Executive Director of Clinical Biomarkers

Schrödinger seeks an Executive Director of Clinical Biomarkers with expertise in hematology/oncology/immunology to join our Drug Discovery and Early Development team. By focusing on the development, delivery and implementation of clinical biomarker plans (e.g., patient selection, target engagement, pharmacodynamic and mechanistic biomarkers, etc.), this Executive Director will ensure stakeholder input and alignment, helping us identify, optimize and implement those biomarkers considered most robust, translatable, and relevant to our clinical and regulatory strategies.

Our drug discovery and early clinical development team includes a cross-functional group of scientists and drug developers with experience working on all common target classes and therapeutic areas. The group is supported by more than 100 software developers and engineers, as well as a large-scale compute infrastructure, to apply our proprietary physics-based drug design and optimization platform. Twelve of the programs we’ve worked on with collaborators have progressed into preclinical development, with nine currently in clinical trials. Additionally, certain of our wholly-owned pipeline of proprietary molecules have reached the clinic, as well. 

Who will love this job:

• An accomplished researcher who’s familiar with a wide breadth of low and medium throughput assays and methodologies to support clinical biomarker (including PK/PD relationship) discovery and validation at all stages of drug development
• A savvy scientist who’s worked on companion or complementary diagnostics
• An excellent data interpreter and presenter who’s knowledgeable about submission-level reporting and data quality standards
• An energetic team player who enjoys working across disciplines and is innately curious

What you’ll do:

• Drive cross-functional collaboration with nonclinical, translational, and clinical scientists to develop clinical biomarker plans and strategies for Schrödinger’s clinical-stage programs, working out of our Cambridge, MA facility
• Manage a small, state-of-the-art biomarker wet lab in our Framingham, MA facility.
• Lead implementation of clinical biomarker plans, including:
• Bridging preclinical PK/PD assay methodology and read-outs to an executable clinical PK/PD assay
• Identification, selection, and management of vendors appropriated to support clinical sample analysis for biomarkers
• Development/transfer of assays for clinical biomarkers at selected vendors and oversight of assay development, fit-for-purpose validation, and assay report generation
• Oversight of bioanalytical assay scientist(s) at CROs
• Clinical site education/training to ensure appropriate sample management
• Partnering with clinical operations scientists to facilitate clinical sample management and analysis in support of data generation and sample analysis reports, in accordance with agreed-upon quality standards and timelines
• Collaborate with clinical pharmacology, biostatistics, and data management scientists to ensure appropriate data analysis, reporting, and interpretation of raw biomarker data, PD and PK/PD analyses 
• Work with discovery and translational functions on proactive biomarker planning and generation of IND-enabling non-clinical data for lead clinical compounds, as well as ideating around biomarker planning for new targets
• Assist in companion diagnostic development or potential companion diagnostic partnerships to ensure that companion diagnostic assays meet all relevant regulatory requirements
• Contribute to creation of regulatory and clinical documents, posters, and publications
• Support pharmacokinetic (PK) bioanalysis of clinical samples, including both the scientific components (e.g., sample preparation, compound detection) and operational aspects (e.g., site training, PK sample collection/handling/storage/tracking and PK sample issue resolution) is desired but not required

What you should have:

• Experience in the biological or medical sciences (with a focus on biomarkers and clinical biomarker assay development and implementation) - at least eight years with an advanced degree (PhD, MD, or equivalent), or fifteen with a Bachelor’s degree
• Deep familiarity with common clinical biomarker assay platforms, including genomic, IHC, ELISA, flow cytometry, other substrate-binding or target engagement methods and cell-based ex vivo assays
• Track record of successfully developing and transitioning wet lab assays for biomarker programs to the clinic 
• Excellent understanding of the requirements for fit-for-purpose, GLP-compliant, or CLIA-compliant assay validation, and has applied these standards appropriately based on development stage and biom