The Director of Health Economics and Outcomes Research (HEOR) will be leading the development and execution of HEOR strategies for CSL Behring or Vifor assets primarily within a specific disease area. This role focuses on leading the plan, execution and dissemination of the payer evidence generation to maximize the asset's value throughout its life cycle by securing and optimizing product pricing and reimbursement.The position requires deep expertise in Health Economics, Real-World Evidence (RWE), and Health Technology Assessment (HTA) and a hands-on approach to executing HTA submissions and RWE studies.In this position you will be directly reporting to the Executive Director HEOR, Market Access.Potential locations: Switzerland (Zurich) or USA (King of Prussia).Key Responsibilities:Lead development, oversight, and execution of comprehensive and effective HEOR strategies demonstrating the value of CSL's products to enable fast and optimal access worldwide.Plan, execute and disseminate global value evidence generation studies and tools, such us Burden of Illness studies, Patient Preference and Patient Report Outcomes studies, Systematic Literature Reviews, Indirect Treatment Comparisons, Global Value Dossier, economic models, practical HEOR tools for payer engagement etc.Engage with the Access Leads and Product Strategy Teams to facilitate early and appropriate evidence generation in pivotal trials, identify gaps, and shape mitigation strategies for worldwide HTA's.Support Access leads in planning and conducting Early Scientific Advice with key P&R and HTA agencies.Shape pivotal trial design to adequately reflect payer evidence requirements, especially PICO (population, intervention, comparator, outcomes), devise mitigation strategies early on.Collaborate with Medical Affairs, Epidemiology, Biostatistics and other relevant functions to develop and execute integrated evidence generation plans, driving value evidence needs definition, execution and compliant dissemination/communication based on the strategic objectives of the brand plan.Lead cross-functional team to prepare EU JCA dossier and JSC/payer consultations, ensuring cross-functional alignment and seamless execution.Support and ensure governance of local HTA submissions, adapting global HEOR value dossiers, health economic models and tools and anticipating evidence needs.Ensure HEOR initiatives are aligned with the business needs and adequately funded.Foster the collaboration with KOLs and internal and external partners to introduce innovative approaches and methods and validate the HEOR strategy.Support the shaping and sharing of internal processes, procedures, approaches and best practices to elevate HEOR effectiveness.Educate stakeholders on HTA and value evidence key requirements and developments.Qualifications:Experience: At least 10 years of experience in HEOR/market access, with significant exposure to healthcare systems in international markets.Excellent analytical skills with experience in statistical modeling, data analysis, and interpretation of research findings.Track Record: Demonstrated success in developing and executing HEOR and HTA strategies to secure and optimize pricing, reimbursement, and patient access.Knowledge: Extensive understanding of HTA and benefit assessment processes and dynamics in key international markets.Collaboration: Proven ability to work effectively in cross-functional teams, with strong communication and influencing skills.Education: An advanced degree in Health Economics, Public Health, or a related field is required.Are you interested in this exciting opportunity? We are looking forward to receiving your online application. About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
The Associate Director of Health Economics and Outcomes Research (HEOR) will be leading the development and execution of HEOR strategies for CSL Behring or Vifor assets primarily within a specific disease area. This role focuses on leading the plan, execution and dissemination of the payer evidence generation to maximize the asset's value throughout its life cycle by securing and optimizing product pricing and reimbursement.The position requires deep expertise in Health Economics, Real-World Evidence (RWE), and Health Technology Assessment (HTA) and a hands-on approach to executing HTA submissions and RWE studies.In this position you will be directly reporting to the Executive Director HEOR, Market Access.Potential locations: Switzerland (Zurich) or USA (King of Prussia).Key Responsibilities:Lead development, oversight, and execution of comprehensive and effective HEOR strategies demonstrating the value of CSL's products to enable fast and optimal access worldwide.Plan, execute and disseminate global value evidence generation studies and tools, such us Burden of Illness studies, Patient Preference and Patient Report Outcomes studies, Systematic Literature Reviews, Indirect Treatment Comparisons, Global Value Dossier, economic models, practical HEOR tools for payer engagement etc.Engage with the Access Leads and Product Strategy Teams to facilitate early and appropriate evidence generation in pivotal trials, identify gaps, and shape mitigation strategies for worldwide HTA's.Support Access leads in planning and conducting Early Scientific Advice with key P&R and HTA agencies.Shape pivotal trial design to adequately reflect payer evidence requirements, especially PICO (population, intervention, comparator, outcomes), devise mitigation strategies early on.Collaborate with Medical Affairs, Epidemiology, Biostatistics and other relevant functions to develop and execute integrated evidence generation