About

Our Guiding Principles

Commitment, Excellence and Collaboration

To transform patients’ lives through our commitment to deliver end-to-end excellence to our partners by leveraging a unique blend of deep scientific expertise and a differentiated holistic approach towards problem solving and collaboration.

With our guiding principles as our compass we are positioned to advance impactful therapies to patients together!

Hi, I am Monica Einstein, PhD., Founder and Owner

Hi, I am Monica Einstein, PhD, founder of Einstein Biomarker Solutions, LLC

Monica Einstein, PhD in Cellular, Developmental and Molecular Biology at Rutgers University/Robert Wood Johnson Medical School, Cancer Biology and Therapeutics (1yr+) Program Graduate with Honors, Certificate from Harvard Medical School

We provide expert scientific and strategic consulting services on drug development, biomarkers, diagnostics, and medical affairs to life science companies, investors, and pro bono services. 

Dr. Einstein brings a differentiated end-to end 25+ years drug development experience across academia, pharma, biotech, specialty biomarker and clinical trial CROs partners. Her breadth of experience spans drug discovery, translational medicine, clinical development and medical affairs with a track record of delivery results, including the approval of several drugs and diagnostics. 

Monica offers deep scientific expertise across therapeutic areas (Oncology, Cardiovascular Diseases, Neuroscience, Diabetes and immunology) empowered by a unique, holistic approach integrating cross-functional and external inputs from the medical, regulatory, and commercial landscape to deliver life science solutions to our partners that are timely and cost-effective.

Dr. Einstein has served in multiple leadership roles and has led cross-functional discovery, biomarker and CDx teams to develop research operating plans, biomarker and CDx strategies including operational requirements for optimal execution of these plans in a clinical trial research setting. This work encompassed the assay development and validation of several assays across different technologies (genomic, IHC and immunoassays) and writing biomarker/CDx sections in protocols, protocol concepts and regulatory documents.

Monica’s various roles in Global/US medical affairs has uniquely positioned her to develop integrated Biomarker/CDx and medical affairs strategies, by including the voice of the external medical community to assess the feasibility of implementing diagnostics and new therapies in clinical practice.

Our clients: Flagship Pioneering and several investor firms

Einstein Biomarker Solutions LLC, is energized to welcome new partners in the life science industry, investors and nonprofits to make a difference for patients. Let's connect!