Senior Clinical Research Clinician

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – MD Job Category: Scientific/Technology All Job Posting Locations: Beijing, China, Shanghai, China Job Description: Senior Clinical Research Clinician Job information: Position: Senior Clinical Research Clinician Department: Clinical Development (CD) Report to (Job Title): Senior Clinical Research Lead Direct Report (Number): Peer Position: Other Functional Managers General job accountability: Lead the clinical trials for the assigned compounds or products in China and/or globally (for some specific China R&D-driven compounds). Accountable for all clinical trials deliverables according to Clinical Development plan. Principal accountability and internal and external contacts: (Please attach other paper if needed) A. Primary responsibility Lead the clinical trials for the assigned compounds or products in China. Propose clinical study design and develop clinical study protocol based on the clinical development plan. Be accountable for clinical trial deliverables (e.g., Clinical study protocol, clinical study reports, and submission summary / HA response document). Ensure the medical and scientific sound and fully meet HA requirements for the compound registration. Provide clinical inputs and resolution for medical issues. Act as a clinical expert concerning clinical scientific issues of internal and external customers. B. Contacts of key internal and external stakeholders Internal External Cross- function teams in China R&D (e.g. RA, GCO, Statistics, Discovery, MAF, DM, Programmer etc.) Investigators/KOLs Global clinical team Specialized medical association and other key stake holders China Clinical leader and other relevant clinical persons Qualification and competency requirements： undefined Education /Training background: undefined Knowledge/Skills: Thoroughly understand and command knowledge of product and relevant diseases Solid knowledge of clinical development process and HA (especially CFDA) requirements Thoroughly understand and command GCP Thoroughly understand and command HCC Job experience: undefined undefined Competency: undefined Others: undefined Required Skills: Preferred Skills: Clinical Research and Regulations, Clinical Trials, Clinical Trials Operations, Collaboration, Consulting, Data Management and Informatics, Drug Discovery Development, Industry Analysis, Innovation, Leadership, Market Research, Regulatory Affairs Management, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management, Tactical Planning, Technical Credibility