The Translational Sciences Division of Immunologix Laboratories is seeking a self-driven, highly experienced scientific leader to join our team. Translational Sciences provides dedicated scientific partnership and resource to advise, develop, and implement integrated bioanalytical and biomarker strategies and solutions for innovator development programs ranging from discovery to post-market. Working as a highly interdependent team, we leverage bidirectional synergies with our Laboratory Sciences in Tampa, FL to provide a scientific product second to none. In addition to providing our clients with exceptional expertise, we are equally committed to growing and developing our scientific teams, creating a culture of constant learning and collaboration. This position, reporting directly to the Head of Translational Sciences, will serve as Translational expert on client project teams and be responsible for providing bioanalytical and biomarker strategies for multiple novel therapeutic programs, including scientific oversight of assay development & validation, study sample testing and data interpretation. Authoring of relevant clinical and regulatory documents, including written and in-person interactions with health authorities is also required.
- Develop and implement bioanalytical strategies, including immunogenicity risk assessments, in support of biologics drug development programs that include novel modalities for which regulatory paths have not yet been established
- Provide expert oversight of development and validation of drug concentration (PK) and immunogenicity (ADA and Nab) assays
- Expert interpretation of immunogenicity data, with specific focus on clinical impact and ability to clearly communicate findings to multiple audiences, including health authorities
- Develop and implement biomarker strategies for all therapeutic modalities, with a focus on decision enabling strategies that efficiently progress client projects to key milestones
- Provide expert oversight of development and validation of all associated biomarker assays ensuring methods meet their context of use; oversight of study sample analysis with data interpretation that integrates an understanding of biology, pre-analytical & analytical considerations
- Commitment to team-based collaboration, working seamlessly with broader Translational and Laboratory teams to provide highest quality scientific product for clients
- Present work internally and at national and international meetings, creating content that advances thinking in bioanalytical and biomarker communities; publish relevant manuscripts
- Serve as expert internal resource to advise on all Translational and Laboratory projects
- PhD or equivalent and 15+ years drug development experience in bioanalytical and biomarker sciences with experience in GLP and GCP environments
- Excellent verbal and written communications with demonstrated impact internally, externally and with health authorities
- Strong track record of performance in a team environment where focus is on the scientific deliverable and not individual recognition
- Demonstrated ability to think critically, with proven track record of developing fit-for-purpose strategies that deliver impeccable science without unnecessary expenditure of resources
If interested, please send CV to Info@immunologixlabs.com.