Senior Scientist, Clinical Operations – ID/Vaccines

Role Overview

• This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof.
• Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s).
• Serving as the lead clinical scientist on the clinical trial team.
• Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.
• Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments);
• Partners with the Study Manager on study deliverables.
• Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
• Providing tactical/scientific mentorship to other clinical scientists.

Requirements

• Bachelor's degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR master's degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD degree
• Degree in life sciences, preferred.
• Accountability
• Adaptability
• Clinical Data
• Clinical Study Design
• Clinical Trial Compliance
• Clinical Trial Management
• Data Analysis
• Ethical Standards
• ICH GCP Guidelines
• Medical Writing
• Motivation Management
• Regulatory Documents

Tech Stack

• Google Cloud Platform

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days