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