LinKinVax is developing a unique and innovative vaccine platform to accelerate the delivery of safe, effective and scalable vaccines, based on the work of the Vaccine Research Institute (VRI), a French laboratory of excellence created in 2011. This DC Targeting vaccine platform is universal and adaptable to changes and mutations in target pathogens.
Five vaccines will be offered to the market over the next five years, including a vaccine already in clinical trials for HIV in 2021, and two vaccines that will be in clinical phase in 2023 (SARS-CoV-2, HPV-related cancer). In addition, LinKinVax supports upstream research to adapt its platform to new pathogens.
LinKinVax is the result of the association of leading French scientists and entrepreneurs and benefits from a portfolio of 10 patent families extended internationally.
For more information, please visit https//:www.linkinvax.com
Our company is now recruiting an experienced Clinical Operations Project Manager who will support the implementation of the clinical development plan and will report to the Director of Clinical Operations and be part of the development team.
Translated with www.DeepL.com/Translator (free version)
The LinKinVax Clinical Operations Project Manager will manage a portfolio of clinical trials in collaboration with sponsors and various academic, hospital or private partners, as well as with internal teams on all trials, from feasibility to closure, whether they are clinical operations with academic or industrial promotion. He/she will develop, implement and coordinate trials in a transversal manner with multidisciplinary teams (CRA, TEC, DM, stat, medical writer, regulatory affairs officer, coder, etc.) as well as with healthcare professionals, ensuring compliance with regulations, budgets and deadlines.
He/she will manage all the missions inherent to this function, directly or with internal or outsourced resources, from the implementation/design to the closing of the projects.
Conduct / Validation of the feasibility of clinical study protocols:
Scientific background, with a specialization in Clinical Research.
4/5 years of higher education in life sciences or clinical development: Master’s degree in biology and health or drug sciences with a specialization in clinical trials and drug development / research and engineering in biosciences / research and development … , Pharmacist with a research option or industrial sector ….
Proven professional experience in clinical research, as defined below, acquired in a CRO, pharmaceutical laboratory or biotechnology company.
Clinical Research Experience:
Cross-functional project management (clinical development, regulatory affairs, public affairs, CMC, quality, etc.) in multidisciplinary teams
Clear and structured oral and written communication
Sense of priorities and organization within and between projects
Ability to adapt and manage change flexibly
Experience working in matrix and international organizations
Fluent in French and English, both written and spoken, covering the field of clinical operations
Scientific rigor, excellent organizational and communication skills, autonomy, anticipation, with a recognized ability to analyze and summarize
Knowledge of and compliance with international regulations (GCP, ICH…).
Mastery of office automation tools (Outlook, Powerpoint, Excel, Word, and even Access)