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:
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.
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.
Scientific & Safety Data Oversight : Analyze and interpret clinical trial data, perform safety reviews, ensure data quality, and support safety reporting (e.g., DSURs, SUSARs).
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).
Governance & Risk Mitigation : Represent Clinical Science in study teams, manage study-specific plans, provide timely deliverables, and proactively identify risks and mitigations for successful trial execution.
Experience Needed:
MD/MD PhD
2 Years experience in the pharmaceutical industry
Rare Disease experience preferred
If this role could be something of interest to you, please feel free to apply through the job advertisement or reach out to me at jamie.stephens@arto-talent.com.
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