Claire Gaultier
Program Director, ACLF at GENFIT- Claim this Profile
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English Full professional proficiency
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French Native or bilingual proficiency
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German Limited working proficiency
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Spanish Elementary proficiency
Topline Score
Bio
Credentials
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ABPI certified
The Association of the British Pharmaceutical Industry (ABPI)Jan, 2015- Nov, 2024 -
Lean Six Sigma Black Belt
International Six Sigma InstituteJan, 2014- Nov, 2024 -
PRINCE2
APMG-InternationalSep, 2010- Nov, 2024 -
Formation a l'experimentation animale ; Niveau I
Veterinary Colleges - FranceJun, 2004- Nov, 2024
Experience
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GENFIT
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France
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Biotechnology
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100 - 200 Employee
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Program Director, ACLF
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Jan 2020 - Present
Responsible for the planning and delivery of the Acute on Chronic Liver failure program Responsible for the planning and delivery of the Acute on Chronic Liver failure program
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NEAT ID Foundation
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Belgium
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Programme director
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Jul 2018 - Apr 2019
NEAT ID is a Brussels-based research network delivering HIV research projects since 2012. In 2018 NEAT ID entered a new phase by independently sponsoring its first trials and formed a dedicated CRO to run their execution. In this context, my role was two-fold: • Clinical operations continuity (CRO): Ensure revenues continuity by setting up the first trials on behalf of the new CRO from scratch (trial sites agreements, PMO, CRO services) and supporting the creation of the project team over 6 months. Provided direction to the line management on operational delivery for all clinical projects. Participated in the development of long and short term objectives for the CRO • Project portfolio sponsorship : Set up NEAT ID as trials sponsor in EU countries and delineated its responsibilities. Interfaced with the network of KOLs, existing and potential founders and the regulating bodies pan EU, while working towards creating a proprietary EU HIV clinical database as well as sites database • Steered the NEAT ID network and its executives to identify organizational priorities in core domains: Communication, Innovation management, Operational delivery, Strategic direction, governance
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Medical Affairs Strategy and Operations manager, Rare Diseases Unit
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Mar 2017 - Jul 2018
I worked as a medical operations manager for the rare diseases unit until its handover to Orchard therapeutics in 2018. Therapeutic areas included PAH (pulmonary arterial hypertension) and Amyloidosis - Enabled the development and implementation of the global medical affairs plans for the Rare diseases assets in alignment with the clinical, market access and commercial strategies. - Developed and managed departmental performance metrics - Interfaced with other departments to design cross-functional process efficiencies - Oversight of project medical budgets - Ensured that: Internal and external presentations enhance the medical knowledge of development projects and marketed products, marketing functions have appropriate medical scientific support, product and development project information is up to date based on external publications
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Chelsea and Westminster Hospital NHS Foundation Trust
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United Kingdom
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Hospitals and Health Care
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700 & Above Employee
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Senior clinical operations Manager, HIV
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Apr 2015 - Mar 2017
Managed clinical trial operations in the field of HIV for St Stephens clinical research, CRO spun out of NHS and executing research on behalf of the SSAT Trust (Sponsor) April 2015 - November 2015: Focused on redynamising a phase 3 project sponsored by NEAT ID and ViiV May 2016-March 2017: Focused on accelerating a phase 4 research study funded by Gilead Responsibilities included: - oversight for resourcing, budget, maintenance of high quality standards, training and mentoring of clinical operations employees as well as the activities of local freelance associates. - Ensuring audit preparedness of Clinical trials, including master files, training records, processes, and SOP compliance - Participating in CRO budget activities, optimizing profitability of the projects SSAT ceased to exist on 2018 and sponsorship responsibilities over ongoing research trials were transferred to the NEAT ID foundation
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Kinapse
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United Kingdom
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Consultant, life sciences
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Nov 2015 - May 2016
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3H Partners
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United Kingdom
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Business Consulting and Services
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1 - 100 Employee
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strategy consultant (Independent consultant)
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Aug 2014 - Apr 2015
I worked on several short strategy projects to expand the team's capabilities and subject matter expertise in HCP/KOL networks and pharmaceutical research management. I particularly enjoyed: • Piloting an innovative medical engagement project for a top-tier Pharma company (French affiliate) | Paris. Led a clinical research capabilities audit work stream: conducted organizational and financial assessments of public and private oncology research units, and identified training, processes and organizational steps needed to progress centres along the clinical research ladder. The initiative expanded the Client’s access to French KOLs and oncology units by providing unique independent recommendations • Proposing a roadmap for the creation of the Clinical Research Unit of the largest private hospitals Group in France | Paris I conducted audits of the research units and research capabilities of each of the private hospitals on core therapeutic areas, and analysed the sites data to represent and measure their research activity within the group. My conclusion and recommendation was that a centralised research structure would create synergies among the sites and value for the group
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Bill & Melinda Gates Foundation
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United States
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Non-profit Organizations
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700 & Above Employee
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Associate program officer, Global Health contractor
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Sep 2013 - Mar 2014
IP with a-connect. Manage projects and cross-cutting efforts to support the Global Health (GH) product development strategy with a focus on the clinical research component of development, driving effective management of the Global Health Clinical Consortium, facilitating communications with internal and external stakeholders and grants management. IP with a-connect. Manage projects and cross-cutting efforts to support the Global Health (GH) product development strategy with a focus on the clinical research component of development, driving effective management of the Global Health Clinical Consortium, facilitating communications with internal and external stakeholders and grants management.
