We are seeking an Associate Director General for a 2-year-regular position (renewable) to work within the Clinical, Assessment, Regulatory, Evaluation Unit at the International Vaccine Institute in Seoul, Korea. (Duty station: Seoul, Korea)
Job Description:
This job is responsible for delivering clinical trials with high quality standards, overseeing regulatory activities, developing new programs/ projects opportunities and developing department staffs to ensure successful mission achievement of IVI on vaccines development. Itโs accompanied with high level support of the DDG CARE for managing the CARE Unit as well as ensuring extensive collaboration and consistent communication with internal and external partners under of the highest scientific, operational, and ethical standards.
Key Roles & Responsibilities:
1. Manage the overall clinical studies and related activities in CARE Unit in line with the strategic plan
- Lead the development of a clinical vaccine development agenda including (but not limited to) communication and publication plan by vaccine that will be the basis for current and future funding efforts
- Oversee clinical studies run by departments and by programs to ensure that their milestones and objectives are accomplished in a timely and successful manner (cost-effective, ethical standards, and high-quality standards)
- Provide regulatory support related to clinical activities
i. Lead or support regulatory activities for the assigned products portfolio
ii. Lead or support regulatory submissions for: New Drug/Biological Applications protocols, medical reports, efficacy and safety summaries for clinical trials as per international standards, SmPC, Package inserts, Patient information leaflet and Technical reports including submission to NRA and WHO for Prequalification
2. Develop agenda for new and current funding
- Secure program funding and diversity of IVIโs portfolio through new funding opportunities with internal/external collaborators, in line with IVI and CARE Unit strategy, as well as provide support and advice on proposals and projects including those driven by other functional areas within IVI
- Take responsibilities for compelling and insightful grant proposal which fulfill donorโs needs and IVIโs objectives to ensure sustainable funding of the clinical team and beyond
3. Act as deputy to DDG CARE, if required
- Support DDG CARE as a deputy with day-to-day management of the CARE Unit incl. cross-departmental grant development and project execution, management of FTE plan, representation of CARE at internal meetings, conflict resolution, if required
- Contribute in communicating with the board and scientific advisory group regarding scientific issues as directed by the DDG CARE.
- Act as External Representative of IVI and DDG CARE as needed (e.g., Government, donors, policy makers, collaborators)
4. Support CARE Unit management
- Build and develop sustainable talent pipeline and development including attracting and retaining especially highly talented personnel.
- Contribute to development and/or management of research scientists for complex grants or projects to ensure good coordination and execution of the grants/projects
- Manage, motivate and evaluate individual performance of unit staffs for their goal achievement
- Ensure sufficient grant funding is raised to ensure functionality of clinical team and beyond.
- Ensure adequate communication of clinical studies incl. peer-reviewed articles, donor reports, presentations at meetings/conferences.
Job Requirements and Qualifications:
1. Education Requirements
- MD
2. Related Field Work Experience
- 15+ years (7+ years of people management experience)
3. Technical and Professional Skills / Knowledge
- Ability to manage complex studies and projects with multiple international partners.
- Strong knowledge of clinical development and trial implementation preferably with vaccines and in a developing country setting
- Basic knowledge of epidemiology, statistics, on-site developing countries expertise, cultural sensitivity, communication and presentation skills.
- Knowledge of regulatory environment (national and WHO standards).
- Excellent people and management skills.
- Excellent medical writing and grant application writing skills.
- Track record of success in generating funds from public or private sector donors, highly preferred.
4. Language Proficiency
- Fluency in English