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Clinical Development Lead

5-10 years
Not Disclosed
10 April 3, 2025
Job Description
Job Type: Full Time Education: MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 


Clinical Development Lead – Biogen

Employer: Biogen
Location: Shanghai, China
Region: APAC
Department: Research & Development
Job Type: Full-time


Job Description

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.

Key Responsibilities

Strategic & Clinical Oversight

  • 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.

Study Execution & Data Integrity

  • 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.

Regulatory & Scientific Contribution

  • 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.


Qualifications

Education & Experience

  • Master’s degree required.

  • 5-10 years of clinical drug development experience, particularly in CNS or immunology diseases.

Skills & Competencies

  • 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.


Why Biogen?

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.


Data Privacy Notice for Mainland China Applicants

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.


Apply Now

Join Biogen and make a difference in clinical development. Apply today!