Job Description
ARTO is currently partnered with a globally renowned mid sized Pharmaceutical company who are committed to the development of drugs within the Rare Disease space.
With a growing clinical development team, they are currently searching for an Associate Medical Director who will be able to assist with the development of drugs up to the crucial IND/BLA submission phase.
Key Responsibilities:
1. Document Development & Regulatory Support: Create key trial documents (e.g., IND Annual Reports, Investigator Brochures, Briefing Books) and support regulatory submissions and compliance with guidelines.
2. Clinical Development & Study Design: Contribute to Clinical Development Plans (CDPs), develop protocols and methodologies, and collaborate on Statistical Analysis Plans (SAPs) while ensuring alignment with project timelines.
3. Scientific & Safety Data Oversight: Analyze and interpret clinical trial data, perform safety reviews, ensure data quality, and support safety reporting (e.g., DSURs, SUSARs).
4. Communication & Collaboration: Act as the scientific lead liaising with key stakeholders (e.g., PIs, KOLs, DMCs, Pharmacovigilance, Biometrics), ensuring effective study execution and compliance with Good Clinical Practice (GCP).
5. Governance & Risk Mitigation