Principal Scientist, Biomarker Lead / Translational Scientist
Celsius Therapeutics is a biotechnology company developing novel precision medicines autoimmune disease and cancer by harnessing the power of single cell RNA sequencing and human biology at scale. We are a community of scientists and business professionals aspiring to develop life-changing precision medicines. Our common goal is to markedly improve human health by integrating data, experience and insight. Our environment is rigorous, fast-paced and collaborative, bringing together passionate individuals who are making an impact. We inspire creativity and discovery by embracing an open culture that fosters innovation, teamwork, and excellence. The company’s first therapeutic candidate is an anti-TREM1 antibody for the treatment of inflammatory bowel disease, and the company has multiple ongoing drug discovery programs in oncology.
We seek a highly creative and experienced biomarker lead to and translate these assays into clinical trials. In collaboration with the project teams, you will define the strategy for development of scientifically rigorous translational and exploratory biomarker strategies that enable patient selection and/or assess proof of mechanism, target engagement, exploratory signs of efficacy.
- In collaboration with the project teams, define the strategy for development of scientifically rigorous translational and exploratory biomarker strategies that enable patient selection and/or assess proof of mechanism, target engagement, exploratory signs of efficacy
- Drive method development and method transfer of internally developed assays to external vendors to ensure compliance and high quality data. Partner with CROs to ensure successful transfer and validation for use in clinical trials
- Evaluate CROs for their ability to execute biomarker plans in the clinic
- Support clinical studies as a biomarker lead, overseeing work by CROs to ensure quality execution and analysis, including managing and monitoring sample collection and analysis, and coordinating data analysis, interpretation and reporting of results
- Support scientific input and review of all biomarker aspects of clinical and regulatory documents for early stage programs, including but not limited to study protocols
- Requires an advanced degree (PhD, MD) in life sciences or related area with significant prior experience (7+ years) or Masters degree (with 12+ years experience) in biomarker strategy and assay implementation.
- Experience in PD biomarkers required, experience with patient selection biomarkers including CDx preferred
- Demonstrated success in collaborating with CROs
- Successful assay development for novel biomarkers and transfer to the clinic, including method development, method transfer and validation
- Demonstration of use of biomarkers in a clinical setting, translation from pre-clinical to clinical studies
- Demonstrated strong leadership, collaboration, and communication skills. Must be self-aware, inspiring, and able to skillfully bring people together to accomplish ambitious goals.
Celsius Therapeutics, Inc. is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, status as a veteran or as a member of the military or status in any group protected by applicable federal or state laws.