Job Description

In alignment with ICH-GCP, China GCP, SOPs and local regulations, the Clinical Country Lead (CCL) partners with GCO, CRO and other functions to develop in-country operational plans aligned with Clinical Development Plan (global and China) and program level strategy, the CCL is accountable for delivering the studies in China within timeline and with good quality.

The CCL leverages their phase, indication and in-country operational expertise to independently oversee and take leadership for one or more clinical studies by establishing the in-country operational strategy and securing excellence in execution through the CRO partner.

• Develops and oversees implementation of China operational strategy for the successful delivery of clinical studies in China.

• Develops China Operational strategy in line with CDP and China CDP.
• Review and endorse country-level essential documents such as CSA, Country ICF, CTA and etc.
• Leverages operational expertise and scientific assessment to evaluate country/site feasibility, align with GCO on the Baseline country targe.
• Effectively leads the study via oversight of the CRO, managing performance, quality, and timelines, including defining and delivering against a baseline plan. 
• Ensures ongoing data review to identify and mitigate patient safety, study design, data integrity or study conduct issues.

Qualifications

• Educational background in science (B.A. or B.S. preferred, with an advanced degree being advantageous)
• Over 5 years of experience in project management, specifically overseeing sponsor activities in an outsourced model with CROs/vendors.
• Extensive clinical project management experience from pharmaceutical companies.
• Proficiency in English.

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.