Director, Regional Clinical Study Management

BeiGene

1d•$171,900 - $231,900•Onsite

About The Position

BeOne 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. General Description: Line management responsibilities: Provides leadership, management, and/or mentorship to associate directors, 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. Drives 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 Associate Directors, 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. Drives the overall Clinical Operations strategy for the region and has accountability for performance against key metrics. Drives 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. Drives 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. Drives 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. Supervisory Responsibilities: Line management responsibilities: Conducts performance appraisals for direct reports which includes providing feedback. Supports set up of development plans for direct reports. Drives the hiring of new talent into the regional study management organization.

Requirements

Solid leadership and extensive experience either as direct line manager (required for those with line management responsibilities) 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
Bachelor's degree in a scientific or healthcare discipline and 10+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.

Nice To Haves

Preferably master’s degree in a scientific or healthcare discipline and 7+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.

Responsibilities

Provides leadership, management, and/or mentorship to associate directors, 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.
Drives resourcing and capability development related to regional study management
Ensures alignment of regional resources and deliverables with overall portfolio goals
Provides leadership to the team of Associate Directors, 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.
Drives the overall Clinical Operations strategy for the region and has accountability for performance against key metrics.
Drives the development of initiatives and ensures that novel ideas on how to deliver on clinical trials are generated and considered.
Ensures team members are trained on and are adhering to required processes and SOPs.
Drives 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.
Drives the knowledge management and continuous improvement process by ensuring information is captured, retained, and leveraged in future work.
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.
Conducts performance appraisals for direct reports which includes providing feedback.
Supports set up of development plans for direct reports.
Drives the hiring of new talent into the regional study management organization.