Experience

Onward Therapeutics

• Switzerland
• Biotechnology Research
• 1 - 100 Employee

• Director Clinical Operations

  • Jun 2023 - Present

  Responsible for the operational management and the oversight of clinical trials in Oncology, from the protocol concept through the clinical study report, ensuring completion of study deliverables Responsible for the operational management and the oversight of clinical trials in Oncology, from the protocol concept through the clinical study report, ensuring completion of study deliverables



OSE Immunotherapeutics

• France
• Biotechnology Research
• 1 - 100 Employee

• Clinical Project Director - Early phase studies / Immuno-onco

  • Mar 2021 - Present

  . Overall management of the planning and conduct of early phase clinical trial. . Budget Management . Vendor Management (set up bid defense meeting, selection, governance meeting) -Internal coordination of the clinical study: management of regular meeting with the study core team (scientific, statistician, data manager, study product manager, CMC department, nonclinical department) and action plan follow-up - Lead, manage, and give direction to the project team members for ensuring that goals and objectives of the project are reached within defined time frame, quality., - Coordinates the writing of Clinical Study Report (CSR). - Mock inspection preparation, participation, and collaboration to CAPA Follow up - Early access program management (CRO, exploitant selection and coordination) Show less



Ipsen

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Operation Manager, Global Med affairs /Clin Ops

  • Nov 2019 - Oct 2020

  Accountable for planning and execution of interventional studies and NIS (Retro and prospective studies, survey, RWE study), oversee CRO. Manage the development and performance of the Clinical Project team (10 CPM+CRA) based in France and Spain. To assess the need, recruit, manage, train, review, develop, set objectives and assess performance of Clinical Project Manager (CPM) and CRA in collaboration with the head of GMA Clinical Operations Participation to BID defense meeting and drive CRO selection in collaboration with Medical TA head, Global Buyer. Participation to CRO operational governance meeting Show less



Enterome

• France
• Biotechnology
• 1 - 100 Employee

• Head of Clinical Operations

  • Apr 2018 - Oct 2019

  Key area responsibility as Head of Clinical Operation: - Overall management of the planning and conduct of clinical and translational studies. - Management of study team (1 study coordinator and 2 Clinical Project Manager) - RFP writing / Set up Bid defence meeting and drive CRO selection in collaboration with Medical - Participate in the budget negotiation process and finalization with key contractors - Vendor Management (quotation/budget discussion, SOW review and activities overseeing) - Accountable of study Feasibility and country commitment - Participation at the briefing book preparation for scientific advice (PEI, FDA) - Writing/Review of Standard Operating Procedures and Key Performance Indicators Key area responsibility as International Clinical Project Manager (US and EU) : • International Early development study: Crohn Disease, Glioblastoma • International exploratory study : IBD - Participation to the exploratory study design to ensure the conformity with methodological/ ethical aspects and RGPD requirement. - Preparation of study regulatory documents, submission to / discussion with Competent Authorities and EC - Management of internal coordination of the clinical study: management of regular meeting with the study core team and action plan follow-up - Coordination and participation to the writing and/or validation of the study documents (Protocol, Subject con-sent form, Investigator’s Brochure, Clinical Study Report according to ICH GCP) - Oversee quality and progress of the study to ensure delivery on time and in line with budget - Operational, data-management and statistical documents review and validation (CRF, DMP, SAP) - Supervision of monitoring, validation of monitoring plan and monitoring reports - Management of drug/products and material supplies in collaboration with CMC team. - Organization of biological sample shipment, supervision of analytical labs - Preparation and maintenance of the Trial Master File Show less



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Development feasibility Manager

  • Apr 2017 - Apr 2018

  Develop and sustain the local investigator landscape in line with the Global Development pipeline to support strategic global study design and excellence in clinical trial delivery. - Management of local feasibility ( Oncology, cardiology, Inflammatory) - Drive Targeted local feasibility - Deliver local information into study design planning - Identify and contract with Reference Sites in support of local landscaping - Drive local patient recruitment and retention strategies Show less

• Regional clinical trial manager (EU, Middle East)

  • Jan 2015 - Apr 2017

  Lead and manage the conduct of clinical trials across multiple countries ( South EU, Middle East)Key areas of Responsibility:•Supports country-level operational planning and site selection within region•Contributes to site-level goal setting and study-specific deliverables for clinical sites within their region •Coordinates cross-functional review of issues escalated directly from sites or via the CRA and facilitates resolution •Oversight and monitoring of applicable vendor activities e.g. laboratories and equipment provisioning•Contribute to development of study-specific materials –e.g. monitoring plan, study specific training documents•Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training•Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g. vendor management•Execute regulatory agency inspection readiness activities (e.g. TMF review, story board generation) within region•Contribute to study-level investigational product management •Monitor the execution of the clinical study against timelines, deliverables, and budget, across multiple countries •Review Monitoring Visit Reports Show less

• Clinical Project Manager at AMGEN

  • Jun 2008 - Jan 2015

  Clinical Research Projects and therapeutic area experience:• International First in Human study : Inflamatory disease• International early phase 1b study : Oncology : solid tumour and Paediatric LALKey areas of Responsibility:- Initiate and coordinate feasibility assessment, potential investigator identification- Review and approve monitoring reports- Ensures all study staff understand study deliverables and timelines (Lead local TC)- International Investigator meeting: Presentation of Monitoring expectation - Support to the write of Monitoring plan for centralized monitoring- Study communication plans and local recruitment strategies - Local team meetings and liaise with global study team- Management of study team Show less



Quintiles

• Spain

• Clinical trial leader

  • Jan 2006 - Jun 2008

  Clinical Monitoring and local coordination of 13 centres Central points of communication for all site related issues Coordinate amendment submission to the Ethic committee Clinical Monitoring and local coordination of 13 centres Central points of communication for all site related issues Coordinate amendment submission to the Ethic committee


AstraZeneca
• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee
• CRA

  • Jan 2003 - 2006