Clinical Research Data Scientist

Monopar is a growing biotech company seeking a bright, motivated, and collaborative Clinical Research Data Scientist to support the company’s late-stage rare disease and Phase 1 radiopharmaceutical pipeline. You will join a growing, talented team and will be a member of the core cross-functional team that is leading an FDA New Drug Application for Monopar’s Wilson disease candidate with significant opportunities for impact and growth.

What you'll do...

The Clinical Research Data Scientist applies advanced data analysis and statistical methodologies to clinical trial data, synthesizes findings into clear and concise summaries for internal and external communication, and supports future commercial operations. This role will work cross-functionally with scientists, clinicians, statisticians, and management to generate actionable insights that support the company’s regulatory filings and scientific publications. The main activities include analysis and reporting of clinical trial data, creation of documentation for regulatory filings, and supporting the development of program regulatory and market initiatives.

• Contribute to advancement and filing of a New Drug Application (NDA) for Monopar’s late-stage rare disease program
• Review and analyze data objectively to lead Monopar’s rare disease team toward recommendations that highlight opportunities, address potential risks, and proactively provide appropriate mitigations
• Support statistical analysis and exploratory data analysis (EDA) to uncover insights from complex biomedical and real-world datasets
• Develop and apply quantitative models to analyze clinical trial data, patient outcomes, and real-world evidence (RWE)
• Analyze and interpret clinical outcomes, safety, and other program data into clear and concise summaries, diagrams and presentations
• Create clear and effective visualizations to communicate insights to technical and non-technical audiences
• Ensure data quality, integrity, and compliance with regulatory standards.
• Work in a team-oriented setting across scientific disciplines to support overall program goals and regulatory submissions
• Effectively communicate project-related information including the planning, creation and maintenance of key metrics (e.g., timelines, deliverables, budgets)
• Work in an office (Wilmette, IL north of Chicago) with a dynamic, talented team

What skills & experience you’ll bring to us…

Required Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field)
• A minimum of 5 years of experience in data management and/or research with a focus within the biotechnology industry
• Knowledge of FDA and ICH guidance documents and regulations
• Proactive attitude with a demonstrated ability to adapt to new challenges and evolving project needs
• Strong organizational abilities with ability to manage multiple tasks simultaneously and prioritize effectively
• Excellent communication (oral and/or written) and analytical skills to facilitate clear and effective communication with internal teams and external partners
• Multitasker, self-starter, proactive, problem solver; ability to work effectively both independently and collaboratively in a team environment
• Possess a sense of curiosity and interest in science

Preferred Qualifications

• Advanced degree in a scientific discipline (e.g., Master’s or PhD)
• Experience supporting a successful New Drug Application
• Experience in development of investigational products with Fast Track designation, or other expedited regulatory development pathways; experience with Orphan Drug development (desirable)
• Experience in analyzing large datasets to support drug development decisions
• Knowledge of pharmaceutical regulatory guidelines and GxP compliance

Monopar Therapeutics (NASDAQ:MNPR) is a clinical-stage biotechnology company developing a new treatment for Wilson Disease, a rare genetic disorder, and novel radiopharmaceuticals for oncology. Its pipeline includes late-stage ALXN1840, a treatment for Wilson Disease, and radiopharmaceuticals to image and treat advanced solid tumors, including Phase 1 MNPR-101-Zr for imaging as well as Phase 1 MNPR-101-Lu and late-preclinical MNPR-101-Ac for therapy.