Clinical Research Physician

Job Title Clinical Research Physician
Report To:
Sensitivity:Sensitive, NDA is a must

1. Clinical Research
▲Identify and develop research strategies for products
Develop appropriate protocol synopsis and protocols to support research proposals and meet local registration needs
Actively participate feasibilities at program, protocol and site level for global/regional studies, and provide timely and quality feedback
Translate final protocols and amendments for global/regional studies
Assist with Study Manager (Operational Lead) in Coordinating Principal Investigator and leading site selection
Develop local ICDs (Informed Consent Document), and translate as needed
Prepare and deliver presentations for product and protocol introduction at Investigators Meeting and answer related questions from investigators
Review and provide comments on study documents as required
Act as Protocol Lead and Clinical Lead in a study team, approve protocol deviations, analyze AEs/SAEs, and answer clinical and product queries from investigators
Provide valuable inputs in SAP (Statistical Analysis Plan) finalization and efforts in achieving Database clean
Prepare and finalize local clinical study report, and assist NDA submission
Maintain high level of clinical understanding to products
Provide disease and protocol training to monitors as needed
Establish and maintain an effective network of relationships with key opinion leaders

2. New product registration
Translate and prepare clinical section of IND submission dossier (e.g. IB, study reports from previous clinical trials, clinical summary)
Prepare clinical related response to SFDA/CDE for any queries as required
Prepare slides and deliver presentations of clinical section to CDE Review Meeting as required

1. Educational / Training
University Degree and Medical qualification
Advanced Degree in biomedical sciences (MSc, PhD) preferred

2. Working Experiences
At least 3 years clinical experience1
At least 2 years international pharmaceutical industry experience
Experiences in assigned therapeutic areas is preferred
Knowledge of Chinese/ICH GCP guidelines
Knowledge on drug development process
Knowledge of clinical trial methodology
Knowledge of country regulatory environment
Proficiency in Basic Microsoft Word, Outlook, PowerPoint and Excel

3. Functional Ability
Competitive capability of strategic and analytical thinking, planning and organization
Strong professional expertise
Be proactive and initiative
Decision making and a problem solver
Relationship management, teamwork, influence and leadership
Attention to details
Excellent communication skills
Excellent presentation skills
Fluency in English (oral and writing) is a must

4. Cultural Competencies (Leader Behaviors)
Sustain Focus on Performance
Manage Change
Create an Inclusive Environment
Encourage Open Discussion and Debate
Align Across company
Develop People