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

Monopar Therapeutics Inc.

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Monopar Therapeutics Inc. | Senior Clinical Project Manager