Biomarker Clinical Operations Lead In Pdg
vor 22 Stunden
Biomarker Clinical Operations Lead in PDG For our client, a leading pharmaceutical company in Basel, we are looking for a new team member as Biomarker Clinical Operations Lead in PDG The Biomarker Clinical Operations Lead in Product Development Global Clinical Operations (PDG) is responsible and accountable to provide BIOMARKER OPERATIONAL EXPERTISE by planning, coordinating, and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data, for PDG clinical studies. Your Tasks & Responsibilities: Provide biomarker/IVD operational expertise to clinical study teams to ensure operational feasibility and quality data delivery Be accountable for the development of the BIOMARKER MANAGEMENT PLAN and the execution of deliverables for assigned drug and device studies (e.G. IVD clinical performance studies) in partnership with the Clinical Study Lead or designee Manage all study level biomarker operations activities for both clinical (i.E. drug) and IVD studies (e.G. manage vendor/testing sites, ICF/protocol input, eTMF/RACT set-up, sample/data flow, data quality and transfer set-up) Partner with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, shipping conditions and logistics for biomarker samples Lead identification, selection and oversight of BIOMARKER VENDORS, including development and oversight of scope of work, budget, ensuring quality delivery and performance Actively partner with Data Management to oversee and coordinate biomarker data format and delivery timelines COLLABORATE AND PARTNER with cross functional stakeholders (e.G. study team members, biomarker science, CDx, procurement, testing site monitors, diagnostic partners, central lab) to execute biomarker/IVD operational strategies, serving as a single point of contact for biomarker/IVD operations on multiple study teams Provide technical knowledge of aspects related to biomarker analyses (e.G. sample collection and handling, assay, device and imaging technologies) Develop and oversee biomarker analysis TIMELINES, BUDGET, RISK, COMPLIANCE and QUALITY, ensuring adherence to ICH/GCP, SOPs, ISO 20916 and regulatory requirements Attend operations team meetings and investigator/monitor meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection, handling and IVD procedures Provide responses to biomarker sample/IVD related questions or issues from Health Authorities IDENTIFY AREAS OF BEST PRACTICE and process improvements and contribute to/lead initiatives (if requested) You will work on business priorities as directed Expectation of ongoing and sustained onsite presence in compliance with local requirements Your Qualifications: Minimum Bachelor/Master in Life Sciences (in Scientific, Medical or Healthcare subject area). Further qualification, e.G. PhD and/or project management certification is desirable. 3+ years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment Extensive clinical development experience with evidence of working in teams running clinical studies Strong experience with vendor and project management Possess strong knowledge of drug development process and respective regulations, including ICH and GCP guidelines Have a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological samples Experience working in a global and matrix environment Excellent collaboration, communication, influencing and presentation skills Critical reasoning skills including the identification and resolution of complex problems Detail oriented with the ability to work independently and manage multiple competing priorities Fluency in English with additional language skills as an asset Please note that the latest starting date is 01.06.2025 (earlier start date preferred) Your Application: Please apply online. For further information about the position, please contact your Gi consultant, Marta Castellano , MSc Biochemistry ( ; +41 76 342 57 90). Seniority level Associate Employment type Temporary Job function Manufacturing Pharmaceutical Manufacturing #J-18808-Ljbffr
-
Biomarker Clinical Operations Lead in PDG
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Work Selection AG VollzeitWork Selection AGWe are looking for a motivated and committed Biomarker Clinical Operations Lead in PDG for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a 12 month assignment with the option to extend.The Biomarker Clinical Operations Lead (Biomarker Operations Project Manager accountable) in PDG at Roche/Genentech is responsible and accountable...
-
Biomarker Clinical Operations Lead
vor 22 Stunden
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions AG VollzeitBiomarker Clinical Operations Lead (6350)CTC is a specialized industry expert in sourcing top talent and providing reliable HR and consulting services. We support candidates in finding promising career opportunities and offer cutting-edge skill development training programs.About Our ClientOur client is a global leader in drug discovery and development and a...
-
Biomarker Operations Project Lead
vor 16 Stunden
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions AG VollzeitThe ideal candidate will have a solid background in clinical research, laboratory settings, or pharmaceutical/biotechnology R&D environments. Strong experience in clinical development, project management, and vendor management is essential.Key Responsibilities:Plan, coordinate, and oversee biomarker operations for PDG clinical studies.Manage biomarker...
-
Senior Clinical Operations Manager
vor 16 Stunden
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions AG VollzeitCTC Resourcing Solutions AG supports pharmaceutical companies in their search for top talent. We are proud to present an exciting opportunity for a Biomarker Clinical Operations Lead.About Our ClientWe work with a global leader in drug discovery and development, known for its innovation and impact in the field of personalized healthcare. With a strong focus...
