Director, Global Labeling Data Strategy Lead

vor 2 Wochen

Bern, Schweiz CSL Behring Vollzeit

As a member of the GL leadership team, the director, GL data strategy and team assess and communicate the impact of key clinical endpoints on a future label. You will influence by articulating how agency advice and precedence and the competitive landscape support or require modifications to the design to deliver desired label outcomes. The position then maps the future label to potential advertising and promotion opportunities and tracks impact of recommendations to successful product promotion. Additionally, this position may identify labeling claims that could result from a proposed protocol. Assessment must occur early in product development activities and before endorsement of the pivotal protocol. Keeping the end in mind, impact analysis should include: analysis of endpoints, inclusion criteria, exclusion criteria, major market and key secondary market regulatory precedence and standard of care, experience gathered from other internal programs and HA requests for information along with experience gathered from competitors. The output can inform GL Strategists, Regulatory (global and region), Commercial and Clinical stakeholders regarding the trade-offs between the proposed protocol design and impact on labeling prior to committing to a protocol design and/or early development labeling strategy. For key marketed products, the director, GL data strategy/team identifies potential ways to leverage existing data to improve product differentiation based on regulatory and business goals. Using established methodology and tools, the data strategy team has the potential to also support response generation for other GRA strategic questions as requested by GRAST/GRALT. This position provides leadership, coaching, innovation and technical expertise, a keen understanding of country-specific regulatory requirements and the ability to connect data with strategy to meet company objectives. Main Accountabilities and responsibilties: - Lead data strategy assessment team across all TAs and put in place an E2E product information strategy during entire lifecycle. - Assess the impact of key endpoints on label using competitive intelligence and data analysis, regulatory precedence and knowledge of study design, development and trial conduct. - Utilize findings to make recommendations which inform sound decisions when developing labeling and/or regulatory strategies. - Create a natural linkage to global ad promo. - Liaise with GRA Regions, commercial development and commercial ops to ensure appropriate regulatory review of core product material and local ad promo review process and system/tools. - Use creative problem-solving and facilitate communication to key stakeholders by clearly explaining the science/regulatory perspective. - Act as a resource across GRA to provide insight for challenging questions based on established and proven methodology. - Build technology solutions that power future analysis and provides support across GRA through use of tools and established methodology. Qualifications and Experience: - University degree (4 year degree) in Life Sciences or Data Analysis; advance degree preferred. - Minimum of 12 years of biotech/pharmaceutical industry experience or a combination of 5+year’s experience in regulatoyr and/or related data analysis or clinical development experience

**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 leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

  • Associate Director, Global Feasibility

    Vor 2 Tagen

    Bern, Bern, Schweiz CSL Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start-up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Associate Director, Global Feasibility

    vor 3 Stunden

    Bern, Bern, Schweiz CSL Vollzeit

    Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start up delivery. The role is made for a dynamic candidate with outstanding analytical skills and an easy way to communicate the data in a recommended feasibility strategy to...

  • Global Process Engineering Director

    vor 2 Stunden

    Bern, Bern, Schweiz Recrutis Vollzeit

    This is an exciting opportunity for a highly skilled Global Process Engineering Director to lead our client's Upstream Process Technology department. As a key member of the Global Manufacturing Sciences team, you will be responsible for overseeing all USP Process Transfer & Sciences activities, including coordination of technical and laboratory activities in...

  • Global Data Governance Manager

    vor 2 Wochen

    Bern, Schweiz Robert Walters Vollzeit

    A rewarding Global Data Governance Manager position has become available at a leading firm in their field.Responsibilities:Lead comprehensive Data and Change Management projects, focusing on areas such as Data Governance, Master Data Management (MDM), and Data Quality.Take ownership of developing and executing the strategy and design for the steering model...

  • Global Data Governance Manager

    vor 1 Woche

    Bern, Bern, Schweiz Robert Walters Vollzeit

    Salary: confidentielA rewarding Global Data Governance Manager position has become available at a leading firm in their field.Responsibilities:Lead comprehensive Data and Change Management projects, focusing on areas such as Data Governance, Master Data Management (MDM), and Data QualityTake ownership of developing and executing the strategy and design for...

  • Director of Global Study Planning

    Vor 2 Tagen

    Bern, Bern, Schweiz CSL Vollzeit

    Job Description:The Associate Director, Global Feasibility plays a critical role in the end-to-end feasibility and study start-up delivery process. This dynamic role requires outstanding analytical skills and the ability to communicate data-driven recommendations to stakeholders and governance.Main Responsibilities:Develop strategic insights on protocol and...

  • Project Manager Data Strategy

    vor 2 Wochen

    Bern, Schweiz ITech Consult Vollzeit

    **Project / Role**: For our client we are looking for an experienced Project Manager Data Strategy with a workload of 20-25%. In this role you will be responsible for the development of the strategy as well as the formulation of ambitions for the handling of data in a Swiss federal authority. Main tasks: - Development and implementation of data...

