Primary Objective:
The Study Director is the primary point of contact for client sponsors regarding scientific design, PDX tumor model selection, and project execution. Provides expertise on the Tumorgraft/PDX mouse platform for preclinical drug testing, collaborating with Business Development, Lab, and Facilities Operations to develop protocols and deliver study updates, analyses, and reports.
Responsibilities:
- Serve as scientific/technical lead in client meetings for pre-clinical PDX opportunities.
- Manage technical studies with expanded endpoints (e.g., immuno-oncology, hematological studies; ex-vivo analyses such as 2D/3D cell assays, Luminex, ELISA, flow cytometry).
- Define client scientific requirements; develop study design/protocols per IACUC guidelines.
- Recommend tumor model selection (and replacements as needed).
- Make real-time study recommendations based on incoming data.
- Review formulation documents and ensure agents/standards of care are in stock before initiation.
- Organize kickoff and protocol review meetings with clients and internal staff.
- Monitor study data; identify and communicate adverse events to sponsors timely.
- Issue lab directives based on data and protocol endpoints.
- Provide weekly updates, data analysis, and final reports.
- Perform data and statistical analyses at study completion.
- Prepare final reports with proposed next steps.
- Coordinate projects with Business Development, Operations, and other personnel.
- Resolve issues in ongoing studies; contribute to process improvements.
- Represent the company at client meetings and scientific conferences.
- Conduct periodic program reviews; align suggestions with pipeline.
- Identify new opportunities with existing clients.
Qualifications / Skills:
- Depth of scientific knowledge in preclinical research platforms.
- Molecular biology expertise (cell-based assays, ELISA, PCR, IHC); flow cytometry data analysis experience a plus.
- Knowledge of project management and oncology research; in vivo oncology models (Xenograft/PDX) required; preclinical drug development a plus.
- Strong customer service, interpersonal skills, and tact; persistent.
- Ability to balance multiple priorities with high attention to detail; frequent adaptation and accountability.
- Effective oral and written communication.
- Proficiency with Microsoft Word and Excel and Statistical Software such as GraphPad Prism.
Education / Experience:
- Ph.D. in chemical/biological science preferred.
- 3β5 years of experience in pre-clinical research or similar role.