Senior Scientist, Translational Medicine
Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Scientist, Translational Medicine.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Leads efforts in clinical assay development: sorts technologies and develops fit-for-purpose assays, oversees the development, qualification and validation profiling assays, and aids in tech transfer to CROs.
- Supervises vendor management, transfers in-house methods, evaluates assay validation plans and reports, leads technical discussions and drives actionable troubleshooting efforts, oversees vendor milestones aligned with study timelines.
- Plans large-scale testing of clinical specimens with cross functional support.
- Analyzes, interprets, and presents data summaries to characterize PK/PD, and provides technical and strategic recommendations in context with clinical study goals and other translational/clinical data.
- Represents Translational Medicine function in study management and clinical development cross-functional teams.
- Leads value-driven and timely scientific decisions.
- Supports budget planning and management.
- Mentors and supervises junior staff, contributes to the development and maintenance of a positive team-focused company culture.
- A PhD in Immunology, Renal Biology, or related field is required.
- Must have 6+ years of relevant post-graduate experience including experience in industry implementing translational research efforts in the clinical setting.
- Requires Expertise in the design and execution of biomarker assays, with the ability to utilize a wide range of techniques to support mechanistic studies to characterize immune phenotype and function.
- Must have knowledge in bioanalytical assay (BA) development/validation and an understanding of current regulatory standards for BA assays.
- Familiarity with clinical development documents including clinical study protocols, sample collection manuals, informed consents, and regulatory filings is required.
- Must have excellent interpersonal skills, problem-solving skills, and the ability to apply scientific methods to resolve potential issues.
- Ability to work in a fast-paced environment across multiple projects, and adapt to changing priorities is required.
- Must be detail oriented and be able to prioritize workload with limited supervision.
- Excellent verbal and written communication skills are required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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