Full-time

BeOne is hiring a Director, Regional Clinical Study Management

About the Role

Xsolla is seeking a Director, Regional Clinical Study Management to provide strategic leadership and management for a team of Associate Directors, Operations Managers, and Operations Associates. In this role, you will drive the Clinical Operations strategy for the region, ensuring trials are delivered on time and with quality while managing team performance, resourcing, and capability development.

What You'll Do

  • Provide leadership, management, and mentorship to associate directors and clinical study managers for the assigned portfolio.
  • Collaborate with internal, external, regional, and global stakeholders to ensure business needs are met.
  • Drive resourcing and capability development for regional study management.
  • Ensure alignment of regional resources and deliverables with overall portfolio goals.
  • Collaborate with regional Clinical Operations leadership to ensure smooth trial delivery on time and with quality.
  • Liaise with external stakeholders such as FSP partners, clinical operations leaders in other regions, and monitoring heads.
  • Drive the overall Clinical Operations strategy for the region and be accountable for performance against key metrics.
  • Drive the development of initiatives and novel ideas for delivering clinical trials.
  • Ensure team members are trained on and adhere to required processes and SOPs.
  • Drive a quality mindset and proactive risk management in the regional study management organization.
  • Set clear quality expectations for the regional study management organization.
  • Drive knowledge management and continuous improvement processes.
  • Contribute to the resourcing process for regional study management, ensuring efficient assignment of personnel.
  • Conduct performance appraisals and provide feedback for direct reports.
  • Support the setup of development plans for direct reports.
  • Drive the hiring of new talent into the regional study management organization.

What We're Looking For

  • Bachelor's degree in a scientific or healthcare discipline.
  • 10+ years of progressive experience in clinical operations within biotech, pharmaceutical, or CRO industry.
  • Solid leadership and extensive experience as a direct line manager.
  • Strong written and verbal communication skills.
  • Ability to exercise 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.

Nice to Have

  • Master's degree in a scientific or healthcare discipline.
  • 7+ years of progressive experience in clinical operations within biotech, pharmaceutical, or CRO industry.

Technical Stack

  • MS Office
  • Project Planning Applications

Team & Environment

You will lead a team of Associate Directors, Operations Managers, and Operations Associates and be part of the Regional Clinical Operations leadership team.

Benefits & Compensation

  • Compensation range: $168,600.00 - $228,600.00 annually.
  • Eligibility for discretionary equity awards.
  • Eligibility to participate in Employee Stock Purchase Plan.
  • Medical, Dental, Vision insurance.
  • 401(k).
  • FSA/HSA.
  • Life Insurance.
  • Paid Time Off.
  • Wellness programs.

Xsolla is an equal opportunity employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.

Required Skills
MS OfficeProject Planning ApplicationsClinical Study ManagementClinical OperationsTeam LeadershipVendor ManagementBudget ManagementCross-functional CollaborationRegulatory ComplianceProcess ImprovementStakeholder CommunicationStrategic PlanningResource ManagementRisk Management
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Job Details
Category management
Posted 3 months ago