Bridgewater, New Jersey, Framingham, Massachusetts
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This position is for a BioMarker Operations Manager with expertise in biomarker and bioanalysis in Outsourcing and Study Monitoring, Project Operations in TMED (translational medicine and early development). The main responsibilities include:
- Act as the project manager to support the externalization and operationalization of biomarkers and bioanalytical activities that are part of clinical programs
- Help support the team on the Budget predictions, management and tracking for a clear understanding of the Biomarker analysis and it’s impact to the project.
- Be the key point of contact of the updates for ALL biomarker activities for a program whether they are managed externally or internally to allow the team to be informed and make data driven decisions
- Identify vendors for specific analysis, provide advice and support on scientifc and technical aspects of analysis where possible
- Interfacing with Central Lab Project Managers and sample management to ensure the specifics to the logistics of sample support
- Support translational subteam of clinical projects with timelines and delivery of information
- Support the BioMarker and Clinical Bioanalysis lead with logistics and scientific interfaces and discussions
- Interact closely with SANOFI TM Subteams teams responsible for the activities that are externallycontracted
- Monitor assay development, assay validation and sample analysis process, ensure timely delivery of quality results in compliance with regulatory guidance and SANOFI BTDs
- Support the teams on importation or management of finalized data for analysis for clinical support
- Support the team on the oversight and analyis of any PK or ADA activities that have also been managed externally
- Work collaboratively with the CROs, assure that all studies are managed in respect to timelines, budget and quality deliverables
- Assure all aspects necessary for contracting studies are in place. This includes developing and maintaining a strong working relationship with Purchasing, Legal and other support functions to provide RFQ (Requests for quotes/information), AEDs, Legal Contracts, etc..
- Monitor studies for their progress and quality related to the scientific integrity
- Collaborate with Q&C to establish and perform audits and assure that selected CROs respect the quality assumed by SANOFI
- Interact with Regulatory Agencies and CROs to support regulatory inspections
The candidate should have a good understanding of biomarker technologies and experience in monitoring studies in biomarker analysis of clinical samples. They should have good knowledge of GxP and CLIA concerns and capable of troubleshooting and identifying issues related to overseeing study activities at external vendors. They should also have project management experience and the ability to work in a collaborative environment interacting with a number of clients and support groups in order to assure streamline processes with an emphasis on quality and timeliness. The candidate should be capable of maintaining a solid vendor relationship and assuring that the needs of the study are satisfied and appropriately managed.
- The candidate should have a degree in biology or related disciplines; with at least 5 years in a pharmaceutical environment, preferably with some experience in clinical biomarkers or a related area.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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