Clinical Development Lead

Job Description

You will support the China clinical development strategy for assigned programs, activities include interfacing with the Global product teams and China affiliate cross-functional teams to prioritize the Biogen portfolio from a China perspective and ensure implementation is aligned with an integrated global strategy. This includes but is not limited to supporting the strategic design, execution, and interpretation and submission dossier review of key clinical studies supporting high-priority programs. In this high-visibility position, you will interact with both cross-functional teams within Biogen and external stakeholders.

• Collaborate with R&D Development Asset Team (DAT), Study Management Team (SMT) and China cross-functional teams to integrate scientific rationale, regulatory requirements, product development plan, and commercial goals for a solid strategic framework and plan for China.
• Deliver strategic leadership for study teams that integrate local knowledge in the disease area, medical community, commercial, research, and regulatory, among other key aspects.
• Provide clinical oversight across all relevant studies and programs in China, focusing on study preparation and execution, ongoing medical data review to ensure data integrity, and review and interpretation of data.
• Provide scientific input and contribute to the creation of relevant clinical deliverables, such as clinical trial protocols, Clinical Study Reports (CSRs) and submission summary/HA response document, ensuring high quality, accuracy and consistency with overall program goals and CDP.
• Engage KMEs, external experts to accumulate, review, analyze and communicate scientific and medical knowledge necessary to support clinical development.
• Communicate with CDE as needed, representing the interests of Biogen and patients, escalating matters in a timely manner to the appropriate internal partners/stakeholders.  

Qualifications

• Master Degree
• 5-10 years of clinical drug development experience, particularly in CNS or immunology diseases
• Ability to analyze and present data
• Excellent communication and organizational skills (oral and written)
• Ability to represent China’s perspective on project teams, committees, and external meetings
• Ability to work effectively in a cross-functional setting and use a team approach to decision making
• Proven ability to work collaboratively with colleagues to direct clinical development plan
• Strategic thinking, and open-minded
• Flexible and able to work in a fast-paced, rapidly changing environment

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.