Schrödinger seeks a Senior Manager of Biospecimens to join us in our mission to improve human health and quality of life through the development, distribution, and application of advanced computational methods!

As a member of our Drug Discovery and Early Development team, you’ll leverage your scientific and project management skills to implement and maintain biospecimen operational plans in support of the program strategies for our clinical-staged projects spanning various therapeutics areas (e.g., oncology, immunology, etc). In so doing, you’ll maximize efficiencies through positive relationships with internal stakeholders (e.g., translational research, data management, clinical operations, clinical research, and clinical pharmacology) as well as external stakeholders (e.g., clinical sites and CROs).

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. 

• A detail-oriented, motivated, and driven biospecimen manager
• A scientific professional who can balance granular project details with larger company goals
• A problem-solver who can identify issues and propose solutions
• An energetic and innately curious team player who enjoys working across disciplines and companies

What you’ll do:

• Manage end-to-end life cycle of clinical biospecimens and associated data across multiple clinical studies 
• Assist with developing processes (such as departmental SOPs and/or Work Instructions) necessary to support streamlined chain of custody of biospecimens 
• Participate in Lab Vendor Selection process, such as RFP, proposal review, and bid defense activities 
• Review, author and edit biomarker and PK portions of key clinical documents (protocol, ICF, ethics committee documents, etc.) 
• Lead oversight of central lab development of manuals, kits, and any other biospecimen-related documents
• Develop and execute study-specific specimen management plans
• Review, author and edit lab and data specifications documents that define requirements, standards, quality control, and parameters for PK and biomarker specimen collection, handling, transportation, storage, analysis, and data delivery 
• Provide specimen collection and handling trainings at Site Initiation Visits (SIVs) and CRA training sessions
• Provide biospecimen-related documentation for the eTMF and participate in eTMF quality checks 
• Coordinate receipt and transfer of biospecimens as needed between central labs, analysis labs, and biorepository vendor 
• Reconcile biospecimen information captured across clinical study and vendor databases 
• Follow-up and resolve discrepancies by communicating with sites/CROs and vendors
• Collaborate with external labs/vendors to ensure PK and/or biomarker data are delivered in accordance with study-specific timelines (i.e., data review meetings, biomarker testing schedules, etc.) and/or SOPs 
• Identify and help resolve specimen collection, processing, transportation, and testing errors/issues as required
• Create and/or distribute specimen management metrics, listings, and reports to relevant study team members and/or in meetings as needed
• Contribute to departmental budget development and forecasting
• Approve study invoices for specimen services and track invoices against contracts
• Support end-of-study activities related to biospecimens (transfer of biospecimens to biorepository vendors, eTMF quality checks, etc.)

What you should have:

• Bachelor's Degree, preferably in a scientific discipline or health-related field 
• At least two years of relevant industry experience, including tracking/managing biospecimens and associated data in a clinical research setting
• Background in interfacing with central lab, analysis labs, and biorepository vendors
• Familiarity with CFR, ICH GCP, and other guidance related to biospecimen collection, transport, processing, handling, retention, and analysis in the context of clinical trials
• Excellent proficiency with Excel/Google sheets
• Ability to identify and resolve complex biospecimen related problems