JOB FUNCTION: Clinical Research
GRADE/TITLE: Level 8/Associate Director
EMPLOYER: Brii Biosciences （腾盛博药）
DEPARTMENT: Clinical Development
REPORTS TO: Executive Director of Clinical Research
EFFECTIVE DATE: 3/1/2019
SUMMARY: This individual will play a key role as a project physician at all stages of clinical development, focusing initially on infectious disease.
DUTIES AND RESPONSIBILITIES:
Works collaboratively with the clinical project team on all scientific aspects of designing and planning trials.
Works closely with the regulatory affair, project management, clinical trial operations, and commercial teams for the planning and execution of China registration studies.
Compiles required documents of clinical data and plan in supporting China registration.
Leads clinical study design and collaborates with biostatisticians, regulatory affairs, and other relevant disciplines to construct high-quality clinical study protocols.
Engages and introduces new compounds in development to external scientific leaders (KOLs), and seek feedback for clinical development plan and protocols as needed.
Works with clinical operation team in planning and execution of site assessment, selection and training of investogators and staff.
Performs clinical monitor for studies and works with study team to ensure safety/efficacy/quality, data accurately captured and serious adverse events reviewed.
Serves as the contact for site study team to address protocol related questions and emerging safety issues.
Provides inputs and approves monitoring plan/reports/data listings.
Interprets, prepares clinical study reports, regulatory dossier, regulatory responses, and review product label related to assigned compounds.
Participates in preparation and review manuscript for publication.
Participates due diligence evaluation and identifys gap/opportunities of health care in China and contributes to conceptualizing plan/study to address the emerging opportunities.
Performs other related duties as assigned by management.
Medical Degree (MD) or equivalent, and clinical training in infectious diseases or internal medicine is highly valued.
5+ years of relevant experience in the industry and preferably with ID specialization or relevant work. The qualified candidate will possess the knowledge, experience, and skills with a proven track record of accomplishment in the field of clinical development. IND filing experience will be highly desirable.
Excellent language skills in both English and Chinese (fluent in verbal and written). Previous experience of protocol and study report writing is highly desirable.
Excellent interpersonal skills are required. Must have a proven ability to work highly effectively with multiple departments.
Thorough understanding of cross-functional processes involved in study design and execution, including protocol development, data management, safety/ pharmacovigilance, biostatistics, medical writing, quality assurance, regulatory- and medical- affairs.
Experience and capability to maintain a professional relationship with therapeutic area opinion leaders to discuss the science and research approaches that are critical for study protocol design and data interpretation.
Advanced working knowledge of good clinical practices and International Conference on Harmonization Guidelines is required.
Capable of working with attention to details in a time sensitive environment.
Flexibility to work in a rapidly growing matrixed environment and work outside of the area of primary medical specialization.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.