Rubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics™. Our proprietary RED PLATFORM® was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Our therapies can potentially be used to kill tumors in cancer and to regulate the immune system for the treatment of autoimmune diseases. Our IND for RTX-240, our first oncology candidate for the treatment of solid tumors, has been cleared by the FDA. Additionally, we plan to file an IND for RTX-321 for the treatment of HPV-positive tumors by year-end.
We are proud of our passionate, high-performance culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2013, we are based in Cambridge, MA and currently expanding across all functions within the organization. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com
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Translational Medicine (TM) is part of the Clinical Development organization and plays a pivotal role in bringing innovative medicines to patients. The Translational Medicine Senior Manager will lead biomarker operations for clinical trials and will serve as a key contributor to TM and Clinical Teams. The ideal candidate for this position will provide support for clinical biomarkers assay outsourcing (PK, ADA, PD, Biomarkers, Exploratory), strategic vendor management, operational planning, and support of clinical studies including sample management/monitoring. This role embraces the principles of a translational medicine mindset, with a focus on operational excellence. The ideal candidate will have a passionate desire to help transform current treatment paradigms while working in an innovative and fast-paced environment.
Qualifications & Education
- Lead clinical assay and biomarker (PK, PD, ADA, biomarkers) outsourcing for multiple biomarker modalities (e.g., qPCR, Immunoassay, Flow cytometry, LC-MS, IHC, RNA expression profiling, etc.) including operational support for vendor lead activities, data transfers, data flows and ensure quality and timely deliverables.
- Oversee development of outsourced assays with support from technical SMEs.
- Serve as the Subject Matter Expert in operational aspects of outsourcing of clinical biomarkers in support of clinical studies. Independently identify, and resolve complex issues, sample management, Vendor quality or performance issues and engage technical SME, Translational Medicine, clinical trial leaders, and data management as needed.
- Support clinical studies and contribute to clinical teams including clinical study protocol, site operations manuals, informed consent forms, sample collection tables, instruction manual, central lab protocol/manual, and other biomarker study setups.
- Lead strategic global vendor management including vendor benchmarking, partnership with Business Sourcing, partnership with Line Functions (e.g. Research, CMC, TM, Clinical Operations, other), and negotiations with external service providers (ESP) to ensure strategic alignment.
- Serve as Translational Medicine Manager in clinical studies and contribute to the biomarker planning and operational execution.
- Provide operational/logistics support for the clinical trial as it relates to Translational Medicine and Biomarkers
- Review study concept sheet, clinical study protocol, and schedule of assessments for biomarkers (PK, ADA, PD, BMs) related sections (operational/logistics input).
- Coordinate the biomarker costs and coordinate the input from various types of sampling and assessments provided by SMEs.
- Contribute to site feasibility.
- Prepare and/or review of optional Genetic ICF, review the PK, PD, ADA, Biomarkers related sections of main ICF and review site-specific changes related to Biomarker assessments.
- Prepare the sample collection table for biomarker samples (coordinating input from SMEs)
- Prepare the biomarker lab instruction manual for all biomarker samples (coordinating input from PIs)
- Work with the clinical team to operationally set up the central lab for biomarker assessments (e.g. sample processing instructions, materials, kits, labeling, storage, etc.)
- Review of biomarker related sections of central lab protocol and the study eCRF
- Coordinate sample logistics for all clinical biomarkers under TM responsibility
- Support operational inquiries regarding sample logistics of TM biomarkers throughout study
- Coordinate Biomarker Study Coordination for study close-out activities
- BS/BA, MS, PharmD in life sciences with 5-10 years of operational and scientific experience in supporting translational medicine and biomarker activities during clinical trials.
- Good understanding of the biopharmaceutical environment and biomarker implementation process in the early stage of drug development.
- Solid understanding of validation/qualification requirements for PK. PD, ADA, biomarkers assays to support clinical studies.
- Ability to review and summarize complex data sets
- General knowledge of biomarker discovery methodologies (molecular biology).
- Experience in supporting clinical trials and working as part of the clinical study team.
- Working knowledge of clinical trial conduct and Good Clinical Practice (GCP).
- Ability to work in teams and function in a cross-functional organization.