Employer: Biogen
Location: Shanghai, China
Region: APAC
Department: Research & Development
Job Type: Full-time
As a Clinical Development Lead, you will support the China clinical development strategy for assigned programs. This role involves interfacing with Global product teams and China cross-functional teams to prioritize Biogen’s portfolio from a China perspective. You will play a key role in ensuring the implementation aligns with Biogen’s integrated global strategy.
This position involves:
Strategic design, execution, and interpretation of key clinical studies.
Submission dossier review for high-priority programs.
Collaboration with internal and external stakeholders to drive clinical development success.
Collaborate with R&D Development Asset Team (DAT), Study Management Team (SMT), and China cross-functional teams.
Integrate scientific rationale, regulatory requirements, and commercial goals into China’s clinical development strategy.
Deliver strategic leadership for study teams, incorporating local knowledge on disease areas, medical community, regulatory environment, and commercial aspects.
Provide clinical oversight for all relevant studies in China.
Focus on study preparation, execution, and ongoing medical data review to ensure data integrity.
Analyze and interpret clinical data to guide decision-making.
Contribute to the development of clinical trial protocols, Clinical Study Reports (CSRs), and submission documents.
Engage Key Medical Experts (KMEs) and external experts to review, analyze, and communicate scientific and medical knowledge.
Communicate with China’s Center for Drug Evaluation (CDE) as needed, ensuring Biogen’s interests are represented.
Escalate critical regulatory matters to internal partners/stakeholders.
Master’s degree required.
5-10 years of clinical drug development experience, particularly in CNS or immunology diseases.
Strong ability to analyze and present clinical data.
Excellent communication and organizational skills (oral & written).
Ability to represent China’s perspective on project teams, committees, and external meetings.
Experience working effectively in cross-functional teams and decision-making processes.
Proven ability to direct clinical development plans in a collaborative manner.
Strategic thinker, open-minded, and adaptable to change.
Flexible and able to work in a fast-paced, rapidly changing environment.
At Biogen, we combine global impact with an inclusive, innovative culture. As a mid-sized biotechnology company, we offer the stability and resources of a well-established business while ensuring that individual contributions make a significant impact.
We foster:
Learning, growth, and career development opportunities.
A strong commitment to diversity, equity, and inclusion (DE&I).
A collaborative environment where every role plays a vital part in delivering life-changing medicines.
Our Values:
✔ Caring Deeply
✔ Achieving Excellence
✔ Changing Lives
To learn more about our DE&I initiatives, visit Biogen's website.
If you are located in Mainland China, your personal data (name, email, country, phone number) will be transferred to Biogen Inc. (US) for HR management and business communication.
For privacy-related concerns, contact: privacy@biogen.com.
Join Biogen and make a difference in clinical development. Apply today!
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Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
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Haarlem |South Holland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
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Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
Springville | Belgium | Xzagreb | Slovakia | Bountiful | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Castlebar | Lenexa | Leinster | Nairobi | Riga | McFarland | Remote - Europe | Lousiana | Ireland | Green Way | Texas | Faridabad | Blue Bell | Remote, USA | Switzerland | Manipal | Medan | Tulsa | French | Victoria | Zaragoza | Remote - South America (Latin Americal) | Minnesota | Hungary | Remote - Africa | Melbourne | Remote - Middle East | Thailand | Remote | Hammond |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
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Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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