Director, Clinical Portfolio Execution
Vor 2 Tagen
Description
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 of Clinical Portfolio Execution? This position is located in our King of Prussia PA, Marburg Germany or Bern Switzerland office. It is a Hybrid role. You will have multiple direct reports. You will report to the Senior Director of Clinical Portfolio Execution.
Responsibilities:
You will establish and manage standards and processes for main study operations activities (e.g., clinical trial support, clinops human biological sample management).
Facilitate global resourcing for clinical portfolio execution roles to support the Head, CPE in ensuring appropriate and resource allocation aligned with project priorities. In collaboration with Business Operations, includes demand planning and utilization across all programs. Ensure there is a communication strategy laterally and vertically for resource management and utilization.
Utilize lessons learned from prior study conduct, site visits, audits, and inspections to develop and implement process improvements. Collaborate with Operational Excellence and Clinical Compliance to ensure CSL expectations adhere to ICH GCP guidelines and industry best practices. Manage framework/standardized tools that enable best practice approach.
Lead CPE capability building by supporting onboarding. Ensure Harmonization of practice at study level, to ensure consistency, high quality, and efficiency.
Set-up and make the interface with any Functional Service provider for study delivery activities. Ensure oversight of vendor activities including FSO. May contribute to train FSP staff on CSL expectations.
Responsible for quality practices, management monitoring, control documents development, improvement support and training related to Study Delivery roles People Management
Experience
A Bachelor’s degree in Science or Pharmacy.
12 or more years of relevant clinical research (or related) experience in the pharmaceutical industry.
An understanding of the drug development process, and specifically, each step within the clinical trial process.
Experience in study management, clinical-ops, human biological sample management and related process development.
Knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directives.
#LI-Hybrid
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our to see what’s available to you as a CSL employee.
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.
-
Director, Clinical Portfolio Execution
Vor 2 Tagen
Bern, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Client:CSLLocation:King of Prussia PA, Marburg Germany, or Bern Switzerland (Hybrid role)Job Category:OtherJob Reference:9a314a52d7f4Job Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people...
-
Associate Director, Global Feasibility
Vor 2 Tagen
Bern, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Associate Director, Global Feasibility, BernClient:CSLLocation:BernJob Category:OtherJob Reference:cefc70d7dbdfJob Views:8Posted:21.01.2025Expiry Date:07.03.2025Job Description:Joining CSL as Associate Director Global Feasibility offers an exciting opportunity to be part of a continually growing team dedicated to...
-
Associate Director, Global Feasibility
Vor 2 Tagen
Bern, Schweiz CSL VollzeitJoining 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...
-
Senior Director Clinical Trial Supply
Vor 2 Tagen
Bern, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Senior Director Clinical Trial Supply (m/f/x), BernClient:CSLLocation:Bern, SwitzerlandJob Category:OtherJob Reference:9b135202d537Job Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:To strengthen our Supply Chain department in Europe, we currently hire a Senior Director Clinical Trial Supply (m/w/x)...
-
Director, Operational Pricing
vor 5 Stunden
Bern, Schweiz CSL Plasma Inc. VollzeitDirector, Operational Pricing page is loadedDirector, Operational PricingApply locations EMEA, CH, Kanton Zurich, Opfikon, CSL Vifor EMEA, CH, Kanton Bern, Bern, CSL Behring time type Full time posted on Posted 2 Days Ago job requisition id R-249433Role Overview:The Director, Operational Pricing is responsible for proactive pricing management of the assigned...
-
Director, Marketing Primary Immunodeficiency
Vor 6 Tagen
Bern, Schweiz CSL Behring Vollzeit**Purpose**: The Director for Immunoglobulins (IG) Portfolio, Primary Immunodeficiency (PID), develops and implements brand and disease area strategy for the CSL Behring international (INT) region. You will be the vanguard of improving sales growth through a combination of market expansion and brand adoption strategies that align across a diverse...
-
Senior Director Regulatory Group Lead
vor 1 Tag
Bern, Schweiz CSL Plasma VollzeitCSL 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...
-
Global Clinical Quality Assurance Manager
Vor 5 Tagen
Bern, Schweiz CSL Behring VollzeitAs a CQA Manager, you will be managing Global CQA activities in the respective regions (Asia-Pacific, Americas, EMEA, Japan) and globally. Under supervision of the Regional Head CQA, you will be responsible for planning, maintenance and implementation of the assigned Global R&D Quality Audit Program with focus on Pre-Clinical, Early Clinical and Clinical...
-
Executive Director Heor
Vor 2 Tagen
Bern, Schweiz CSL Behring Vollzeit**Role Overview**: The Executive Director of Health Economics Outcomes Research (HEOR) at CSL Behring and CSL Vifor is a pivotal role responsible for leading the generation and dissemination of payer evidence across the pipeline and inline portfolio. This senior position demands deep expertise in Health Economics, Real-World Evidence (RWE), and Health...
-
Executive Director, Business Development
Vor 6 Tagen
Bern, Schweiz Emmes Global VollzeitOverview: **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...
-
Director Msit
Vor 2 Tagen
Bern, Schweiz Johnson & Johnson VollzeitJohnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure...
-
Managing Director
Vor 2 Tagen
Bern, Schweiz TN Switzerland VollzeitMorgan Philips is currently looking for a Managing Director for an international luxury hotel chain with hotels in Europe.The role consists of overseeing the Swiss properties (6 hotels) mainly in the Swiss Alps (German part).This position is ideal for a Swiss expat bringing international exposure and willing to move back home.Main...
-
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...
-
Executive Director, Business Development
Vor 5 Tagen
Bern, Schweiz Emmes VollzeitOverviewExecutive Director, Business DevelopmentSwitzerland RemoteEmmes 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 clinical research...
-
Csv Director
Vor 4 Tagen
Bern, Schweiz Hobson Prior VollzeitHobson Prior are currently looking for a CSV Director to join a brilliant organisation on a permanent basis located in Bern with the ability to work remotely from home. Our client is focused on utilising their state-of-the-art manufacturing facilities meet global regulatory requirements and employ the latest disposable production technologies, allowing...
-
Director, Global Labeling Data Strategy Lead
Vor 5 Tagen
Bern, Schweiz CSL Behring VollzeitAs 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...
-
Manager, Feasibility
Vor 3 Tagen
Bern, Schweiz CSL Behring VollzeitSummary: The Manager, Feasibility & Recruitment Strategy within the Clinical Development Operation; Global Feasibility and Start-up group is responsible for feasibility mobilization, country and site feasibility as well as enrollment planning activities in support of the Clinical studies. This position will oversee the framework for ensuring study planning...
-
Director, L&d, E2e/emea
Vor 7 Tagen
Bern, Schweiz CSL Behring VollzeitDescription: This position is responsible for creating business function learning strategies, and leading, developing, executing and measuring development solutions that drive learning outcomes and strengthen CSL’s ability to attract, develop and retain the best talent. The person in this role will also be responsible for leading global components of the...
-
Director, Head Value Stream Packaging
Vor 5 Tagen
Bern, Schweiz CSL Behring VollzeitCSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1800 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide. For our Bern site, we are currently looking for a new **Director, Head Value Stream Packaging (f/m/d)**: As a successful Director,...
-
Director, Finance BP
Vor 2 Tagen
Bern, Schweiz CSL VollzeitThe Opportunity: Reporting to the Vice President, R&D Finance and Business Planning & Evaluation, as the Director, Finance BP - Alliances & Post Deal Management , you will have a number of external strategic alliances with external parties that are often driven through business development and licensing activities. You will provide finance support...