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BioMarker Operations Manager

Synthorx

Synthorx

Operations
Multiple locations
Posted on Friday, May 31, 2024

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Translational Medicine team as a Biomarkers Operations Manager and you'll be supporting the Clinical Outsourcing and TMED divisions with your talents in bioanalysis and biomarker operations.

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

About you:

  • 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.
  • Good understanding of biomarker and bioanalytical technologies
  • Extensive experience in clinical sample analysis
  • Good knowledge of GxP and be capable of troubleshooting and identifying issues related to study activities at external vendors.
  • 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.
  • Capable of maintaining a solid vendor relationship and ensure that the needs of the study are satisfied and appropriately managed.
  • Experience in monitoring external vendor activities is a plus.

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

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!