plans, driving value evidence needs definition, execution and compliant dissemination/communication based on the strategic objectives of the brand plan.Lead cross-functional team to prepare EU JCA dossier and JSC/payer consultations, ensuring cross-functional alignment and seamless execution.Support and ensure governance of local HTA submissions, adapting global HEOR value dossiers, health economic models and tools and anticipating evidence needs.Ensure HEOR initiatives are aligned with the business needs and adequately funded.Foster the collaboration with KOLs and internal and external partners to introduce innovative approaches and methods and validate the HEOR strategy.Support the shaping and sharing of internal processes, procedures, approaches and best practices to elevate HEOR effectiveness.Educate stakeholders on HTA and value evidence key requirements and developments.Qualifications:Experience: At least 8 years of experience in HEOR/market access, with significant exposure to healthcare systems in international markets.Excellent analytical skills with experience in statistical modeling, data analysis, and interpretation of research findings.Track Record: Demonstrated success in developing and executing HEOR and HTA strategies to secure and optimize pricing, reimbursement, and patient access.Knowledge: Extensive understanding of HTA and benefit assessment processes and dynamics in key international markets.Collaboration: Proven ability to work effectively in cross-functional teams, with strong communication and influencing skills.Education: An advanced degree in Health Economics, Public Health, or a related field is required.Are you interested in this exciting opportunity? We are looking forward to receiving your online application. About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
The Director of HTA & RWE will be responsible for building and continuously improve the forward-looking HTA (Health Technology Assessment) and payer relevant RWE (Real-World Evidence) capability within the global market access function.This role is pivotal in monitoring HTA and RWE trend world-wide, assessing and disseminating HTA methodology, building effective external engagement with HTA and key agencies, advising and educating internal teams to increase internal effectiveness in executing HTA submission and RWE studies.This role may at times support the HEOR product team in executing product-specific projects.In this position you will be directly reporting to the Executive Director HEOR, Market Access. Potential locations: Switzerland (Zurich) or USA (King of Prussia).Key Responsibilities:Build and continuously improve the forward-looking HTA and payer relevant RWE capability within the global market access function.Ensure competitiveness and effectiveness of the organization in navigating the complex and rapidly evolving landscape of HTA and RWE.Monitoring Trends: Stay updated on global HTA and RWE trends, methodologies, and guidelines to inform strategy and best practices.Assessment and Dissemination: Assess methodologies and disseminate findings to internal teams and stakeholders to ensure compliance and effectiveness in HTA submissions and RWE studies execution.External Engagement: Cultivate and maintain relationships with key HTA agencies, payers, industry associations, academic institutions, and external stakeholders to foster collaboration and gather insights.Internal Guidance and Advocacy: Advise and educate internal teams on HTA submission processes and payer relevant RWE study design to enhance internal capabilities and effectiveness.Support HEOR Product Teams: Collaborate with the HEOR product teams to execute specific product-related projects and ensure alignment with overall market access strategies.Cross-Functional Collaboration: Work closely with cross-functional teams including medical affairs, clinical, regulatory, biostatistics, epidemiology and commercial to integrate HTA and RWE insights into broader business strategies.Strategic Planning: Contribute to the strategic planning of market access initiatives, ensuring that HTA and RWE considerations are embedded in product development and lifecycle management.Reporting and Analysis: Provide analysis and reports on HTA and RWE landscape, including competitor activities and emerging trends, to inform decision-making processes.Compliance and Best Practices: Ensure compliance with regulatory standards and best practices in all aspects of HTA submissions and RWE studies.Qualifications:Significant experience (at least 10 years) in HTA and RWE, with significant exposure to healthcare systems in international markets.Expertise in HTA and RWE: In-depth understanding of HTA processes, methodologies, and regulations worldwide, along with experience in designing and conducting RWE studies.Analytical Skills: Strong analytical and critical thinking skills to interpret complex methodologies and data and provide actionable insights.Communication Skills: Excellent verbal and written communication skills to effectively articulate insights and strategies to diverse audiences, including internal stakeholders and external partners.Stakeholder Engagement: Experience in engaging with key external stakeholders, including HTA agencies and payers, and understanding their requirements and expectations.Strategic Vision: Ability to think strategically and develop long-term plans that align with business objectives, while being adaptable to changing market dynamics.Mentoring skills, with a focus on developing team capabilities and fostering a collaborative work environment.Education: An advanced degree in Health Economics, Public Health, or a related field is required.Are you interested in this exciting opportunity? We are looking forward to receiving your online application. About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
