seeking a highly motivated biomarker scientist to provide assay support for our clinical programs in oncology. The Clinical Biomarker Scientist will be responsible for developing and validating biomarker assays with external CLIA-certified laboratories, and subsequently implementing testing into clinical trials. Success in this role requires a thorough understanding of CLIA-grade assay validation (protein-biochemistry and molecular-based assays), and an ability to effectively manage external contract laboratories. The position requires working in close partnerships across various functions including Preclinical Research, Translational Sciences, Clinical, Biometrics, and Regulatory. In addition, the individual is expected to establish and manage productive external vendor collaborations. Effective communication is essential and can include presentations at cross-functional teams and internal review committees. Implementation of biomarker and CDx strategies into clinical studies also requires knowledge of biospecimen collection procedures. ESSENTIAL JOB FUNCTIONS • Accountable for clinical biomarker assay and clinical trial assay development and validation, as well as implementation and management of testing within clinical trials • Responsible for the successful execution of the biomarker assay development plan, including but not limited to external contract laboratory (CLIA-certified) selection, assay contract setup, analytical and communication plan preparation, database design and maintenance, logistics, and access to test results • Design and oversee fit-for-purpose assay validation • Review assay method procedures, validation reports and clinical sample analysis summary reports • Manage out-sourced testing and ensure the quality, timelines and budget are met • Responsible for writing and review of biomarker sections of clinical trial documents such as clinical trial protocols, informed consents, study procedures manuals, vendor requisition forms, eCRFs, investigator brochures, and clinical study reports • Responsible for authoring components of regulatory submissions such as Significant Risk Determination (SRD) and Investigational Device Exemption (IDE) applications, IDE Annual Reports, and Briefing Documents for Regulatory Authorities • Support CDx assay development
Development, Biology, Cell culture, Gmp, Elisa, Assay, Pcr, Molecular biology, Qpcr, Formulation, Cell biology, Mammalian cell culture, IHC, Protein Assay, Gene Expression, Immunohistochemistry Staining, Next Generation Sequencing, NGS
Top Skills Details:
ELISA, Protein Assay, Immunohistochemistry Staining (IHS)
Additional Skills & Qualifications:
• A minimum of a Masters degree with at least 4 years of combined academic institute/pharmaceutical industry experience OR a PhD in a scientific discipline (e.g. Cancer Biology, Immuno-oncology, Biomedical Science or Pharmacology) with at least 2 years of additional industry experience • Knowledge of drug discovery and development or translational medicine • Experience implementing biomarkers in a clinical setting • Direct experience in development, outsourcing and validation of clinically applicable biomarker assays in CLIA labs is required • Experience authoring SRD and IDE applications is required • Good understanding of GLP/GCP/ICH guidelines, CLIA regulations, and regulatory requirements • Experience with IHC, ELISAs, and protein assays is required • A strong applicant will also have experience with gene expression assays, qPCR, NGS, etc. • Understanding of development of a CDx a plus • Direct laboratory experience with human tissue specimens (blood, tumor etc.) is required
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.