Preclinical Project Manager

We are seeking a motivated scientist to coordinate NoctuRNA’s preclinical development activities and support the regulatory strategy for our RNA-based drug candidates.

Main tasks:

• Plan, coordinate and monitor preclinical studies (in vitro and in vivo) in collaboration with internal teams and external CROs.
• Contribute to CMC and non-clinical development plans for RNA-based drug candidates.
• Prepare, compile and review scientific and regulatory documentation (study protocols and reports, summaries, risk assessments, etc.).
• Support the preparation of regulatory dossiers for early development (e.g. non-clinical and CMC sections of CTA/IND/IMPD or equivalent).
• Ensure alignment of preclinical activities with relevant regulatory guidelines and industry standards.
• Collaborate with multidisciplinary teams (biology, CMC, clinical, business) and contribute to grant applications and other project proposals

Requirements:

• PhD in biology, biotechnology, molecular biology or a related life-science discipline
• Solid understanding of the different phases of drug development, particularly non-clinical and early clinical stages
• Previous experience in the biotech/pharma sector in roles related to regulatory affairs, CMC and/or preclinical project management
• Experience interacting with CROs and coordinating preclinical studies
• Ability to analyze, interpret and synthesize scientific data into clear documentation.
• Organized, proactive and capable of managing multiple projects and deadlines.
• Team player with strong communication skills and the ability to work effectively in a dynamic startup environment.
• High level of written and spoken English. Spanish and/or Catalan are a plus.

Valuable:

• Experience with RNA biology or nucleic acid–based therapeutics.
• Previous involvement in the preparation of regulatory submissions (e.g. CTA, IND, IMPD or equivalent).
• Experience in CMC development for biologics or advanced therapies.
• Laboratory Animal Handling Certification

Why join NoctuRNA Therapeutics?

• Make a meaningful impact in transforming healthcare through novel RNA-based therapies.
• Work in a highly dynamic, science-driven biotech company
• Opportunities for professional growth and increased responsibility at the company scales.
• Full-time indefinite contract and an annual salary according to their skills and experience.