Clinical Development Lead
Clinical Development Lead
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Job Description
You will support the China clinical development strategy for assigned programs activities include interfacing with the Global product teams and China affiliate crossfunctional 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 and interpretation and submission dossier review of key clinical studies supporting highpriority programs. In this highvisibility position you will interact with both crossfunctional teams within Biogen and external stakeholders.
- Collaborate with R&D Development Asset Team (DAT) Study Management Team (SMT) and China crossfunctional 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 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
- 510 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 Chinas perspective on project teams committees and external meetings
- Ability to work effectively in a crossfunctional setting and use a team approach to decision making
- Proven ability to work collaboratively with colleagues to direct clinical development plan
- Strategic thinking and openminded
- Flexible and able to work in a fastpaced rapidly changing environment
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 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 crossborder communication of the Biogen Group unified compliance management of the Biogen Group and providing information system technical services to the Biogen Group.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
