Tech Stack

Description

You will contribute to the scientific, clinical, and operational scope of assigned study protocols, working with cross-functional teams to design, execute, and monitor clinical studies, and oversee data review, interpretation, and communication to stakeholders.

Requirements

• PhD, PharmD or equivalent required
• Minimum 8+ years in pharmaceutical/biotechnology industry as clinical scientist or related role
• Proven leadership in collaborative team setting and driven by innovative approaches
• Detail-oriented with ability to prioritize and function independently
• Proficient with Microsoft Office, Electronic Data Capture, and web-based software

Responsibilities

• Develop and execute clinical development strategies and Clinical Development Plan (CDP) focusing on early-phase development
• Lead cross-functional teams to conduct clinical studies including start-up, execution, close-out, data review/analysis, and study reports
• Oversee development of program-level documents: protocols, investigator's brochure, clinical study reports, abstracts, manuscripts, presentations
• Conduct ongoing data reviews and prepare/present summaries to internal and external stakeholders
• Ensure trial implementation per protocol, analyze issues related to protocol conduct or subject safety, and interact with stakeholders