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Regional Clinical Study Management Director

1 month ago


Emeryville, California, United States BeiGene Full time
Job Summary

As an Associate Director, Regional Clinical Study Management at BeiGene, you will be responsible for providing leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio. You will collaborate 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.

Key Responsibilities

Regional Leadership

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

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

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.

Supervisory 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.

Requirements

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 masters degree in a scientific or healthcare discipline and 6+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.