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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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Baddi | Solan |India :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
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Bridgeport | Bristol | Enfield | Groton | Hartford | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Boca Raton | Brooksville | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
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Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Leiden |North Yorkshire :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Richmond Hill | Renfrew | Uxbridge | North York | Mississauga |Quebec :
Montreal |Chile :
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Croatia |Zagreb :
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Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Tel Aviv | Netanya | Yavne | Be'Er Sheva |Italy :
Italy |Lombardy :
Rho |Japan :
Saitama | Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
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Ciudad de México |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
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Warsaw |Remote :
Remote - Africa | Remote, USA | Remote | Remote - Europe | Remote - South America (Latin Americal) | Remote - Middle East | Switzerland |Bucharest :
Bucharest |Makkah :
King Abdullah Economic City | Rabigh | Najran | Jeddah | Khulais | Riyadh |Nišava District :
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Brazil | Sao paulo |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
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Taipei |Williamson :
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Ho Chi Minh City |