-
Pharmaceutical Operations Specialist
vor 16 Stunden
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions AG VollzeitWe are seeking a highly motivated Biomarker Clinical Operations Lead to join our client's Pharma Product Development Global Clinical Operations department. This is a mid-senior level, full-time position in Basel.In this role, you will provide biomarker operational expertise by planning, coordinating, and overseeing all operational activities related to...
-
Clinical Research Operations Lead
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Coopers Group GmbH VollzeitJob Description:We are looking for a highly skilled Biomarker Clinical Operations Lead to join our team in Basel. As a key member of our operations team, you will be responsible for providing operational expertise to clinical study teams, ensuring the feasibility and quality of biomarker data delivery.Your Key Responsibilities:Develop and implement the...
-
Senior Clinical Operations Leader
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Thermo Fisher Scientific VollzeitAbout the Opportunity:We are seeking an experienced Senior Clinical Operations Leader to lead and drive the delivery of our Neurology Portfolio. As a key member of the Roche / Genentech Pharma Product Development Global Clinical Operations team, you will be responsible for developing and refining the strategy for our Neurology programs and studies.Key...
-
Biomarker Operations Specialist
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Coopers Group GmbH VollzeitAbout Coopers Group GmbHCoopers Group GmbH is a leading provider of biomedical services, committed to delivering high-quality results and exceptional client experiences.Job Summary:We are seeking an experienced Biomarker Clinical Operations Lead to join our team in Basel. This role will be responsible for providing operational expertise to clinical study...
-
Lead Biomedical Operations Expert
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Coopers Group GmbH VollzeitBiomarker Clinical Operations LeadWe are seeking an experienced Biomarker Clinical Operations Lead to join our team in Basel. As a key member of our operations team, you will be responsible for providing operational expertise to clinical study teams, ensuring the feasibility and quality of biomarker data delivery.Your Key Responsibilities:Develop and...
-
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitAbout the RoleAt Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are committed to transforming drug development and realizing our Pharma Ambition to deliver innovative medicines addressing diseases with high societal impact. We seek a highly skilled Clinical Operations Therapeutic Area Leader to lead and drive the delivery of...
-
Clinical Operations Therapeutic Area Strategist
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitWe are looking for a Clinical Operations Therapeutic Area Leader to lead and drive the delivery of our Neurology Portfolio. This senior people leadership position holds significant accountability for clinical operations strategy and execution as well as enterprise collaboration.The successful candidate will be responsible for developing and refining the...
-
Clinical Operations Therapeutic Area Leader
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitThe PositionAt Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. We are looking for a Clinical Operations Therapeutic Area Leader to lead and drive the...
-
Clinical Operations Therapeutic Area Leader
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitThe PositionAt Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. We are looking for a Clinical Operations Therapeutic Area Leader to lead and drive the...
-
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitAbout the JobOur team is dedicated to improving patients' lives through novel medicines that have a meaningful impact. We are looking for a highly skilled Clinical Operations Therapeutic Area Leader to join our team and drive the delivery of our Immunology Portfolio.In this role, you will be responsible for developing and refining our Immunology Portfolio...
-
Global Clinical Operations Director
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitAs a member of the Roche Group, we are committed to transforming drug development and realizing our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029.We are looking for a Clinical Operations Therapeutic Area Leader to lead and drive the delivery of our Neurology Portfolio, who will be...
-
Clinical Operations Therapeutic Area Leader
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitThe PositionAt Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. We are looking for a Clinical Operations Therapeutic Area Leader to lead and drive the...
-
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitAbout the OpportunityWe are seeking a seasoned leader to develop and refine our Immunology Portfolio Strategy, shaping and iterating the PD clinical operations strategy for Immunology. This role involves maintaining active and collaborative oversight of Immunology assets and studies, monitoring portfolio status, anticipating risks, and implementing proactive...
-
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitAbout the PositionWe are seeking a highly skilled Clinical Operations Therapeutic Area Leader to lead and drive the delivery of our Immunology Portfolio. This role involves developing and refining our Immunology Portfolio Strategy, overseeing Immunology assets and studies, and leveraging analytical tools and innovative processes to enhance clinical trial...
-
Clinical Development Manager
vor 16 Stunden
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions AG VollzeitThis is an excellent opportunity for a skilled professional to contribute to cutting-edge drug development and improve patient outcomes through innovative medicines.About Our ClientWe are partnering with a global leader in drug discovery and development, recognized for their innovation and impact in personalized healthcare. They operate across various...
-
Clinical Operations Therapeutic Area Director
Vor 4 Tagen
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitAbout the RoleWe are seeking an experienced Clinical Operations Therapeutic Area Leader to lead and drive the delivery of our Cardiovascular, Renal, and Metabolism (CVRM) Portfolio. This senior leadership position holds significant accountability for clinical operations strategy and execution as well as enterprise collaboration.As a key member of our team,...
