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Study Director
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.
- Prepare and amend study plans, testing protocols, reports, study updates, and study-related documents.
- Function as the Subject Matter Expert (SME) on studies, particularly on sponsor calls.
- Review literature in preparation for studies and regularly update knowledge in relevant areas.
- For any regulated studies, assure that:
- All work is performed in accordance with GLP (Good Laboratory Practice).
- The study plan, including any changes, 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 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.
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Assigned Studies
The studies that a study director would be leading are mainly formulation development and process development at the MedPharm Research & CTM Supply site. Most of the assigned studies would include but are not limited to the following:
- Formulation development and proof of concept studies
- Process development
- Toxicology batch manufacture and release
- Reverse engineering
The majority of the assigned studies will be conducted under R&D with a small percentage conducted under a regulated setting (e.g. GLP release).
Education and Experience
- Bachelor’s degree in relevant scientific field (e.g. Chemistry, Biology, etc.)
- 3-5 years of relevant experience
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Knowledge, Skills, and Abilities
- Proficiency in technical writing
- Must be able to analyse data sets and interpret results
- Familiarity with JMP is a plus, but not required
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.
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 may occasionally be required to walk; sit; climb or balance and stoop. Specific vision abilities required by this job include close vision, distance vision, colour 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.
MedPharm will send all communication using our company email address, which includes our official signature, and requires you to complete an online application as part of the process.
MedPharm is unable to offer any form of visa sponsorship at this time.
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