Company Description
Curis is a biotechnology company seeking to develop and commercialize innovative drug candidates for the treatment of human cancers. Our most advanced drug candidate is CUDC-907, an oral, small molecule inhibitor of histone deacetylase (HDAC), and phosphatidylinositol-3-kinase (PI3K) enzymes, which has completed the dose escalation stage of a Phase 1 clinical study. Curis is also engaged in a broad collaboration with Aurigene in the areas of immune-oncology and precision oncology. As part of this collaboration, we expect to exercise options to exclusively license small molecule antagonists of programmed death ligand-1 (PD-L1) and interleukin-1 receptor association kinase-4 (IRAK4) and file IND applications for both molecules.
Our most advanced program, a Hedgehog pathway inhibitor program developed in collaboration with Genentech (Roche), led to the commercialization of Erivedge® (vismodegib), the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma. Genentech/Roche are responsible for the development and worldwide commercialization of Erivedge. Roche and Genentech are also continuing Erivedge®’s clinical development in less severe forms of BCC as well as planned development in other non-oncology indications.
Our corporate culture is focused on learning and growing in a challenging environment with a committed group of peers working together as a team. For more information, visit Curis' website at www.curis.com.
Clinical Sample Operations Manager
Position:
- Plans and coordinates all operational activities required for the collection, delivery and testing of clinical biomarker or diagnostic samples within a clinical study.
- Works closely with Scientists to execute exploratory and Companion Diagnostic biomarker strategy.
- Creates synergies across studies within each project by providing oversight throughout biomarker operations.
- Aligns processes surrounding vendor selection and management
- Develops project specific tools and documents to streamline activities
- Acts as the primary point of escalation for issue resolutions
- Evaluates resourcing needs
- Supports recruitment of new personnel
Primary Responsibilities and Accountabilities:
- Responsible for the development and implementation of the clinical biomarker operations strategy, including CRO management, lab manual generation, sample collection and shipping logistics, and budget, etc.
- Provides input on Protocol and ICF development
- Identifies novel and innovative clinical sample collection and processing techniques and ensures logistical feasibility
- Manages timelines for sample testing and data transfer with both internal testing labs and external vendors
- Single point of contact for status of clinical trial samples and biomarker data
- Manage sample transfer/discrepancy resolution with Central Lab and other sample analysis/storage CROs
- Provide sample and assay status updates
Qualification
- M.Sc. or higher degree with 3 to 5 years of industry experience is required
- Biological laboratory experience with evidence of involvement in the processing and analysis of biological samples is strongly preferred
- Familiar with technologies used in clinical sample analysis, including but not limited to protein, DNA and RNA analysis
- Prior experience in clinical sample operations is preferred
- Detail oriented with the ability to work independently and manage multiple projects simultaneously
- Excellent verbal, written and presentation skills
- Proven ability to work successfully under pressure
- Ability to work in a multifunctional team environment, interact with a wide variety of internal and external customers and relate effectively to people at all levels of the organization
Please send CV with job code (CSM200) to:
Human Resources, Curis, Inc.
4 Maguire Rd.
Lexington, MA 02421
Email: jobs@curis.com or Fax: 617.503.6501.
No phone calls please.
Curis, Inc. is an Equal Opportunity Employer.