We are currently looking for a Chemist Development to join us on a 1-year contract at our site in St. Gallen. In this position you will be directly reporting to a Process Development Chemist Team Lead and be responsible for the development of synthetic organic chemistry for transfer into pharmaceutical production. Your main responsibilities will include the independent execution and documentation of syntheses and analytical tests, process development and production support for existing and new products as well as qualification and maintenance of laboratory equipment.Key TasksIndependent planning, execution, documentation and reporting of small development projectsRepresentation of the entire department in cross-departmental project groupsIndependent synthesis, characterization and documentation of synthesis of small organic molecules in lab and pilot scaleFeedback to the laboratory manager / Group Lead MSAT in the event of unexpected observations during execution of experimentsPerforming qualification of laboratory equipment (execution and documentation)Carrying out work in accordance with cGMP regulationsMaintaining laboratory quality systems and records of synthetic protocols and analytical resultsWorking in accordance with health and the environment requirementsOrganizing routine maintenance of laboratory equipment and procurement of consumablesSubject matter expert for internal and external partners and for on-site inspectionsCreation and revision of laboratory test proceduresYour ProfileCompleted apprenticeship as a laboratory technician (EFZ) or comparable education with > 8 years professional experience orBachelor's degree in chemistry with 3-5 years professional experience orMaster's degree in chemistry or comparable fieldExperience in drafting reports and presentations for internal and external stakeholdersExperience with organic synthesis and optimization of reactions, knowledge in design of experiments and cGMP as well as process transfer and scale-up is preferred.Experience with HPLC, GC and other instrumental analyticsDiligent and independent person with the desire to do hands-on chemistry in the laboratory and evaluate the results.Team player motivated to engage with multidisciplinary teamsBusiness fluent in English and B level German.Excellent computer skills (e.g. MS Office, especially Excel; tiamoTM, Revvity Signals Notebook)Are you interested in this exciting opportunity? We are looking forward to receiving your online application. About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
Are you seeking an exciting opportunity in drug discovery research? Join our team of motivated and collaborative scientists at CSL Global Research, located in the vibrant research hub of Zurich BIO-TECHNOPARK Schlieren. As a Senior Scientist: Rare Renal Diseases / Complex Cellular Models, you will conduct research to deepen our understanding of disease mechanisms. You'll develop cutting-edge human cellular models to validate therapeutic targets and drive projects with the aim of expanding our portfolio of renal disease assets from early discovery through clinical stages. You will be directly reporting to the Head of Cellular Pharmacology & Imaging Zurich.We offer a flexible working model that balances on-site and home office arrangements, while highly encouraging on-site presence to foster collaboration, innovation, and ensure smooth lab operations. We welcome applications from candidates passionate about innovation, teamwork, and improving the lives of patients with rare renal diseases.Responsibilities:Working together with and providing expertise to research project teams in order to achieve specified research project objectives within defined time parameters.Conception of new research projects to contribute to the CSL drug discovery portfolio in the area of rare renal diseases like polycystic kidney disease.Providing scientific guidance to lab technicians and scientists developing in vitro cellular models, including hands-on lab work in establishing novel and complex methods and technologies.Planning, executing, and analyzing in vitro preclinical pharmacology experiments at the highest levels of scientific integrity.Managing external collaborations with CROs and academic collaborators to deliver data at the highest levels of scientific integrity.Providing preclinical research expert input to late-stage development and marketed drugs.Supporting business development activities by providing preclinical research expertise in the process of due-diligence of in-licensing opportunities.Continuous adequate further training.Compliance with technical, organizational and staff safety measures.Qualifications:PhD and/or MD degree in life sciences.At least 2 years of postdoctoral research experience in industrial or academic setting with a focus in renal or cardiovascular disease areas.A proven scientific impact on innovation through a solid publication track record.Deep knowledge of kidney physiology and pathophysiology of kidney polycystic disease.Strong hands-on experience in developing and executing complex cellular renal disease models, hands-on experience with human iPSC-derived models is a plus.Strong hands-on experience in a wide range of biochemical, imaging and genome editing methods and technologies to unravel complex molecular signaling pathways.Experience in designing and interpreting in vivo pharmacology experiments.Knowledge and routine application of