Position Summary:

The Director of Clinical Operations (CO) APAC Region will be based in the OBI Taipei office and is a key leader in strategic planning, operational oversight and management of OBI's clinical trial portfolio. The CO APAC Director will work across and collaborate with multiple functions to ensure operational trial deliverables are completed in accordance with established timelines, budget, operational procedures, quality standards and in compliance with applicable ICH/GCP regulations. The CO APAC Director will possess exceptional people management skills and will be expected to engage, manage, develop and motivate a regional team of operational professionals. As part of the CO Leadership Team, they will partner closely with the VP of Clinical Operations and other regional CO Leads to help shape the strategic direction and overall management of the global CO function.

Responsibility:

1. Responsible for the management of the Taipei based OBI CO team. Direct line reports will include Sr./CTMs, Clinical Assistants and possibly others, as assigned.

2.Be the role model and set clear expectations for team interaction, collaboration and culture. Model how to respectfully disagree with your team and encourage them to tactfully express their opinions. Help your team learn to correct their own mistakes by helping them understand the problem and act as their sounding board for troubleshooting fixes. Build strong relationships with your team and show you value their input and suggestions.

3. Develop plans and progress checks to ensure that Taipei based CO staff maintain qualifications for their positions, are being developed to assume more responsibility and are trained appropriately on all applicable regulations, as well as OBI Pharma standards, through mentoring, formal instruction, and/or in house training. Foster a high level of employee engagement and job satisfaction.

4. Function as an integral member of the CO Leadership team and partner closely with US and Europe/LatAm regional Leads. Actively engage in hiring activities, goal setting, performance management, promotion and merit decisions for Taipei--based employees and outside consultants.

5. Contribute to the development of priority project goals and landmarks annually. Ensure team goals align with Company objectives and are impactful and meaningful. Hold progress updates with your staff and summarize status to upper management or the department head on a regular basis.

6. Be viewed as an operational and strategic authority by the company and in the field. Be amenable to regular interactions with executives and major customers.

7. Be responsible for shaping and implementing standard methodologies for the conduct of clinical studies. Partner with QA to ensure SOPs and Work Instructions are harmonized across the US and Taiwan offices.

8. Ensure clinical studies can withstand audit scrutiny by any Regulatory entity where the risk of failure can affect the business or the product/solution.

9. Ensure all applicable international and/or local statutes governing human participation in clinical testing and research studies are followed.

10. Ensure all clinical studies are aligned with the Clinical and Regulatory strategy described in project plans.

11. Responsible for leading one or more business processes, including overall control of planning, staffing, budgeting, determining expense priorities, and recommending and implementing changes to methods.

12. Partner with Clinical Outsourcing and Vendor Management to identify, select, contract and grade performance of the vendors that support the CO function.

13. May be required to represent the study operations team and/or department during meetings with KOLs, management, FDA, and other global regulatory authorities, business or functional groups.

14. Occasional domestic and international travel to clinical sites and congresses.