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.
Who will love this job:

• 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

Pay and perks:
Schrödinger understands it's people that make a company great. Because of this, we're prepared to offer a competitive salary, equity-based compensation , 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 regular catered meals in the office, a company culture that is relaxed but engaged, and over a month of paid vacation time. Our Office Management team also plans 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 included in Crain's New York Best Places to Work, BuiltIn's NYC Best Place to Work, and Newsweek's list of America's 100 Most Loved Workplaces.
Estimated base salary range: $150,000 - $200,000. Actual compensation package is dependent on a number of factors, including, for example, experience, education, degrees held, market data, and business needs. If you have any questions regarding the compensation for this role, do not hesitate to reach out to a member of our Strategic Growth team.
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, sexual orientation, or any other protected characteristic. 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.