Workplace:
Molecular Nanoscience and Organic Materials Department, NANOMOL-BIO group (https://icmab.es/mnom/nanomol-bio); Institut de Ciència de Materials de Barcelona (ICMAB-CSIC).
NANOMOL has extensive experience and recognized excellence in the synthesis, processing, and study of molecular and polymeric materials with chemical, electronic, magnetic, and biomedical properties. We continuously generate new knowledge in our basic and applied research projects on the micro and nanostructure of molecular materials. We offer this knowledge to improve the properties of products manufactured in different sectors, such as chemical, pharmaceutical, and electronic, thus contributing to increase their added value. As a department, we actively participate in the implementation of nanotechnology and sustainable and economically efficient technologies for the preparation of advanced functional molecular materials. NANOMOL is a member of the Biomedical Research Network (CIBER) in the area of Bioengineering, Biomaterials, and Nanomedicine (CIBER-BNN); and is awarded with the TECNIO seal, which is given to Catalan research groups with high innovative and technology transfer capabilities. We belong to the Institute of Materials Science of Barcelona (www.icmab.es), a CSIC research institute. Our facilities are located on the campus of the UAB (Universitat Autònoma de Barcelona).
The candidate will work in the Nano4Rare project (Preclinical development of a nanomedicine candidate for Fabry rare disease treatment to enter clinical phase), funded by the Strategic EIC Transition Challenges program from European Innovation Council.
As a Nanomedicine Preclinical Researcher, you will play a pivotal role in advancing our project towards clinical phase.
Main Tasks:
You will manage and execute tasks associated with the preclinical development of a nanomedicine, and the necessary regulatory activities prior FIH clinical trials.
Responsabilities:
- Maintain smooth and timely communication throughout the project with team members and collaborators
- Oversee the timely implementation of development and reporting within each work package of the project Nano4Rare
- Lead documentation preparation and consultations with drug regulatory agencies (EMA, FDA)
- Contribute to the design of the preclinical studies prior to FIH clinical trials in collaboration with CROs
- Collaborate with a specialized CRO to create a protocol for the FIH clinical trial
Requirements:
- Ph.D. in Pharmacy or a related field in Health Sciences.
- Strong background in regulatory affairs, particularly in biologicals and drug delivery systems.
- Experience in preclinical development, including knowledge of GLP regulations.
- Demonstrated experience in interacting with regulatory agencies and preparing regulatory submissions (e.g. Briefing documents, Scientific advice procedures, Clinical Trial Application…)
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with a multidisciplinary partnership
- Previous experience in managing cross-functional teams
Others:
- Organized person, proactive, and with good predisposition to teamwork.
- Strong organizational, communication, and coordination skills.
- Ability to adapt to a flexible and changing R&D environment.
- Ability to work independently.
- Advanced English Level, and computer skills at user level.
Conditions:
- The contract will be full time.
- Gross annual salary according to agreement.
- Start of contract: as soon as possible.
How to apply: Send the following application documents to
- Curriculum (CV)
- Motivation letter
- Statement of the applicant's experience
- List of references with contact details
Deadline for submission of applications: the recruitment process will be closed when a suitable candidate is found.
