We are seeking a Senior Research Scientist for a 2-year-regular position (renewable) to work within the Science Unit at the International Vaccine Institute in Seoul, Korea. (Duty station: Seoul, Korea)
Job Description
This job is responsible for ensuring the implementation of pre-clinical, clinical research and regulatory activities, while improving capacity building with external collaborators. It also requires effective management of sub-department.
Key Roles & Responsibilities
1. Develop and manage research projects in Science unit
Develop project plan and timeline. Devise or assist in drawing up new research proposals and apply for funding and grants. Propose, establish, and lead collaborative projects within Science unit and with other departments.
2. Provide regulatory support related to pre-clinical and clinical activities
Lead or support regulatory activities Expert Guidance: Provide expert input on Korean regulatory requirements and processes to enhance the organizationโs understanding of the regulatory landscape in South Korea. Regulatory Pathway Development: Collaborate with the Science unit and Clinical Development team to advise on regulatory pathways for new vaccine developments, ensuring alignment with both local and international regulatory requirements. Liaise with KFMDS to support vaccine-related discussions incl. obtaining export-only licenses Support current and upcoming activities related to technology transfer to Korean manufacturers
3. Cross-Unit Collaboration
Work closely with the Regulatory team in CARE, EPIC and I2N3 to share insights and strategies, facilitating a cohesive approach to regulatory submissions and compliance across different regions. Support GTH-B training program
4. Interact with key stakeholders
Communicate results to the scientific community through publication, presentation, etc.
5. Contribute to strategic and operational decisions
Attend and participate actively to the regular PMC & Senior management meetings. Attend and participate to meetings and events organized by IVI.
6. Capacity strengthening
The Regulatory Science expert collaborates with the Training Program Operations Manager and the Training Development Manager to enhance and expand future training programs in the regulatory field, actively contributes to the development of new initiatives as needed, engages with internal and external stakeholders, and delivers essential presentations
7. Assist in the Head of the Science Unit in ensuring timely and effective execution of Science Unit projects.
Review project plans and timelines and track overall consolidated work plan Prepare qualified Science Unitโs documents and procedure Identify opportunities for collaboration between Science Unit and other IVI departments Support implementation of lab quality policies & standards Propose, establish and lead collaborative projects within Science Unit and with other departments
Job Requirements and Qualifications
1. Education Requirements
M.D., Ph. D. or equivalent
2. Related Field Work Experience
10+ years in Korea Ministry of Food and Drug Safety
3. Technical and Professional Skills / Knowledge
Knowledge of regulatory requirements and processes related to drugs and vaccines