At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
This position is for an Outsourcing Manager / BioMarker Operations Manager with expertise in bioanalysis and biomarker operations in Clinical Outsourcing & BioMarker Operation, 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 clinical biomarkers and bioanalytical activities for pre-clinical and clinical drug development.
Support the team on budget predictions, management and tracking for a clear understanding of the biomarker operations and their impact on the project.
Be the key point of contact for biomarker activities whether they are managed externally or internally to inform the team to make data driven decisions.
Oversee PK or ADA bioanalysis that is performed externally.
Identify and help onboard vendors for specific analysis, provide advice and support on scientific and technical aspects of analysis where possible.
Interact closely with Translational Medicine (TM) subteams to execute biomarker plans for clinical studies.
Monitor assay development, assay validation and sample analysis processes, ensure timely delivery of quality results in compliance with regulatory guidance.
Support final data import.
Interface with Central Labs and sample management team to ensure the sample logistics meet study requirements.
Work collaboratively with the CROs, ensure that all studies are managed in respect to timelines, budget, scientific integrity, 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 RFP (Requests for proposal/information), Legal Contracts, etc..
Collaborate with Quality Assurance to establish and perform audits and ensure 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 and bioanalytical technologies, and have extensive experience in clinical sample analysis. Experience in monitoring external vendor activities is a plus. They should have good knowledge of GxP and be capable of troubleshooting and identifying issues related to study activities at external vendors. They should also have excellent communication skills, and the ability to work in a collaborative environment interacting with a number of clients and support groups in order to assure streamlined processes with an emphasis on quality and timeliness. The candidate should be capable of maintaining a solid vendor relationship and ensure 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 regulated bioanalysis, 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.
#LI-Hybrid
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.