The role (Clinical Development Senior Manager) 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 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
- Master Degree or above
- At least three (3) of experience in research or clinical development is desirable
- Research or linical 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
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.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
