Careers

As clinical lead, the candidate will be responsible for scientific and medical/clinical oversight of clinical trials. This role will provide medical/clinical input into the design and conduct of clinical trials as well as assessment and interpretation of clinical data.

This role reports to the VP, clinical development and regulatory affairs.

Responsibilities

• Support the development of Clinical Development Plans, including target diseases/patient populations
• Provide medical/clinical leadership in the design and conduct of clinical trials, including drafting of protocols and respective amendments, informed consent forms, and other supporting documents
• Provide medical support for clinical trials and act as medical monitor
• Lead medical/clinical reviews, assessment and interpretation of efficacy and safety data to ensure that the data are presented with the appropriate medical interpretation
• Provide medical/clinical input into Investigator Brochure, safety reports, including SAE narratives and analysis of similar events, Clinical Study Reports and scientific publications
• Contribute to CRO, site and investigator training
• Contribute to developing and maintain relationships with the medical community, investigators and Key Opinion Leaders
• Responsible for medical/clinical monitor input into the development and implementation of standard operating procedures for all aspects of Adverse Event report handling, aggregate reporting and assuring compliance with global and local regulatory requirements
• Responsible for implementing alignment across policies/procedures and ensuring that data generated are compliant with FDA and ICH guidelines and GCP

The candidate

• MD (experience in endocrinology and metabolism a plus) or PhD in relevant discipline
• 8+ years’ experience in drug development or clinical research (biotech or pharmaceutical industry preferred)
• EU experience, US experience a plus
• Fluent in oral and written English
• Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs
• Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders
• Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing

Posted: October 8th, 2020

Rattaché(e) au Directeur Opérations Cliniques, vous êtes en charge de la gestion et de la coordination des activités opérationnelles des études cliniques. Dans ce cadre :

• Vous gérez et coordonnez les activités opérationnelles d’études cliniques
• Vous êtes garant du respect des objectifs, du planning, du budget alloué, des objectifs qualité fixés pour l’étude, conformément au protocole, procédures, réglementations locales, aux contrats avec les CROs/prestataires et au plan de développement clinique
• Vous contribuez à l’élaboration et la revue des protocoles d’études cliniques et en assurez la faisabilité opérationnelle
• Vous élaborez ou revoyez tous les documents nécessaires à la mise en place et à la bonne conduite d’études cliniques
• Vous pilotez le processus de sélection des CRO et autres prestataires cliniques depuis l’établissement du cahier des charges jusqu’au choix final, puis vous encadrez et supervisez les prestataires retenus et vous assurez le pilotage au quotidien de leurs activités.
• Vous encadrez et gérez la sélection des sites d’investigations, incluant les études de faisabilité pour assurer la sélection des pays/sites appropriés
• Vous participez aux visites de mise en place des sites d’investigations
• Vous assurez les activités de co-monitoring
• Vous assurez la bonne transmission des informations et la bonne coordination des activités entre les équipes pluridisciplinaires tant internes qu’externes.
• Vous identifiez les risques de manière proactive et mettez en place les actions correctrices et préventives selon le plan de contingence de l’étude, en lien avec les experts métiers
• Vous coordonnez les activités du rapport d’étude clinique ainsi que les activités d’archivage du dossier d’études cliniques

De formation initiale BAC + 4 minimum, vous justifiez d’une expérience opérationnelle confirmée d’au minimum 5 ans dans la conduite d’études cliniques mono ou multi centriques, et internationales sur un poste équivalent en milieu industriel (laboratoires pharmaceutiques / biotech / CROs cliniques), depuis les phases précoces jusqu’aux phases avancées du développement du médicament.

Vous avez d’excellentes compétences organisationnelles et de planification, et savez identifier les problèmes et proposer des solutions.

Diplomate, vous avez géré avec succès différents types de prestataires externes et avez su maintenir leur engagement et leur motivation au profit du projet

Rigoureux(se) et très autonome, vous avez d’excellentes qualité de communication tant écrites qu’orales et votre anglais est courant.

Vous maitrisez la réglementation clinique en vigueur et son cadre réglementaire et éthique ainsi que les directives ICH, et spécialement des Bonnes Pratiques Cliniques.

Posted: May 19th, 2021

This candidate will be responsible for the vendor management, the protocol development, the study implementation and the report writing. The right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for the company along with a deep scientific knowledge.

This role reports to the director preclinical development and is based in Ecully, France.

Responsibilities:

• Prepare scope of work and solicitate proposals
• Assist in CRO selection
• Manage study contracts, budgets, purchase orders, invoices
• Ensure prioritization at CROs align with internal objectives and priorities
• Monitor established KPIs to ensure best practices for vendors
• Develop detailed study protocols
• Assess technical ability of CRO to meet study objectives and coordinate development of additional technical tools when deemed necessary
• Resolve scientific or logistical concerns with CRO regarding components of study protocols
• Ensure the protocol meets GLP expectations and protocol-related documentation is available to the CRO prior to study start
• Manage study achievements and metrics to ensure delivery study milestones
• Visit CRO during critical phases of the study to ensure technical capabilities are adequate and procedures match the protocol
• Interact with CRO as the first line of contact for any study-related issues. Make the initial determination of the impact of the issue on the integrity of the study
• Review and QC nonclinical toxicology, pathology, and DMPK data and reports
• Coordinate and monitor the internal review and interpretation of study data
• Prepare summaries and updates for internal communication to project team and management
• Compile all report comments and assure they are conveyed to the Study Director before finalization
• Integrate and assemble toxicology information for regulatory documents (CTA, IND/CTD, IB)

The candidate:

• PharmD, VetD, Master degree in Biology, Animal Sciences, Toxicology or a related field
• > 3 years of experience as a toxicology study director/monitor in pharma, biotech or CRO setting
• Understands the purpose, components and outcomes of drug development and safety assessment
• Expertise in management of nonclinical study conduct, including the fundamentals of Good Laboratory Practices (GLP) and data interpretation of nonclinical studies
• Understand the technical capabilities of individual CROs
• Fluent in oral and written English
• Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders

Posted: July 28th, 2021