Regulatory & Clinical Operations Manager (M/F/X), siRNA | Belgium (hybrid)

At Silengenics, we develop precision gene silencing therapies based on siRNA. Our lead drug candidate, in the cardiometabolic space, is moving towards the clinic, and we are looking for the person who will drive that transition.

Your role

• Lead the regulatory pathway of our drug candidate, from regulatory preclinical work through to first in human
• Coordinate all studies and deliverables required for IND (FDA) and CTA (EMA / CTIS) submissions
• Oversee the operational follow up of our Phase I and Phase II clinical trials
• Act as the internal point of contact for our consultants, CROs and regulatory and clinical vendors (planning, logistics, deliverables and budgets)

Your profile

• PharmD, PhD or MSc in pharmaceutical or biomedical sciences, or equivalent
• Proven experience preparing IND or CTA dossiers, including IND enabling studies (GLP toxicology, CMC, pharmacology)
• Hands on experience with at least one Phase I and/or Phase II trial (planning, CRO selection and management, site follow up, timelines)
• Solid knowledge of European and US regulatory frameworks (EMA, FDA, ICH, GCP); familiarity with the Australian framework is a plus
• Fluent in English; French is a strong asset
• Major plus: experience in cardiometabolic diseases (lipids, cholesterol, cardiovascular) and/or oligonucleotide or RNA therapeutics (siRNA, ASO)

What we offer

• Biopark Charleroi (Gosselies, Belgium), with remote work options
• 6 month fixed term contract, convertible into a permanent position
• A key role at the decisive moment of clinical entry, in a small, ambitious team

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