Job title: Director of Assay Development
The successful candidate will join a multidisciplinary team of scientists working to identify, develop and validate quantitative biomarkers for tracking disease progression and for clinical applications in the context of Huntington’s disease (HD) drug discovery efforts. CHDI Foundation leads the development of Huntingtin (HTT) detection assays for preclinical and clinical applications using immunoassays, mass spectrometry and imaging (PET) strategies. In addition, we have active efforts to target DNA repair mechanisms for the treatment of HD. The Director of Assay Development will join an existing team working across the preclinical and clinical departments in support of internal and external drug development programs, liaising and partnering with external organizations.
The candidate will assume responsibility for activities to develop and optimize immunoassays for the detection and quantitation of HTT species in preclinical cell and animal models of HD. Further, the candidate will participate in optimizing and advancing HTT quantitation assays to support HTT-lowering clinical trials. In addition, as part of a larger effort to identify disease state- and disease progression-biomarkers, the candidate will explore the development and validation of other protein- or nucleic-acid based assays for clinical interrogation. Working with clinical colleagues, the candidate will work to refine and optimize biomarker strategies aimed at disease modification, in conjunction with external drug discovery companies. The position also affords the opportunity to participate in and consult with all drug discovery and development projects that could benefit from assay development skills.
The position reports to the Vice President of Biology and will based in either Los Angeles, CA or Princeton, N.J.
Qualifications and required skills
- A PhD level scientist with 5+ years of preclinical and clinical assay development experience.
- Knowledge and expertise in the fundamentals of ligand binding immunoassays and the analytical methods for ELISA, fluorescence, luminescence, and electro-chemiluminescence assays.
- Expertise in single molecule immunoassay platforms.
- Expertise working with aggregation-prone proteins.
- Ability to propose new targets for preclinical and clinical immunoassay development, ideally in the context of neuroscience applications.
- Expertise with clinical biomarker studies for neurodegenerative indications (and preferably with animal models of neurodegeneration).
- Evidence of success in immunoassay method development, qualification, validation using preclinical (rodent or primates) and clinical bio-samples.
- Expertise in GLP, CLP, CLIA and regulatory aspects of clinical assay development.
- Demonstrable evidence of interpreting biomarker changes to the underlying biology or disease processes.
- Demonstrable evidence of assay work to support brain disorder pharmacodynamic (PK/PD) studies in close collaboration with medicinal chemistry and pharmacokinetic experts.
- Demonstrable evidence of critical analysis and interpretation of data, writing technical reports, publications, IND supporting documents, and presentation to other teams and management.
- Strong communication skills and ability to interact with an international group of scientists and collaborators.
- Demonstrated ability to lead and manage projects at CROs.
Additional desired skills
- Experience in conjugation chemistry – conjugating antibodies to solid surfaces, biotinylation, process improvement methods.
- Experience with establishing production and qualification of assay reagents (e.g., antibodies and protein standards).
- Experience with nucleic acid amplification-techniques and aptamer-based assays in CSF or blood.
- Working knowledge in the area of mechanistic enzymology.
- Honest, ethical, motivated, innovative, and a team player.
- Data driven, hands-on scientist.
- Willing to engage, guide and inspire integrated teams internally and externally.
About CHDI Foundation, Inc.
CHDI Foundation, Inc. is a privately funded, not-for-profit, biomedical research organization that is exclusively dedicated to rapidly discovering and developing therapies that slow the progression of Huntington’s disease (HD). Our scientists work closely with a network of more than 600 researchers in academic and industrial laboratories around the world in the pursuit of these novel therapies, providing strategic scientific direction to ensure that our common goals remain in focus. This helps bridge the translational gap that often exists between academic and industrial research pursuits and that adds costly delays to therapy development. In its role as a collaborative enabler, CHDI seeks to bring the right partners together to identify and address critical scientific issues and move drug candidates to clinical evaluation as rapidly as possible. Our activities extend from exploratory biology to the identification and validation of therapeutic targets, and from drug discovery and development to clinical studies and trials. More information about CHDI can be found at www.chdifoundation.org
About CHDI Management, Inc.
CHDI Management, Inc. was established in 2002 to provide administrative, management and grant making services to CHDI Foundation, Inc.
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