Director, Clinical Operations

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.  

Director, Clinical Operations

As the Director, Clinical Operations you will be a key member of the Oncology Operations Team. You will be responsible for operational delivery of the studies and/or programs across the Asia Pacific team. You will contribute towards development of the methodology for conduct of the clinical trials, improving current methodology, and being accountable assigned to him/her.

Position Responsibilities/Accountabilities:

• Accountable for the activities of the Asia Pacific team members.
• May perform some or all PM responsibilities on key projects or as needed to support direct reports and/or clients.
• Support project activities leading to building client relationships for defines customers and/or contracts; deliver “The Catalyst impact.” 
• Provide input into development of the planning and reporting framework based on and utilizing the core systems, internal KPIs and in line with external customer expectations.
• Review KPIs tracked per project to monitor overall project delivery and client satisfaction and to take a proactive approach in management engagement and awareness of the project status.
• Develop SOPs to govern the Asia Pacific function.
• Identify the need and support development of the Project specific SOPs.
• Accountable for the financial management of the projects.
• Responsible for the financial management of the Asia Pacific function.
• Provide input into development of the departmental budget.
• Take part in the development and implementation of the revenue recognition, project profitability, contract scope management and invoicing methodologies.
• Represent Asia Pacific function during QA audits.
• Accountable for overall project and Asia Pacific team members readiness for the QA audits.
• Complete CAPA in response to internally identified system/process weaknesses and/or customer complaints related to Clinical Operations.  
• Support to Business Development representatives for the “solutioneering” of appropriate solutions for customers individual needs and the closing and contracting of new business
• Drive operational elements of proposals and Bid Defense materials in collaboration with other team members.
• Other responsibilities and ad hoc projects as required.

Managerial Requirements/ Responsibilities:

Position will have management responsibilities. Development, oversight, and direction of country and departmental staff which will include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting & salary.

Position Qualification Requirements:

Education: University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology. Master’s Degree in scientific or business discipline preferred. 

Experience: 10+ years in a clinical research setting with a progression of increased responsibility over time. 2+ years of management experience in a CRO setting with in depth knowledge of the project management activities. Previous exposure to and experience of Oncology specific clinical development complexities.

Required Certifications:  N/A

Required Skills:

• Strong knowledge of the drug development process and MFDS regulations, ICH GCP guidelines, and their application to clinical trials.
• Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes.
• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Excellent presentation skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills.
• Ability to deal effectively with a diversity of individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to work independently and as a member of various teams and committees.
• Good judgement with the ability to make timely and sound decisions.
• Ability and willingness to travel to investigator meetings, investigate sites and bid defense meetings, etc., up to 10%.

Applicants must be authorized to work for ANY employer in South Korea. We are unable to sponsor or take over sponsorship of an employment visa.