Study Director/Senior Scientist

MedPharm•Durham, NC

73d

About The Position

A Study Director has the overall technical responsibility of a study and functions as the liaison between the laboratory staff and the Project Manager. Responsibilities include supervising and coordinating activities of client projects, identifying areas of improvement and developing new processes, leading and managing the execution of assigned studies.

Requirements

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

Nice To Haves

Familiarity with JMP is a plus, but not required

Responsibilities

Provide strategic and technical oversight on studies.
Collaborates on continuous process improvement opportunities.
To 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.
For any regulated studies, assure that:
The study protocol (plan), including any change, is approved and is followed.
All experimental data including observations of unanticipated responses of the test system are accurately recorded and verified.
Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
Test systems are as specified in the study protocol (plan).
Regulatory agency's (e.g. FDA, EMA, etc.) guidelines are followed where appropriate.
All raw data, documentation, protocols, specimens and final reports are transferred to the archives during or at the close of the study.
To adhere to MedPharm’s Procedures.
Contribute to the preparation and review of SOPs and Forms where applicable.
Where applicable, promptly record all data according to Good Documentation Practices.
Review literature in preparation for studies and to regularly update knowledge by reviewing appropriate literature.
Supervisory Responsibilities - This position may be responsible for training, assisting or assigning tasks to others.
Any other duties and/or tasks that may be assigned.
The studies that a study director would be leading are pre-clinical in vitro studies conducted at the MedPharm Research & Innovations site.
Most of the assigned studies would include but are not limited to the following:
In Vitro Release Testing (IVRT)
In Vitro Permeation Testing (IVPT)
Research Biology (e.g. various biological models, IVPT on various tissue constructs, etc.)
The majority of the assigned studies will be conducted under R&D with a small percentage conducted under a regulated setting (e.g. in vitro bioequivalence).