Senior Scientist, Oncology Biomarkers
July 31, 2014
The Senior Scientist, Oncology Biomarkers will be responsible for the development and implementation of biomarker and diagnostic strategies to enable and support the discovery, development and commercialization of medically-differentiated therapies in Oncology. This person will lead the development and implementation of biomarker and diagnostic strategies for individual projects in Oncology. He/she will provide expertise to discovery and development project teams to ensure access to state of the art thinking on appropriate biomarker and diagnostic technologies, evaluate their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarker and/or diagnostic assays. In addition, he/she will direct the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers) and design, implement and oversee biomarker and diagnostic testing and data analysis.
• Lead biomarker and diagnostic strategy development and execution for individual research and development projects.
• Provide input on biomarker and diagnostic related sections of clinical study protocols, clinical study reports, statistical analysis plans, laboratory manuals, etc.
• Support drug and/or companion diagnostic filing and registration activities, including:
- interpretation and preparation of biomarker results needed for filing purposes
- contribution to preparation of documents required for drug and/or companion diagnostic registration
- participation in meetings with regulatory agencies and providing technical expertise as needed
• Design, implement and oversee biomarker and diagnostic testing and data analysis
• Direct the development, outsourcing and validation of clinically applicable BM assays
- Design, implement and monitor biomarker and diagnostic testing and data collection
- Collaborate with biostatistics and bioinformatics colleagues to design data analysis plans
- Interpret and communicate biomarker and diagnostic results for informed decision-making
- Utilize biomarker approaches to investigate the mechanism of action of therapeutics in development to generate insights that can be leveraged in drug discovery and novel target identification
• Present to and participate in Advisory Boards and KOL meetings as needed
Essential Duties and Job Functions:
• Actively participates in and may lead the development and implementation of biomarker and diagnostic strategies for individual projects
• Manages the development, outsourcing and validation of clinically applicable biomarker assays including pharmacodynamic, predictive, prognostic, safety and other biomarkers
• Oversees biomarker and diagnostic testing and complex data analysis; closely works with multiple departments including research, clinical operations, data management, and biometrics to ensure complete implementation of biomarker strategies
• May be required to participate hands-on in the lab to facilitate and assist with biomarker assay development and/or validation
Knowledge, Experience and Skills:
• PhD in Cancer Biology, Cell Biology, or Molecular Biology or related field and a minimum of 7 years of relevant research experience. Must have expertise in one or more of the following therapeutic areas: oncology, hematology, immunology, or inflammation.
• Experience with the discovery, characterization, clinical validation and utilization of innovative biomarkers and potential diagnostics.
• The applicant must have experience implementing biomarkers in clinical studies
• Direct experience in development, outsourcing and validation of clinically applicable biomarker assays is required
• Direct laboratory experience with ELISA, flow cytometry, and human tissue specimens (blood, etc.) is required
• A strong applicant will also have experience with gene expression microarrays, qPCR, comparative genomic hybridization, and protein arrays
• Excellent verbal communication and interpersonal skills are required.
• The applicant must be able to multi-task and participate effectively in teams
• Excellent leadership skills including motivation and delegation
• Strong motivation, attention to detail, and ability to think independently and fully integrate into a high achieving team environment
• Must be able to work effectively on multiple oncology programs in a fast paced environment
• Must be able to work independently with minimal supervision
• High level of business awareness