JOB FUNCTION: Clinical Development
GRADE/TITLE: Level 9-10/Director or Senior Director
EMPLOYER: Brii Biosciences (腾盛博药)
DEPARTMENT: China Clinical Development
JOB LOCATION: Beijing(preferred) or Shanghai, China
REPORTS TO: Office of CMO
EFFECTIVE DATE: 3/1/2019 or earlier
SUMMARY: Develops and directs medicine development team in China; builds clinical trial network and advisory capabilities; coordinates all functional supports with budgetary responsibility.
DUTIES AND RESPONSIBILITIES:
Leads project development team and executes on medicine vision in China.
Serves as the medical Lead for clinical trials execution with cross-functional multidisciplinary study teams:
Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions
Serves on cross-functional Study Teams for assigned trials, working with other team members to achieve efficient, high-quality study execution
Provide scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)
Serves as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects.
Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
Represents Brii Biosciences for the external engagement of medical community, consortium, advisory board.
Oversees early implementation of digital data capabilities to optimize clinical development and patient experience.
Works closely with medical affairs and marketing teams to develop deep understanding of patient’s need, physician insight, product differentiation and access strategy.
MD with clinical training in infectious diseases, CNS diseases, internal medicines or another relevant medical field, is highly desired; clinical experience in acute and chronic care in both in-patient and out-patient settings will be a plus.
At least 5 years of clinical care with deep understanding of China’s healthcare systems, physician practices, patient flow, payment systems, medical records and claim processes.
At least 5 years of basic or clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design.
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
Global clinical research experience and experience interacting with regulatory authorities is a plus.
Excellent oral and written communication skills in Chinese and English.
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.