Recruitment

We currently have 2 positions available:

Senior Director Regulatory Affairs & Quality Manager

Job description

The Senior Regulatory Director provides strategic and operational regulatory expertise for Vivet's programs, including, with respect to product development stage, valuation, strategic development plan with experts in the company, registration, and approval/post approval.

The Senior Regulatory Director defines and executes regulatory plans in line with the defined regulatory strategy. This is a strong leadership role responsible for ensuring compliance with regulations, while optimising interactions with regulatory authorities. The Senior Regulatory Director must understand and challenge the dynamic regulatory landscape, while creating opportunities in the highly-regulated and complex environment, specifically for ATMPs & orphan diseases.

As the Quality Manager, and with the support of a consulting group, ensure the implementation and follow up of a quality system regarding clinical, CMC (outsourced), regulatory and non-clinical activities, in line with a phase 1/2 clinical-stage company.

Please send your resume at recrutement@vivet-therapeutics.com

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Functions

Functional management

 

Scientist

Job description 

Postdoctoral fellow with broad experience in Molecular Biology. Experience in the fields of Gene Therapy, development of viral vectors, and/or research on liver diseases will be highly considered. Leadership, initiative and the capacity to work as part of a team are necessary qualities of the candidate. Experience in environments requiring a high level of organization and meticulous record keeping will be highly desirable, as well as experience in the biotech industry. Previous postdoctoral research experience required (2-5 years, preferably international); a strong publication record will also be of value. The project is based on the development of adeno-associated viral vectors for gene therapy of genetic liver diseases.

Specific Tasks:

   - Work on a project based on the development of adeno-associated viral vectors for gene therapy of genetic liver diseases and improvement of vector stability.

   - Proactively design and organize all preclinical experiments to be performed in the project, including proof-of-concept, mechanism of action and lead optimization.

   - Supervise all personnel involved in the project, and of all experiments and data analysis.

   - Writing of experimental protocols and final reports upon specific procedures.

   - Will also be involved in technical aspects of the project: vector production, purification and characterization. In addition will operationally contribute to cellular, biological and biochemical assay development.

   - Take part in animal handling, treatment, and sample collection, processing, analysis and quantification.

   - Work closely with scientists at the Center for Applied Medical Research (CIMA), at the University of Navarra, in the design of all experimental settings before protocol approval.

   - Perform such other research activities as are requested by the Project Manager.

   - Provide regular reporting and accounting on activities to the Project Manager.

The candidate should be able to work well together with academic- and industry-based collaborators, as the project incorporates team members working within academic laboratories and other industry partners. In-depth knowledge of the biotech industry will be a plus. The position will report to the Project Manager.

Travel may be required (<10%). 

High level of spoken and written English required; Spanish a plus.

Please send your resume at recrutement@vivet-therapeutics.com 

Location 

Pamplona, Spain