Sr. Biomarker Consultant
10996 Torreyana Road, Suite 275 San Diego, CA 92121 US
This individual will contribute to the strategic direction of the company by leading one to several biomarker programs with an aim of identifying and developing assays required to evaluate pharmacodynamics (PD) as well as to implement clinically relevant predictive biomarkers that enrich for patients responsive to their therapeutics. Linked to this, leading companion diagnostic strategies where appropriate will also be required. Importantly, bench to bedside back to bench activities will be coordinated by this individual via collaboration with discovery colleagues. In the context of pediatric planning, participation in the pre-clinical activities supportive of the initial pediatric study plans (iPSP) for individual programs will also be necessary.
This role will require you to work from our office in San Diego, California What you'll do:
- Develop and implement a biomarker plan for individual programs that includes assay development, timelines, budget, and data output and analysis plans
- Lead all proof of mechanism activities
- Interrogate biomarker hypotheses using an array of techniques, including cell proliferation and viability assays, Western blotting, CRISPR/Cas9, Nanostring/RNASeq, siRNA/shRNA knockdown, immunofluorescence and other methods either coordinated with discovery research or through CRO outsourcing
- Identify patient selection biomarkers and strategies
- Establish and execute a companion diagnostic plan
- Coordinate time appropriate pediatric study planning
- Present data and report on project status at team, departmental, and governance meetings
- A team player with strong interpersonal skills who establishes & nurtures highly effective relationships with colleagues and key stakeholders to support and advance project goals and objectives
- Self-motivated to work effectively and collaboratively in a dynamic environment with an openness to learn new skills
- Possess strong organizational skills and be able to multi-task, to meet timelines efficiently and productively
- Ability to work independently in a dynamic and fast-paced environment
- PhD degree in cell and molecular biology or related discipline with 5+ years of biomarker related experience in industry
- Comprehensive knowledge of cancer biology and drug development
- Experience with molecular and cell biology techniques and advance data analysis tools.
- Experience with the analysis and interpretation of genomic and other datasets from preclinical and clinical samples
- Broad experience with diverse biomarker technologies including but not limited to IHC, gene expression, NGS and other genomic technologies, along with demonstrated ability to implement such technologies in the clinical setting
- Experience working in close concert with research scientists and bioinformaticians to translate hypotheses generated from preclinical and clinical samples or data sets
- Experience working on drug development teams and broad familiarity with biomarkers in early and later stage clinical development
- Ability to work closely with clinical operations to ensure implementation and collection of relevant clinical biomarker data; including contributions to clinical protocols, other regulatory documents and oversight of CRO/vendor quality.
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