Senior Director of Clinical Biomarkers
Schrödinger seeks a Senior 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 Senior 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. Ten of the programs we’ve worked on with collaborators have progressed into preclinical development, with four currently in clinical trials.
Who will love this job:
- An experienced manager of pharmacokinetic (PK) bioanalysis of clinical samples
- An accomplished researcher who’s familiar with genomic assays and methodologies
- A savvy scientist who’s worked on companion diagnostics
- An excellent data interpreter and presenter who’s knowledgeable about submission-level reporting and data quality standards
- A fantastic team player who enjoys leading multidisciplinary teams, working across disciplines and has a strong working knowledge of bioanalytical assay methodology and regulatory requirements for GLP bioanalysis of small molecules
What you’ll do:
- Lead multidisciplinary teams of nonclinical, translational, and clinical scientists
- Drive cross-functional collaboration to develop clinical biomarker plans and strategies for Schrödinger’s clinical-stage programs
- Lead implementation of clinical biomarker plans, including:
- Identification and selection of vendors appropriate 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 early-stage compounds
- 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
- Take a leading role in recruiting, overseeing and guiding earlier career translational scientists in the fulfillment of these responsibilities
What you should have:
- Experience in in the biological or medical sciences (with a focus on biomarkers and clinical biomarker assay development and implementation) - at least twelve years with an advanced degree (PhD, MD, or equivalent), or eighteen with a Bachelor’s
- Deep familiarity with common clinical biomarker assay platforms, including genomic, ELISA, flow cytometry, other ligand-binding methods and cell-based ex vivo assays
- 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 biomarker status in the program
Pay and perks:
Schrödinger understands it’s people that make a company great. Because of this, we’re prepared to offer a competitive salary, stock options, and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, a flexible work schedule, and a parental leave program. We have catered meals in the office every day, a company culture that is relaxed but engaged, and over a month of paid vacation time. Our Administrative and Human Resources departments also plan a myriad of fun company-wide events. New York is home to our largest office, but we have teams all over the world. Schrödinger is honored to have been selected as one of Crain's New York Best Places to Work for the past three years running.
Sound exciting? Apply today and join us!
As an equal opportunity employer, Schrödinger hires outstanding individuals into every position in the company. People who work with us have a high degree of engagement, a commitment to working effectively in teams, and a passion for the company's mission. We place the highest value on creating a safe environment where our employees can grow and contribute, and refuse to discriminate on the basis of race, color, religious belief, sex, age, disability, national origin, alienage or citizenship status, marital status, partnership status, caregiver status, sexual and reproductive health decisions, gender identity or expression, or sexual orientation. To us, "diversity" isn't just a buzzword, but an important element of our core principles and key business practices. We believe that diverse companies innovate better and think more creatively than homogenous ones because they take into account a wide range of viewpoints. For us, greater diversity doesn't mean better headlines or public images - it means increased adaptability and profitability.