Monopar Therapeutics is a growing, clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs. For Wilson Disease, Monopar is developing ALXN1840, a late-stage rare disease candidate which completed a Phase 3 trial, and MNPR-101, a novel radiopharmaceutical in Phase 1 trials targeting uPAR, which is found in multiple aggressive cancers.

Responsibilities

• Contribute to our cutting-edge radiopharmaceutical development program 
• Conceptualize, plan, design, place, execute, and summarize clinical trials  
• Drive daily vendor and site management, including collaboration with Study Medical Monitor and KOLs to determine the medical and scientific needs 
• Effectively communicate project-related information including the planning and execution of meetings and presentations as well as creation and maintenance of metrics, e.g., dashboards, timelines, resources, and budgets 
• Contribute to regulatory filings (e.g., IND / IMPD / CTN, NDA)  
• Identify issues and propose solutions. Proactively assess potential risks to the clinical study and propose mitigation plans 
• Work in an office (Wilmette, IL north of Chicago) with a dynamic, talented team 

Qualifications

MINIMUM EXPERIENCE

• Biotech or Pharma company clinical operations experience in progressively responsible positions, including Senior/Clinical Project or Trial Manager 
• 7+ years’ experience managing clinical trials including study design and initiation, oversight, study closeout, project management, and regulatory filings 
• Demonstrated ability to plan and execute Pharma-Sponsored clinical trials, managing vendors and resources in effective & creative manners to achieve business needs including on-time, on-budget, and on-spec study results for successful use in regulatory marketing applications 
• Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA), and European regulations 
• Excellent communication (oral and/or written), leadership, and risk mitigation skills plus a positive attitude 
• Require minimal guidance; is able to function in an independent manner 
• Proven ability to effectively manage internal and external personnel in clinical trial conduct 

PREFERRED EXPERIENCE

• 9 years’ clinical trials experience in pharmaceutical or biotechnology firms
• Experience in oncology trials
• Experience managing clinical trials in Europe and/or Australia
• Experience in a small or growth-stage biopharma company