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a-connect
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Switzerland
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Business Consulting and Services
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1 - 100 Employee
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Independent Consultant
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Sep 2013 - Mar 2014
• Led clinical and product development partners (NGOs) to define strategies to optimize funds utilization. Led prioritization and process mapping workshops. Created and facilitated 7 working groups to pilot initiatives • Analysed collective findings to identify R&D funding opportunities, validated assumptions on real impact • Formulated data-driven funding recommendations (e.g. pursuit of Requests for proposals) and delivered funding-enabling business cases presented to the grantees consortium (2014)
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Goodpharmaceutical pte
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Singapore
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New product development, dermatology (independent consultant)
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Aug 2013 - Sep 2013
Good Pharmaceutical Pte Ltd (Health products and Pharmaceuticals distributor start-up) Singapore Market Research & New Product Development • Evaluated commercialization opportunities in US & SE Asia by conducting primary and secondary research • Co-development of new medicated products with public technology transfer and formulation partners. • Created target product profile and scenarios for distribution based on competitive & regulatory intelligence Good Pharmaceutical Pte Ltd (Health products and Pharmaceuticals distributor start-up) Singapore Market Research & New Product Development • Evaluated commercialization opportunities in US & SE Asia by conducting primary and secondary research • Co-development of new medicated products with public technology transfer and formulation partners. • Created target product profile and scenarios for distribution based on competitive & regulatory intelligence
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Roche
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Switzerland
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Biotechnology Research
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700 & Above Employee
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Global clinical project manager , early phase (independant consultant)
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Mar 2012 - Aug 2012
Project management: Planed and conducted over 10 global R&D projects in complex therapeutic areas: • Developed $0.9-16m project budgets, kept their variances under 5%. Forecasted and monitored 3 year patient treatment costs and investigators grants • Led 2 kick-off meetings targeting 100-160 scientists from 25 countries, to support project start and buy-in Process improvement: Implemented best practices & tools across projects and regions: • Shortened projects timelines by 10% compared to benchmark. Streamlined regulatory approval processes across countries. Built a finance process map and landscape analysis for Roche's cost awareness initiative • Implemented clinical trial management systems, clinical data standardization tools and electronic records Vendors and contracts management: • Selected vendors and affiliates based on evaluated risk, cost and capabilities. Led bid defence meetings, drafted requests for proposals and agreements, monitored and evaluated performance, mitigated and managed change orders. Engaged multiple networks in public health • Advised regional affiliates on contracting objectives with public & private Healthcare delivery partners
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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European and international study manager, oncology - hematology
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Apr 2010 - Oct 2011
Phase II, Phase III registration trial , Hematology (Arzerra) Maintenance of European Medicines Agency's approval • I managed international clinical trial operations supporting a further conditional approval of Arzerra in Europe for the treatment of refractory chronic lymphocytic leukemia. Trials details available through ClinicalTrials.gov identifier: NCT01014208 • I also managed the set-up of another Ofatumumab trial supporting an extension of indication for Arzerra Ofatumumab is a monoclonal antibody (for the CD20 protein) FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab.
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Eisai US
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Clinical Research Associate
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Nov 2007 - Mar 2010
• Operational point of contact on a major outsourced oncology global phase III trial • Instrumental in progressing the pivotal study of Eribulin for metastatic breast cancer indication through its set-up, maintenance and close-out phases up to registration. • My efforts and successful collaboration with a major CRO contributed to subsequent marketing authorizations granted by the FDA, EMA, Japan, Switzerland & Singapore health authorities, and national health system reimbursement in various countries. The specialty is now commercially available as HALAVEN®
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Theradex Oncology
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United States
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Biotechnology Research
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100 - 200 Employee
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Senior Clinical Research Associate
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Jan 2006 - Nov 2007
• International monitoring, German and French speaking countries • Phases I-III, Oncology (Breast ph.II, Melanoma ph.III, Neuroblastoma) • Training and oversight of data quality at the investigating sites and within the team • International monitoring, German and French speaking countries • Phases I-III, Oncology (Breast ph.II, Melanoma ph.III, Neuroblastoma) • Training and oversight of data quality at the investigating sites and within the team
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Veterinary surgeries
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France - various
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Locum and assistant veterinarian
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Mar 2004 - Dec 2005
• Worked as a locum veterinary surgeon or/and assistant in rural areas • Small animals and large animals prophylaxis campaigns • Worked as a locum veterinary surgeon or/and assistant in rural areas • Small animals and large animals prophylaxis campaigns
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Sogeval Laboratories
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United States
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Veterinary Services
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1 - 100 Employee
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Interim international accounts manager, small animals division
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Nov 2004 - Apr 2005
• Coordinated EU exports of palatable antibiotics • Managed a network of EU distributors, and increased external communication and awareness of the company and brands • Contributed to the launch preparation of a dermatological range (Douxo products) Covering the above for a maternity leave • Coordinated EU exports of palatable antibiotics • Managed a network of EU distributors, and increased external communication and awareness of the company and brands • Contributed to the launch preparation of a dermatological range (Douxo products) Covering the above for a maternity leave
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Education
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INSEAD
Master of Business Administration (MBA), (Finance and entrepreneurship electives) -
Université Pierre Mendès-France (Grenoble II)
BSc, Economics -
Ecole nationale vétérinaire de Nantes
Dr Vet Med, Veterinary medicine / surgery -
Lycée Marcelin Berthelot
Classe Preparatoire Grandes Ecoles | French Grandes Ecoles Undergrad prep cycle, Maths, Physics, Chemistry, Biology