relevant statistical methods for data analysis.Confident use of collaboration and scientific IT software.Highly effective verbal and written communication skills in English language.Ability to effectively interact with people in a dynamic matrix environment, both internally and externally.Strong commitment to quality, accuracy, and technical details.Excellent organizational and time management skills and independence in execution of tasks.Innovative, entrepreneurial attitude with a solution-oriented and pro-active work style.Are you interested in this exciting opportunity? We are looking forward to your online application. About CSL: CSL 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 is committed to delivering medicines that improve their lives. With operations in 35+ nations and approximately 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies. About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
The Global Regulatory CTA Therapeutic Area Lead is a recognized SME in CTA and is responsible for the global management of Clinical Trial Authorizations (CTAs) with the view to obtain CTA approvals in the fastest and most efficient way while ensuring quality documentation. The Senior GRSL develops the CTA submission strategy of large and/or complex projects, provides regulatory project management of CTAs and oversees the CTA submissions.This role is responsible for developing, maintaining and improving processes, drive development and improvement of new systems, solutions and procedures related to CTA activities and ensure compliance with international regulatory requirements and internal CTA procedures.The Senior GRSL supports Global Regulatory Affairs (GRA) vision of excellence regarding CTA activities for assigned projects through strategy, good scientific practice, integrity and consistent compliance with local regulatory standards.Interface with GRA TA leads and Clinical Development Operations Clinical Program Managers, Global Clinical Operations TA Leads to manage assigned product/projects and resolve cross-functional issues.Coaches and trains lower level professionals through sharing of lessons learned, staying ahead of new CTA and regulatory trends and participate to opinion sharing as CTA experts in trade association in collaboration with the Global Regulatory Intelligence and Policy (GRIP) team.Responsibilities and accountabilities:Lead CTA activities for large and/or complex clinical trials during the entire study lifecycle: develop overall CTA concept and provide CTA strategic inputs during GRA TA meetings, SET meetings, GRAST meetings and during meetings with CROEnsure all CTA regulatory activities are in alignment with the strategic direction of the GRA TA, GRAST and the SETTranslate the CTA strategy into a plan and is responsible for executing the planLiaise with other GRA functions as well as with key functions within Clinical Development Operations, GCSP, Clinical Trial Supply, Legal and CRO to ensure CTA process is performed on time and with high quality documentsDisseminate the CTA project status like CTA submission, CTA approval, CA questions to the concerned stakeholdersContribute to and/or review key documents such as, but not limited to CSP, IB, IMPD, IMP labels, DSURManage interactions with Health Authorities and is the primary contact point with regulatory authorities for communications relating to direct submissions of CTAsEnsure accurate and timely tracking and archiving of CTA activities in the CSL systemsAnticipate regulatory trends related to clinical trial applications to develop regulatory Intelligence capabilities and share lessons learned to ensure development of a first in class study strategyCoaches and trains Global Regulatory Clinical Study Leads and SpecialistsDevelop, maintain and improve CTA processes, drive development and improvement of new systems, solutions and procedures related to CTA activities:Be a Subject Matter Expert for CTA related topics and ensure continuous process improvementResponsible for the generation, maintenance and provision of metrics on workload as well as KPIs for key CTA activities and analyze consolidated dataSupport budget development and workload planning related to CTA activitiesEducation:Advanced degree (MSc, PhD or equivalent) in life science, pharmacy, or other health/medical related area preferred)Other degrees and certifications considered if commensurate with related regulatory or clinical research experience.Experience:As a guide, a minimum of 7+ years' experience in managing Clinical Trial and Clinical Trial ApplicationsExperience Working with or Working within a Contract Research Organization, preferredBroad knowledge of regulatory requirements in key markets for obtaining Clinical Trial AuthorizationsExperience in automation of CTA processes, knowledge in automated and tech driven processesExperience in developing KPI for CTA-related activitiesExperience in vaccines would be idealKnowledge of ICH guidelines/GCP, EU CTA regulation (CTR536/2014), related regulatory guidelines and experience in scientific/medical researchDemonstrated sound judgment and flexible approach to managing situationsCustomer service focusStrategic and tactical thinking ability, complemented by a "hands on" operational approach and business planning orientationAbility to identify the 'big picture' and opportunities/major issues and link day to day tasks with long term goalsDemonstrated ability to deal with rapid changeProven ability to deliver to successful outcomes to internal and external customers while meeting business objectives About CSL Vifor CSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!
