Clinical Scientist Associate Director, Inflammation

Role Summary

Clinical Scientist Associate Director, Inflammation. This role supports late-phase clinical development by contributing to protocol development, study start-up, data review and monitoring and analysis activities. Working collaboratively with the study team and clinical leadership, this role focuses on study-level implementation and cross-functional coordination to help ensure high-quality, decision-ready clinical data.

Responsibilities

• Support set up and execution of late phase clinical trials with a focus on data quality.
• Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity.
• Provide input into and implementation of data management plan, CRF design, and data review oversight.
• Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission.
• Assists Development Lead and Clinical Scientist Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects.
• Anticipate and actively manage problems across a broad spectrum of cross-functional teams.
• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents.
• Support appropriate training, recruitment, and development requirements for matrix team resources.

Qualifications

• Required: Doctorate degree and 3 years of clinical development experience
• Required: Master’s degree and 5 years of clinical development experience
• Required: Bachelor’s degree and 7 years of clinical development experience
• Required: Associate’s degree and 12 years of clinical development experience
• Required: High school diploma / GED and 14 years of clinical development experience
• Preferred: 3 years of pharmaceutical clinical drug development experience
• Preferred: Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
• Preferred: Industry or academic experience supporting late-phase drug development within a relevant therapeutic area or disease indication
• Preferred: Strong communication and presentation skills, with the ability to clearly convey scientific concepts and clinical data to cross-functional teams and leadership audiences, both written and oral
• Preferred: Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
• Preferred: Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
• Preferred: Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance
• Preferred: Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences
• Preferred: Experience in clinical data analysis such as Spotfire or other data analysis tools