Directeur(rice) opérations cliniques / Head of clinical operations
LKV2021-002-DC
Paris

Full Time

POSITION FILLED

LinKinVax is developing a unique and innovative vaccine platform that accelerates the availability of safe, effective and scalable vaccines, based on the work of the VRI (Vaccine Research Institute), a French laboratory of excellence created in 2011. This platform DC Targeting vaccine is universal, and adaptable to changes and mutations of target pathogens.

Five vaccines will be offered to the market within five years, including one vaccine already in clinical trial on HIV in 2021, and two vaccines that will be in clinical phase in 2022 (SARS-CoV-2, HPV-related cancer). On the other hand, LinKinVax supports upstream research to be able to adapt its platform to new pathogens.

The result of the association of leading French scientists and entrepreneurs, LinKinVax benefits from a portfolio of 13 patent families extended internationally.

For more information, please visit https //: www.linkinvax.com

Our company is now recruiting a team of experienced managers who will support its clinical development.

For the implementation of the clinical development plan, the director in charge of the quality control of the products developed by the company, in relation to the scientific and medical development of the company and in direct contact with our medical and scientific director, our R&D Director and our Director of Operations:

  • to structure the LinKinVax quality assurance department,
  • to be in charge of the management and quality control of products and
  • to ensure regulatory monitoring in accordance with French, European and international standards
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Mission

A / Structuring of LinKinVax’s clinical operations department

  • Recruitment of the team and the skills necessary for the implementation of clinical operations
  • Management and animation in line with the objectives of the company
  • Budget and human resources management of your organization

B / Organization of the conduct of clinical trials

  • Participation in the definition of the clinical strategy of the products in order to achieve success while respecting deadlines and costs
    • Manage the drafting of the protocol and the information and consent note, ensure its translation and its formatting according to the countries and regulatory agencies concerned
    • Ensure the regulatory compliance of protocols with Good Clinical Practices and the legal and regulatory provisions in force in relation to clinicians, scientists and service providers involved in clinical trials
    • Write specifications and participate in the selection of service providers necessary for the conduct of clinical trials, monitor services and validate invoicing
    • Monitor and ensure compliance with contractual deadlines with service providers and deliverables
    • Set up the tools for piloting and monitoring the test according to the objectives and in connection with logistics operations
    • Regulatory and administrative management as or in connection with the promoter: insurance; authorization request from the regulatory authorities (ANSM, CPP, CTTIRS, CNIL, etc.) in collaboration with the logistical organization of the conduct of the trial (academic or CRO) and the coordinating and / or industrial investigator
    • Evaluation of the overall and annual research budget by clinical trial and the hospital additional cost in collaboration with the logistical organization of the conduct of the trial (academic or CRO) and the coordinating investigator and / or industrialists; Budget monitoring.
    • Development of a roadmap with the various stakeholders for each clinical trial
  • Management and monitoring of the proper conduct of the clinical trial in supervision / collaboration with the logistical organization of the conduct of the trial (academic or CRO) and the coordinating and / or industrial investigator
  • Participation in Scientific Councils of studies
  • Administrative and budgetary management
  • Responsible for writing and validating the final report in conjunction with the scientists
  • Realization of the hospital overcost report
  • Organization, follow-up and drafting of reports of clinical trials steering meetings
  • Organization of ancillary studies and management of samples (biology, immunology, virology)
  • Link with statistical centers and methodologies

C / Regulatory monitoring

  • Regulatory watch and pharmacovigilance
  • Compliance of the company’s regulatory files with national and international regulatory changes.
  • Link and representation of the company to health authorities, negotiation with these authorities in conjunction with the regulatory department
  • Audit of CROs and clinical centers
  • Definition, coordination and planning of registration plans (pharmaceutical, pharmacological, toxicological, clinical files, etc.).
Job profile

You are a doctor of medicine or science, you have at least 10 years of professional experience in the field of phase 1 and 2 clinical studies acquired in the academic or industrial field. Experience in clinical vaccine development would be an asset.

You are familiar with European and American regulations and the rules of Good Clinical Practice for phase 1 and 2 clinical trials, first administration in humans, and trials in healthy volunteers.

You understand scientific methods and are able to communicate scientific results to agencies and interact with academia and the private world.

You are autonomous, able both to build a strategy and to put in place the operational means necessary to achieve our objectives

Absolutely essential oral and editorial skills

Fluent English level, oral and written