Schrödinger is seeking a Director of Clinical Biomarkers with expertise in hematology/oncology 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 individual 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. Ten of the programs we’ve worked on with collaborators have progressed into preclinical development, with four currently in clinical trials.
- Drive cross-functional collaboration with nonclinical, translational, and clinical scientists to develop clinical biomarker plans
- Lead implementation of clinical biomarker plans, which includes:
- Identification and selection of vendors appropriate to support clinical sample analysis for biomarkers, and for PK (desirable but not required)
- Development/transfer of assays for clinical biomarkers at selected vendors and overseeing assay development, fit-for-purpose validation, and assay report generation
- Oversight of bioanalytical assay scientist(s) at CROs in their work to develop and validate assays, and test samples in support of clinical pharmacokinetic data (desirable but not required)
- Clinical site education/training to ensure appropriate sample management (e.g., collection, handling and storage)
- Collaboration 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 early-stage compounds
- Aid in companion diagnostic development or potential companion diagnostic partnerships
- Contribute in the creation of regulatory and clinical documents, posters, and publications
- Serve as a resource for development of biomarker plans and assays for potential and late-stage discovery and early development candidate-stage programs
- 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.
Essential Qualifications and Experience:
- Extensive background in the biological or medical sciences with a focus on biomarkers and clinical biomarker assay development and implementation; at least eight years of experience with an advanced degree (PhD, MD, or equivalent) OR at least fifteen years of experience with a Bachelor’s
- Knowledge of and experience with common clinical biomarker assay platforms, including genomic, ELISA, flow cytometry, other ligand-binding methods, and cell-based ex vivo assays
- Understanding of requirements for fit-for-purpose, GLP-compliant, or CLIA-compliant assay validation and experience applying these standards appropriately based on development stage and biomarker status in the program
- Familiarity with submission-level reporting and data quality standards, with extensive experience in the selection and oversight of assay vendors to support national and global clinical trials.
- Familiarity with genomic assays and methodologies
- Outstanding presentation, data interpretation and communication skills
- Experience managing external teams at CROs
- Comfort working across a number of disease areas and ability to shift gears quickly
- A creative and resourceful spirit in the face of scientific uncertainty
- Oncology or immunology training strongly preferred
- Working knowledge of bioanalytical assay methodology and regulatory requirements for GLP bioanalysis of small molecules
- Experience working on companion diagnostics