The Asia Pac Clinical Trial and Engagement Manager will lead efforts within the Asia Pacific area (focusing on the Republic of Korea and Japan) to drive clinical studies in the region, liaise with local CROs, site staff, and study investigators, and engage investigators at medical institutions in the countries to maintain good relationships and foster engagement.

This role will be accountable for the successful execution at clinical sites in the Asia-Pacific region (particularly in the Republic of Korea and Japan) involved in company-sponsored clinical studies. This includes studies managed with in-house resources or outsourced to CROs. This also includes global studies in which Korea, Japan, and/or other countries within the Asia-Pacific region are participating countries. This role is responsible and accountable for the achievement of project/corporate goals and objectives on time and budget.

This role is also focused on strengthening the relationship between the study teams and clinical study sites, driving start-up activities, and leading and driving the site engagement strategies.

Clinical programs include those in both Neurology and Oncology.

Essential Functions

• Provide leadership and ensure oversight of all company-sponsored studies run in Korea, Japan, and other Asia Pac countries

• Develop influential relationships with national and local key external experts, leading to a productive two-way exchange of scientific information and opinion

• Provide direction to the Korean/Japanese/Asia Pacific CRO and vendor selection and management

• Provide comprehensive oversight of all CRO and vendor activities in Asia Pacific, ensuring timelines and budgets are met. This needs to be done in conjunction with Global Clinical Development Operations (GCDO)

• Provide leadership and expertise in site selection for all programs run in Korea and Japan

• Ensure regional study/site start-up timelines are aggressive yet attainable

• Ensure regional patient enrollment projections are aggressive yet attainable

• Accountable for meeting all study start-up projections

• Accountable for meeting patient enrollment targets

• Coordinate and attend site engagement visits as necessary

• Provide input as required into the development of clinical documents (protocols, monitoring plans, clinical trial reports, investigator brochures, etc.).

• Accountable for providing and meeting local study budgets as required

Required Knowledge, Skills, and Abilities

• Leads without direction, demonstrates the ability to work independently and in a team environment

• Required ability to influence without authority or gain acceptance/consensus from others in sensitive situations without damage to the relationship

• Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations in Korea and Japan

• Deep knowledge and comprehensive understanding of ICH/GCP requirements, Korean requirements, and Japan-GCP (J-GCP)

• CRA monitoring-related experience or clinical study management experience within pharma/CRO and/or biotech industries

• Must have experience with leading the management of third-party vendors, managing CROs, central laboratories, and other clinical study vendors in Japan (and/or Korea)

• Must have a working knowledge of data management, data review and analysis, and drug safety and pharmacovigilance

• International experience is highly preferred

• Effective leadership skills and proven ability to foster team productivity and cohesiveness

• Excellent oral and written communication skills and strong organizational and prioritization abilities

• Travel required (including significant travel to the Republic of Korea)

Required/Preferred Education and Licenses

• Bachelor’s degree, nursing degree, or health-related degree required (Degree in the life sciences preferred)

• Minimum of 7 years of related experience in the pharmaceutical or biotechnology industry

• Significant and recent experience in Oncology clinical development is highly preferred

• Fluent in (speaking, reading & writing) Korean, business proficiency in Japanese and English (fluency in both spoken and written Japanese & English is preferred, but high proficiency in written Japanese and English with some proficiency in spoken Japanese & English is acceptable)