Summary of Position
Viela Bio is looking for a talented and highly motivated Clinician to join our team. This position will have full responsibility for the planning, implementation and daily operation of drug development projects. He or she will collaborate with key internal and external stakeholders to support company initiatives that improve the quality and content of all clinical programs to deliver our portfolio.
- Will be responsible for delivery of development projects.
- Direct/Oversee the design and implementation of early stage clinical projects, as a member of our Product
- Development Team (PDT) and leader of the Clinical Sub-Team (CST). Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
- Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.
- Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan.
- Present and defend protocols and clinical development plans at internal governance forums.
- Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II/III studies, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documentations.
- Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.
- Present study updates, interim results, and final headline data to senior management as required.
- Provide medical input and contribute to the clinical development sections of regulatory documents such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
- Ensure that Serious Adverse Events are properly reported on a global basis.
- Direct responsibility for leading a team of Clinical Development professionals and ensure delivery of their portfolio of assets.
- Implement clinical R&D policies, SOPs and related directives.
- Review potential in-licensing candidates and present recommendations to Senior Management groups.
- Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
Desired Skills and Experiences:
- 5 plus years in clinical research and/or drug development in CRO, pharmaceutical environment, or academia.
- Good understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.
Education and Minimal Requirement
MD with a valid US medical license preferred; Medical specialty and sub-specialty training in an area related to autoimmune diseases required.