Associate Director, Regional Clinical Study Management
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:
Line management responsibilities:
- Provides leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio
- Collaborates effectively with internal and external stakeholders within the region as well as with global stakeholders to ensure the needs of the business are met.
- Contributes to overall Clinical Operations strategy for the region and is accountable for performance against key metrics
- Contributes to resourcing and capability development related to regional study management
- Ensures alignment of regional resources and deliverables with overall portfolio goals
Essential Functions of the job:
Regional Leadership
Line management responsibilities:
- Provides leadership to the team of Operations Managers and Operations Associates in charge of regional study management, including mentoring, coaching and managing performance
- Collaborates with peers in the regional Clinical Operations leadership team to ensure smooth delivery of all trials in the region on time, with quality and in line with the broader organizational goals
- Liaises and collaborates as required with external, global and/or regional stakeholders such as e.g., FSP partners, clinical operations leaders in other regions, and monitoring heads in key countries in the region
- Contributes to the overall Clinical Operations strategy for the region and has accountability for performance against key metrics
- Supports the development of initiatives and ensures that novel ideas on how to deliver on clinical trials are generated and considered
Quality
Line management responsibilities:
- Ensures team members are trained on and are adhering to required processes and SOPs
- Promotes a quality mindset in the regional study management organization and supports the proactive implementation of risk management principles in the regional study management organization
- Sets clear quality expectations for the regional study management organization
- Supports the knowledge management and continuous improvement process by ensuring information is captured, retained, and leveraged in future work
Budget and Resources
Line management responsibilities:
- Contributes to the resourcing process for regional study management. Ensures efficient resourcing addressing both study needs as well as individual development needs through the principle of assigning the right person to the right study at the right point in time
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.
- Supports country activity for new studies until regional/ country CSM is identified.
- Vendor management for FSP partners and dispatching staffs in Japan.
- Takes trial management responsibility if required.
- Conducts Site Motivation visits and Site Engagement Visit in Japan.
- Prepares and supports PMDA inspection
- Other tasks, if needed.
Supervisory Responsibilities:
Line management responsibilities:
- Conducts performance appraisals for direct reports which includes providing feedback
- Supports set up of development plans for direct reports
- Contributes to the hiring of new talent into the regional study management organization
Qualification Required:
Education & Experience Required:
Bachelor's degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. Preferably master’s degree in a scientific or healthcare discipline and 6+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.
Computer Skills:
- MS Office, Project Planning Applications
Other Qualifications:
- Solid leadership and management experience either as direct line manager or as cross functional team lead
- Strong written and verbal communication skills
- Exercises sound judgement and discretion in matters of significance
- Ability to work independently and effectively handle multiple priorities in a fast-paced environment
- Excellent interpersonal skills, strong organizational skills and ability to influence and lead
Travel:
Travel might be required as per business need.
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.
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