Job Description

As China Biomarkers & Diagnostic Lead, you are the key responsible person for China biomarker & genetics study planning, assay platform and parameter establishment to enable China development programs.

You are responsible for aligning clinical biomarker & genetics plan with global biomarker team. Accountable for vendor selection, qualification & monitoring and serve as China biomarker lead in CPT and SMT teams, reesponsible for technical and logistical management of selected CROs, including final data QC; responsible for the authoring and/or reviewing of all relevant biomarker documents including briefing book, protocol, ICF, CRO MSA/SOW, HGRAC application, and analytical report.

You are also responsible for technical evaluation of IVD partners and oversight of IVD assay development.

• key responsible person for project biomarker/genetics plan development with global Biomarker function. Serve as China biomarker lead in China Project Team (CPT).
• Responsible person for the authoring and review of the key documents including but not limited to briefing book, study protocol, ICF, CRO MSA/SOW, HGRAC application, and study report. Serve as project China Biomarker Lead in Study Management Team (SMT).
• Responsible for technical evaluation and qualification of local biomarker & genetics vendors.
• Responsible for assay transfer, validation/cross-validation and trial sample testing. Responsible for technical oversight of selected CROs, including final data QC to ensure timely and quality biomarker data delivery
• Responsible for the due diligence of China Biomarker/Genetics related regulation/guideline,  Biomarker/IVD partner searching and other information that required by line manager. Support Biomarker & Bioanalytical related interaction with China health authorities.

Qualifications

• PhD in molecular biology or molecular immunology is preferred.
• 5-10 years of direct industry experience in clinical biomarkers/genetics and in vitro diagnostic methodology, or other roles involving significant technical development.
• Extensive hands-on experience in biomarker/bioanalytical technologies, including but not limited to flow cytometry, immunoassay, PCR, and next generation sequencing (NGS)
• In-depth knowledge of assay development and validation. Familiar with biomarker lab and clinical assay regulatory requirements in China and global.
• Proven experience developing biomarker/IVD plan and assay platforms in drug or Dx development programs.
• Excellent communication and CRO lab management skills.
• Self-motivated and proven ability to work with cross-functional and geographically dispersed stakeholders.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

Where you are located in Mainland China and the Personal Information Protection Law (“PIPL”) applies, for the purposes of conducting recruitment and HR management within China and having business communication and cooperation with the Overseas Recipient, we will transfer your personal data (including name, email address, country, phone number) to Biogen Inc (the “Overseas Recipient”) in the US (with the contact details and channel for exercising data subject rights at privacy@biogen.com) via Public Internet and Private Internet. The Overseas Recipient will collect, store, use and entrust information system service providers to process the Personal Data for the purposes of conducting unified HR management of the Biogen Group, internal cross-border communication of the Biogen Group, unified compliance management of the Biogen Group and providing information system technical services to the Biogen Group.