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP). You are also accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment and is responsible for: the timely development and execution of the Clinical Development Plan (CDP). managing the day-to-day operations of the CDT including but not limited to meeting coordination and documentation, decision making, and stakeholder management. ensuring that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations. This position is accountable for the clinical & scientific oversight of the assigned program(s) and: ensures high quality clinical & scientific standards are met during all aspects of the program providing...

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 PV Assessment Lead and MSPR? The job is in our King of Prussia, PA Office. This is a hybrid position and is onsite three days a week. You will report to the Head of MSPR. You will be responsible for preparing adequate Pharmacovigilance assessments in the course of GMP deviation investigations, complaint investigations and other reports (e.g. BPDR, Monthly PV report to manufacturing site QA, PQR and APQR) on a high scientific level and in close cooperation with relevant stakeholders (e.g. Global Safety Lead, PTC team, QA managers). The position holder is responsible for the management and...

CSL Region; Mid West (ND,SD,NB,KS,MN,IA,MO,MI,IL,WI,IN,OH,KY) The Patient Resource Navigator will provide the Hemophilia B community with comprehensive, personalized support and education on gene therapy throughout the patient's journey. This individual will serve as a high-value source of information about gene therapy and will offer support and guidance to potential candidates for gene-therapy. The Patient Resource Navigator will educate patients, HCPs, and members of the bleeding disorders community regarding gene therapy as be part of a coordinated, field-based, regionally aligned team designed to represent CSL Behring to patients. Responsibilities: Educate patients on required steps that need to be taken prior to receiving treatment and provide information about CSL Behring patient support offerings Liaison between and hemophilia treatment centers, with CSL patient support case managers, , other CSL functions in order to ensure comprehensive patient support...

CSL FOR USE ONLY BY EARLY CAREERS PROGRAM PARTICIPANTS Responsibilities: * Professional induction: The intern/dual-student/co-op must familiarize themselves with their respective department and particular area according to the induction program. Gain an understanding of the processes and activities in the respective area and actively participate in them. * Execution of own tasks/projects: After an induction period, the Intern takes on his or her own tasks/(sub-)projects and executes them/ takes part of them independently. * Acquiring a foundational understanding of the department: By working in the business function, the Intern acquires a foundational understanding of the organization, processes and procedures in their function and the company. Understanding of the most important aspects and challenges as well as relevant interfaces and stakeholders. * General support to enable learning and development within the role and function for future application * Support of and attendance...

CSL FOR USE ONLY BY EARLY CAREERS PROGRAM PARTICIPANTS Responsibilities: * Professional induction: The intern/dual-student/co-op must familiarize themselves with their respective department and particular area according to the induction program. Gain an understanding of the processes and activities in the respective area and actively participate in them. * Execution of own tasks/projects: After an induction period, the Intern takes on his or her own tasks/(sub-)projects and executes them/ takes part of them independently. * Acquiring a foundational understanding of the department: By working in the business function, the Intern acquires a foundational understanding of the organization, processes and procedures in their function and the company. Understanding of the most important aspects and challenges as well as relevant interfaces and stakeholders. * General support to enable learning and development within the role and function for future application * Support of and attendance...

CSL The Opportunity: Reporting to the Senior Director, Head of People Analytics as the Director, People Analytics & Insights, you will lead the design and delivery of enterprise people analytics solutions that enable data-driven workforce planning, talent decisions, and organizational health monitoring across CSL. You will serve as a strategic advisor to HR leaders and business stakeholders, translating complex people data into actionable insights, executive-ready storytelling, and scalable analytics products that support business outcomes. You will will partner closely with HR Centers of Excellence (COEs), HR Business Partners (HRBPs), HR Operations, enterprise data teams, and Legal/Privacy to ensure data quality, governance, compliance, and continuous advancement of analytical maturity across the organization. This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid The Role: People Analytics Strategy, Solution Design...

CSL As the Senior Director, Medical Affairs, you will lead the development and execution of Medical Affairs strategies and tactics to support the Specialty Disease Area (DA). You will serve as the medical and scientific expert and represent current US medical practice to internal CSL Behring stakeholders. You will have a high awareness of patient needs, current therapeutic practices and new therapeutic trends in the US market. Essential to success is an outstanding partnership with the medical field team which will report to you through a Specialty Field Medical Director; and, with Market Access, and Commercial to maximize the value proposition of the medicines in your portfolio. Externally, you will assist health care professionals and payers to optimize patient care and treatment outcomes through evidence-based decisions. You will: Lead the US Medical team (Medical directors/scientists and Field MSL Lead) for the US Disease Area Develop and execute annual US Medical...

CSL The Senior Director, Operations Business Partner serves as the strategic, enterprise aligned partner and trusted advisor to the global Operations organization. This role provides end-to-end leadership across the full Operations value chain-including manufacturing, supply chain and quality- to drive business value through deliberate, integrated application of digital, data, automation, and platform capabilities. This role is not site specific and is designed to support CSL's shift toward an integrated global Operations model. The Senior Director ensures Operations is represented consistently and effectively in enterprise digital forums, drives cross Ops prioritization and investment alignment, and provides senior level leadership continuity across a wide and complex portfolio. This role will also advance CSL's U.S. footprint by anchoring digital leadership tied to CSL's major U.S. investment initiatives. Core responsibilities include: Enterprise portfolio...

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 Senior Biostatistician? The job is in our King of Prussia, PA, Waltham MA and Zurich Switzerland Office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats. The Senior Biostatistician provides and may lead statistical components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables. Responsibilities: 1. Input to statistical strategy and...

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. Lead the development, design, governance, implementation and continuous improvement of required Project Management Tools, Templates and standards for R&D to enable consistent, compliant, and high-quality project delivery across the R&D portfolio. Your Responsibilities & Accountabilities Design, develop, systematize and maintain a standardized suite of required tools, templates and supportive frameworks for R&D Project Management excellence. Primary focus is R&D Project Management within POE while serving as an extended Centre of Excellence on Project Management best practices across...

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 Principal Biostatistician? The job is in our King of Prussia, PA, Waltham MA and Zurich Switzerland Office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats. You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables Main Responsibilities: Input to statistical strategy and ensure appropriate statistical methodologies...

CSL Region- Upper Mid-Atlantic: (NJ, PA, OH, WV, DE, MD, DC) Main Responsibilities and Accountabilities: Acquire and maintain an advanced level of clinical-scientific knowledge in the assigned therapeutic area(s) and/or disease state(s) related to CSL Behring's products. Maintain a basic level of clinical-scientific knowledge about the broader portfolio of CSL Behring's products and the diseases they treat. Accurately and compliantly interpret and disseminate balanced and factual scientific, clinical, and health economic data. Gather and evaluate new information as it applies to CSL Behring's products and areas of therapeutic interest. Identify and engage appropriate regional Key Opinion Leaders (KOLs) and Healthcare Professionals (HCPs) in objective-based interactions with which to develop professional relationships and exchange clinical-scientific information relevant to CSL Behring's products and areas of therapeutic interest. Provide areas of interest and general...

CSL This position will lead the transformation of project leadership capabilities across the R&D enterprise. On a systemic level, this role will prepare critical GPL roles (Exec Directors) to be CEO of the project via a bespoke leadership/drug development/executive training and coaching program which will equip these leaders and associated project teams to navigate ambiguity, prioritize effectively, and make high-impact R&D investment decisions that accelerate innovation and deliver value to patients. This position will work with the CEO/GLG, RDLT and all levels to ensure the Project Operating Model is continuously improved for simple, rapid, empowered, project-centric decision making at the right level. This role will also lead the leadership development of Project Managers (PMs) and Research Project Leads (RPLs) in R&D and strengthen the GPL/GPM partnership. Main Responsibilities & Accountabilities *Develop and run an executive...

CSL Primary role Summary : The PSSI Lead supports the processes associated with start-up, site monitoring, oversight and site engagement but strives to identify innovative continuous improvement opportunities with keen business analytics. They are responsible to develop and review KPI s and metrics associated with start-up, site monitoring (onsite, remote and central) and site monitoring oversight. With KPIs established, this role will need to continually monitor performance and critically assess their impact and collaborate with appropriate groups and the SMMO LT to identify trends and resolve issues and delinquencies. The PSSI Lead monitors start-up, site monitoring and oversight processes at enterprise level using dashboards and analytics; and ensures compliance through SMMO & Partner follow-up in collaboration with Clinical Compliance. The PSSI Lead represents SMMO on SOP and process reviews, determines impact and provides recommendations or process improvement...

CSL The Opportunity: Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality , you will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma products. This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid The Role: Oversight of Global Case Management Pharmacovigilance vendor(s) as it relates to , governance, financials, contracts, quality and training, and resourcing. Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor. Oversee case management vendor(s) to manage and resolve emerging issues. Develop and/or maintain/ update...

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. You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization. Oversees Medical Evaluators responsible for medical review of ICSRs. Key Responsibilities Oversight of Case Management Processes activities Oversight of Medical Evaluator role which...