Careers
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Are you looking for a positive and stimulating work environment? Joining Amolyt Pharma means choosing a fast growing, international and pioneering company committed to providing innovative treatments to patients suffering from rare endocrine and metabolic diseases. We are always looking for passionate and talented individuals to join our dedicated team to help us achieve our mission.
Please note that all our job vacancies are published on this page. For safety purposes, please do not respond to solicitations for positions not listed on this page.
While there are no current openings, be sure to check back often to see what new jobs are posted.
Explore our open positions below:
Rattaché(e) au Directeur des Opérations Cliniques, vous êtes en charge de l’exécution et management global des essais cliniques nationaux et internationaux.
Poste basé près de Lyon avec possibilité de télétravail
Missions :
- Management des prestataires externes (sélection et pilotage des activités)
- Respect des objectifs définis, gestion et maitrise des timelines, suivi budgétaire
- Respect des objectifs qualité conformément au protocole, procédures, réglementations locales, aux contrats avec les CROs/prestataires et au plan de développement clinique
- Contribution/élaboration des documents essentiels des études cliniques, incluant le protocole d’étude clinique
- Encadrement et gestion de la sélection des sites d’investigations, incluant les études de faisabilité
- Co-monitoring
- Identification proactive des risques et mise en place des actions correctrices/préventives selon le plan de contingence de l’étude
- Coordination des activités du rapport d’étude clinique ainsi que de l’archivage de l’étude
- Au niveau d’un projet clinique, développement du planning et budget du plan clinique
Profil :
- Diplôme d’études supérieures en Sciences de deuxième ou troisième cycle
- > 10 ans d’une expérience opérationnelle confirmée dans la conduite d’essais cliniques nationaux/internationaux
- > 7 anssur un poste équivalent dans des laboratoires pharmaceutiques/biotech/CROs cliniques (Phase I à III)
- Maitrise de la réglementation clinique en vigueur, de son cadre réglementaire et éthique, des directives ICHs (Bonnes Pratiques Cliniques, etc)
- Expérience confirmée dans le management et pilotage de CROs
- Excellentes compétences organisationnelles et de planification
- Rigoureux/très autonome,
- Excellentes qualités de communication
- Anglais courant
Posted: Oct 4th, 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