About us

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description:

General Description:

• Accountable for the study start-up timelines and delivery, with high quality and according to ICH/GCP
• Improvement of Study/ Site Start Up timeline in Japan.

Description for focusing on Japan:

• Supports Senior Director to build Japan organization and required process such as Local SOP and WI.
• Conducts Country level feasibility in collaboration with rCSM.
• Supports country activity for new studies until reginal/ country CSM is identified.
• Oversees and support Study/ Site Start Up tasks to ensure to meet study milestones.
• Prepares and supports PMDA inspection.
• Other tasks, if needed.

Essential Functions of the job:

• Independently oversee clinical start-up component of all studies in Japan with accountability for time, cost and quality for assigned activities, which include, but not limited to,
  • Investigator/Site identification, including conduct feasibility activity to identify investigators.
  • Prepare, review, submit and QC submissions to Institution Review Board (IRB) to obtain clinical trial authorizations and approvals.
  • Prepare and review, site level critical documents for IP release.
  • Develop and finalize Country and Site-Specific ICFs.
  • Perform site contract/ budget negotiation during start-up and maintenance phase. (if required)
  • Review and finalize subject compensation rule and insurance as per local regulations.
  • Review and translate subject recruitment materials as per local regulations if required.
  • Prepare, submit regulatory documents to RA and obtain approval for required study.
  • Assist CSMs in managing clinical trial during startup phase.
• Work closely with Clinical Operation leads to plan start-up resource.
• Assist in company Start-up SOPs development
• Assist in maintain and update company-level investigator database.
• Establish, maintain and enhance relationship with key opinion investigators and sites.
• Proactively identify potential issues and seek improvement. Take initiative for issue resolution within and outside start-up team. Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans.
• Performs QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for BeiGene studies.
• Perform other duties as assigned by management.

Supervisory Responsibilities:

• No direct reporting staffs but be a mentor for new staffs if required.

Qualification Required:

Education Required:

• Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
• 8 or more years of clinical research experience in the Pharmaceutical or CRO industry

Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Other Qualifications:

• Knowledgeable expert in the execution of clinical trials, expert understanding of GCP/ICH Guidelines and other applicable regulatory requirements
• Recent start-up experience in Japan
• Demonstrated experience working on a team across multiple functional areas and studies.
• Excellent communication, relationship building and interpersonal skills
• Excellent organizational skills and ability to prioritize multiple tasks
• Self-motivation with the ability to work under pressure to meet deadlines
• Fluent in English (writing and speaking)

Travel: potential travel of up to 10%

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant and performance-based annual equity plan!)
• In-house and external learning and development opportunities
• Fantastic benefits program and keep improving!
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
• Join us and Make momentum in your career!

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeiGene’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (https://www.beigene.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.