JOB FUNCTION: Clinical Research
GRADE/TITLE: Senior Manager to Assistant Director
EMPLOYER: Brii Biosciences （腾盛博药）
DEPARTMENT: Clinical Development
REPORTS TO: Executive Director of Clinical Research
EFFECTIVE DATE: 6/15/2019
SUMMARY: This position will provide an ideal career entry point to clinical development in biotechnology and pharmaceutical industry. This role is an integral part of development team and therefore enables the chosen candidate to quickly gain experience in various aspects of a project physician. Numerous on-job training and learning opportunities further accelerate development of key skills and capabilities to become an independent contributor.
DUTIES AND RESPONSIBILITIES:
Works collaboratively with the Clinical Project Team on all scientific and medical aspects of designing and planning trials.
Works closely with the Regulatory Affairs, Project Management, Clinical Trial Operations, and Early Commercial team members for the planning and execution of clinical studies.
Compiles required documents of clinical data and plan in supporting China registration.
Participates 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 seeks feedback for clinical development plan and protocols as needed.
Works with Clinical Operations team in planning and execution of site assessment, selection, initiation, oversight, and training of investigators and staff.
Performs clinical monitor functions for assigned 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 medical 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 identifies 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 internal medicine is highly valued.
The qualified candidate is highly interested in clinical development of innovative medicines.
0-3 years of relevant experience in clinical development or relevant work.
Excellent language skills in both English and Chinese (fluent in verbal and written).
Excellent interpersonal skills are required. Must have a proven ability to work highly effectively with cross functional collaborators.
Capable of building 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.
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.