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.
location: Philadelphia, Pennsylvania
job type: Contract
salary: $65 - 75 per hour
work hours: 9 to 5
- 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
- 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 research or 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
- Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously
- Must have excellent written and verbal communication and interpersonal skills and must be able to operate in a fast paced and dynamic environment
skills: Assay Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.