  • Director, Sr. Global Regulatory Lead, Hematology Ta

    vor 3 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    **Position Purpose**: The Dir., Sr. Global Regulatory Lead, Hematology TA, is a member of a GRA GPS Therapeutic Area and contributes to the vision and goals for Global Regulatory Affairs (GRA) as: - ** GRA** Representatives** **on Product/Project Strategy Teams (PSTs), key Delivery Teams (e.g., Clinical Development Teams [CDTs], Safety Management Teams...

  • Data Strategy Consultant

    vor 2 Wochen

    Bern, Schweiz dataroots Vollzeit

    **The Job**: As a Data Strategy Consultant you form the bridge between the business and the data team: you help translate the ambitions of management to concrete data & AI-driven initiatives, you collect business requirements from the client and identify the data to enable the engineers to build and deploy effective models. You help translate the outcome...

  • Associate Director, Global Critical Safety Systems

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    The Associate Director, Global Critical Safety Systems is accountable for development, deployment and governance of core technical environment, health and safety (EHS) processes and standards across all CSL/Seqirus units. You will help ensure global program understanding, and implementation. You will collaborate as part of the Global EHS team, reporting into...

  • Associate Director, Global EHS Manufacturing

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    The role of the Associate Director, Global EHS Manufacturing is to** **develop and implement programs and plans to manage EHS risks associated with manufacturing operations. Ensuring compliance with laws, regulations and company policies. Specialized focus on development, deployment and support of core technical EHS processes and standards. You will...

  • Senior Strategic Sourcing Director

    Vor 2 Tagen

    Bern, Bern, Schweiz CSL Plasma Inc. Vollzeit

    CSL Plasma Inc. is seeking a Senior Strategic Sourcing Director to lead the development and execution of sourcing strategies for our Information Technology (IT) and Technology categories.About the Role:This is an exciting opportunity for a highly experienced strategic sourcing professional to join our team and contribute to driving business success. As a...

  • Consultant - Strategy, Digital, Data & Technology

    vor 2 Wochen

    Bern, Schweiz Two Circles Vollzeit

    We are Two Circles, the four-time Sport Industry Agency of the Year, and we are a data-driven sports marketing agency. Working as consultants for a 150-strong client base that currently includes the Premier League, IOC, ECB, UEFA and Wimbledon, we grow direct relationships with fans to drive business growth. And we do it by using data, helping them better...

  • Ass. Director, GRA Regional TA Lead

    vor 2 Wochen

    Wohlen bei Bern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Ass. Director, GRA Regional TA Lead, BernClient: CSLLocation: SwitzerlandJob Category: OtherJob Reference: 8e2509f9a93cJob Views: 3Posted: 14.03.2025Expiry Date: 28.04.2025Job Description:Job Purpose:We are looking for an experienced TA Lead/Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental...

  • Director, Epidemiology

    vor 1 Woche

    Bern, Schweiz CSL Behring Vollzeit

    **Position Purpose**: The Director, Clinical Epidemiology is responsible for leading epidemiological activities for assigned products across therapeutic areas within Clinical Research & Development to facilitate robust, evidence-based decision making. The role proactively identifies the need for epidemiology evidence, and develops and executes research...

  • Senior Manager, Feasibility and Operations

    Vor 2 Tagen

    Bern, Bern, Schweiz CSL Vollzeit

    About the Role:The Associate Director, Global Feasibility is responsible for developing a feasibility strategy across clinical programs and delivering its end-to-end process. This involves collaborating with internal functional area leads and external service providers to build knowledge on study and country interest and feasibility.Main...

  • Lead Counsel Regulatory, Safety

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    **Purpose**: Lead counsel responsible for providing and coordinating specialist legal advice on safety and pharmacovigilance matters in CSL’s key jurisdictions, and strategic and specialist legal advice on regulatory matters. **Responsibilities**: - Provide specialist legal advice to CSL’s Global Regulatory Affairs (GRA) and Global Clinical Safety &...

  • Data Architect

    vor 2 Wochen

    Bern, Schweiz Data Pros Recruitment GmbH Vollzeit

    This is your chance to join a well respectable Swiss company and play a key role in their digital space. The company is amidst major change in becoming more data driven and you will be able to stamp your presence in this autonomous role in the data management area. Aufgaben Supporting their large group of data analysts and data scientists, your key...

  • Associate Director, Strategic Feasibility

    Vor 2 Tagen

    Bern, Bern, Schweiz CSL Vollzeit

    Job Summary:We are seeking an experienced Associate Director, Global Feasibility to join our team. As a key member of our clinical operations department, you will play a critical role in the end-to-end feasibility and study start-up delivery process.Main Responsibilities:Develop and implement a feasibility strategy across clinical programs.Collaborate with...

  • Executive Director, Business Development

    vor 2 Wochen

    Bern, Schweiz Emmes Global Vollzeit

    Overview: **Executive Director, Business Development** **Switzerland Remote** Emmes Group: Building a better future for us all. Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary...