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Study Director/Senior Scientist

MedPharm

Durham, NC

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Biology, Chemistry, Corrective Action, Data Analysis, Data Sets, Depth Perception, Documentation, FDA (Food and Drug Administration), In Vitro Testing, Laboratory, Lift/Move 25 Pounds, Lift/Move 50 Pounds, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Physical Demands, Pre-Clinical Trials, Process Development, Process Improvement, Project/Program Management, Record Keeping, Regulations, Reporting Skills, Research & Development (R&D), Research Protocols, Standard Operating Procedures (SOP), Technical Strategy, Technical Writing, Testing, Willing to Travel
LOCATION
Durham, NC
POSTED
30+ days ago
NOTE: The title, Study Director, refers to the individual responsible for the scientific conduct of assigned studies and should not be interpreted as department head, manager, director, etc.  While this is not a laboratory role, it is ideal for candidates who are passionate about science and want to remain closely involved without performing hands-on laboratory work.


Position Summary
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.


Essential Functions
  • 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.
Assigned Studies
  • 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).

Education and Experience
  • Bachelor’s degree in relevant scientific field (e.g. Chemistry, Biology, etc.)
  • 3-5 years of relevant experience
Knowledge, Skills, and Abilities
  • Proficiency in technical writing
  • Must be able to analyze data sets and interpret results
  • Familiarity with JMP is a plus, but not required
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.
Travel Requirements
  • Up to 5%
Physical Demands and Work Environment
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.  Duties, responsibilities and activities may change at any time with or without notice. 
 

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