Job title : BioMarker Operations Manager

  • Location: Shanghai / Suzhou

About the job

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 TMED team as a BioMarker Operations Manager and you’ll bridging of China clinical development project teams and global TMED subteams to support the externalization and operationalization of clinical biomarker and bioanalytical activities for clinical drug development.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

This position is for an Outsourcing Manager / BioMarker Operations Manager with expertise in bioanalysis and biomarker operations in TMED (translational medicine and early development) China. 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

  • Experience :

  • With at least 5 years in a pharmaceutical environment, preferably with some experience in regulated bioanalysis, clinical biomarkers or a related area.

  • Soft skills :

  • 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.

  • Be capable of maintaining a solid vendor relationship and ensure that the needs of the study are satisfied and appropriately managed.

  • Technical skills :

  • Have a good understanding of biomarker and bioanalytical technologies

  • Have demonstrated experience in clinical sample analysis.

  • Experience in monitoring external vendor activities is a plus.

  • Have good knowledge of GxP and be capable of troubleshooting and identifying issues related to study activities at external vendors.

  • Education :

  • Master degree with at least five years relevant working experience, or

  • Bachelor degree in biology or related disciplines with extensive practice working experience

  • Languages : English and Mandarin.

Why choose us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.

  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Pursue Progress . Discover Extraordinary .

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !