The successful candidate will play a pivotal role in Spectrum’s research and development activities. This position is responsible for devising and leading the implementation of biomarker and diagnostic strategies by guiding the characterization of mechanism of action in clinical trials and the assessment of potential correlates of response with our novel drug candidates.
- Lead execution and integration of cutting-edge tumor tissue-and plasma based assay technologies (eg IHC, ISH, Multiplex IF/IHC), digital image analysis, genomic assays (eg NGS, RNASeq, PCR, ctDNA), and computational biology for the develop clinical oncology biomarkers.
- Subject matter expert for the development of companion diagnostics (CDx) platform by managing external vendors
- Independently formulate translational research strategies by designing, developing and implementing the use of biomarkers in preclinical research and clinical trials.
- Aid in the in-license, design, implementation and completion in the discovery and development of novel therapeutics in the oncology field.
- Establish as appropriate internal biomarker capabilities and outsourcing of biomarker assays, leading these efforts across development programs
- Lead external collaborators (both corporate and academic) on preclinical and clinical biomarker activities to advance Spectrum’s R&D oncology programs.
- Ensure that all studies are performed in timely manner with appropriate scientific rigor and appropriate documentation.
- Be an integral part of a collaborative and dynamic team responsible for advancing the company’s discovery research and preclinical- and clinical development plans.
- Strong organizational and time-management skills including the ability to manage several projects simultaneously.
- A strong entrepreneurial spirit and a desire to be hands on.
- Strong analytical and critical thinking skills, and attention to details.
- Demonstrated creativity in problem solving.
- Ability to effectively collaborate as part of cross-functional teams and with research partners.
- Excellent professional interpersonal skills, particularly oral and written communication skills and be able to work in a multidisciplinary team environment.
- Working knowledge of regulatory/guidance requirements (i.e. GLP, FDA, EMA) best practices in biomarker development and risk assessment based on target indication.
- Proven track record of scientific accomplishments demonstrated by publications in peer reviewed journals.
Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color. Religion, sex, national origin, disability, veteran status, and other protected characteristics.
- Deep understanding and experience in translating disease biology and the pharmacology of NCEs into clinical biomarker strategies which impact clinical decision-making.
- Ability to develop a comprehensive precision oncology strategy for diagnostic and prognostic biomarkers for current and future targets (including patient selection and CDx development).
- Direct experience in the development of in vitro diagnostics and ideally with companion diagnostics with an understanding of the current and evolving global regulatory environment.
- PhD with a minimum of 5 years of post-doctoral training in academia or industry. Also required is at least 3 years’ experience in the field of translational science. Experience with the precision oncology approach and the development of CDx is a plus with a proven track record of scientific achievement illustrated by publications/patents/IND/NDA filings