Position Summary

This position will be responsible for Immunology asset development in EVEREST, develop clinical development strategy, execute clinical trials as medical monitor, engage external HCP and regulatory HA. Mainly responsible for the following functions:

• Lead or support Immunology new asset clinical development strategy. 
• Responsible for the clinical study design/protocol development/trial monitoring/clinical study report.
• Build strong connection with external KOLs and gain insights to support clinical development.
• Representing clinical development function, build internal and external partnership.

Key Responsibilities

•  Acknowledging the guidelines, academic progress and trends of the related immunology therapeutic area, reading related reference/documents, attending academic conference.  
• Reading internal data, grasp the pipeline information.
• Effective communication with KOL, understanding Chinese clinical practice and clinical requirements.
• Discussing and drafting CDP of new pipeline.
• Closely consulting with partner company, acknowledging the development strategy of partner company.
• Understanding the details of the protocol, confirming reasonable protocol design after communicating with cross function. (Regulatory Affairs, Clinical, Data Management and Statistician, PV, commercial et al), external experts (Clinical Experts, Statisticians, Pharmaceutical Experts) and CDE reviewers.
• Working closely with project team members, draft review process and timeline of the protocol.
• Reviewing/Developing clinical study protocol.
• Composing and executing medical monitor plan with discussing among project members based on project requirement.
• Familiar with clinical study process, conducting regular medical review on clinical data cooperating with project members.
• Solving medical questions of the protocol (e.g. medicine background, inclusion/exclusion criteria, combination medication, dosage adjustment of the study drug and discontinuation criteria et al.).
• Working closely with project team members, discussing and reviewing clinical study related documents. 
• Familiar with the requirement of the clinical CSR, Scientific analyzing and discussing for the clinical data, reviewing/composing clinical CSR.
• Giving medical support and comments to the disclosure and publication of the clinical study data.
• Giving medical support with discussion among project members for the submitting and approval of the IND and NDA.
• Working closely with Regulatory Affairs, answering medical questions from CDE reviewers, and preparing medical documents and solving medical issues for the CDE consult meeting.
• Based on the work arrangement.  

Recommended Education and Key Competency

Basic Qualifications 

• Master’s degree in medicine or above. 
• Minimum 10 years of experience in immunology.
• Preferred Qualifications.
• Significant training/experience of Medical Monitor in clinical development in industry.
• Early clinical development experience.
• Experience in immunology studies.

Knowledge

• Extensive knowledge of ICH/GCP regulations and guidelines. 
• Compliance and Pharmacovigilance.
• Pharmaceutical industry environment.
• Clinical development process.

Key Competencies

• Strong communication skills and influence skills.
• Ability to work within team.
• Scientific/Technical excellence. 
• Critical thinking and Problem solving. 
• Can-do attitude and willingness to take on challenging tasks.
• Language: Chinese & Business English fluency. 
• Ability to work effectively in a changing environment.