Study Director/Senior Scientist

MedPharmDurham, NC
Onsite

About The Position

The Study Director is responsible for the scientific conduct of assigned studies and functions as the liaison between laboratory staff and the Project Manager. This role is ideal for candidates passionate about science who want to remain closely involved without performing hands-on laboratory work. Responsibilities include supervising and coordinating client projects, identifying areas for improvement, developing new processes, and leading the execution of assigned studies. The studies are pre-clinical in vitro studies, including In Vitro Release Testing (IVRT), In Vitro Permeation Testing (IVPT), and Research Biology. The majority of studies are conducted under R&D, with a small percentage under a regulated setting.

Requirements

  • Bachelor’s degree in a relevant scientific field (e.g., Chemistry, Biology).
  • 3-5 years of relevant experience.
  • Proficiency in technical writing.
  • Ability to analyze data sets and interpret results.
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.).

Nice To Haves

  • Familiarity with JMP.

Responsibilities

  • Provide strategic and technical oversight on studies.
  • Collaborate on continuous process improvement opportunities.
  • Draft study plans and contribute to the preparation of reports for sponsors.
  • Function as the Subject Matter Expert (SME) on studies, particularly on sponsor calls.
  • Ensure that for regulated studies: the study protocol is approved and followed, all experimental data is accurately recorded and verified, unforeseen circumstances affecting study quality are noted and documented, test systems are as specified, regulatory guidelines are followed, and all data is transferred to archives.
  • Adhere to MedPharm’s Procedures.
  • Contribute to the preparation and review of SOPs and Forms.
  • Promptly record all data according to Good Documentation Practices.
  • Review literature in preparation for studies and update knowledge.
  • Train, assist, or assign tasks to others.
  • Perform any other assigned duties.
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