Clinical Development Senior Manager

You will support the China clinical development strategy and execution 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 under the support or supervision by Clinical Development Lead (CDL) or line manager. This includes but is not limited to contributing the China clinical development plan, study design, execution, and interpretation of key clinical studies supporting high-priority programs. The individual who assumes this high-visibility position will interact both with cross-functional teams within Biogen and with external stakeholders.

• With the support or delegation by CDL or line manager, collaborate with R&D program teams 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.
• With the support or delegation by CDL or line manager, deliver strategic leadership for study teams that integrate local knowledge in the disease area, medical community, commercial, research, and regulatory, among other key aspects.
• With the support or delegation by CDL or line manager, 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

• MD or PhD degree in life science. Experience in nephrology or immunology diseases is preferred. 
• Fluent in English and Chinese
• At least three (3) of experience in research or clinical development is desirable
• Research or clinical trial experience, particularly in development within the disease, is desirable
• 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
• Flexible and able to work in a fast-paced, rapidly changing environment

 

Job Level: Management