JOB SUMMARY:
Position is responsible for deliver quality of the product, including protocol, medical monitor planning ,training material, IB,ICF and investigator relations. Support head to manage partner function including Data manager, statistical analysis and PV. Conduct medical and SAE review.
KEY DUTIES AND RESPONSIBILITIES:
• Serve as a key member of product team to contribute to the accomplishment of trial objectives outlined by the clinical development plan;
• Govern the development of key medical and clinical documents, especially for China, including but not limited to IB, clinical study protocol, informed consent form, CSR, etc. (work could be done internally or out-sourced);
• At program level, provide medical insight to product development, support IND/NDA related work, and coordinate related discussion between vendors and pre-clinical/CMC team in China, e.g., guideline interpretation (Endocrine and Metabolic or oncology-related background preferred);
• At study level, provide medical support for study sites based in China , also conduct medical data review of subject eligibility, safety cases, protocols deviation log, etc.;
• As medical lead for local sponsored trials, covering from study design to final result analysis;
• Interface with the medical function from vendors;
• Participating in investigator meetings and various trial advisory committees (e.g. Steering Committee), while being accountable for driving some medical content for the meetings.
QUALIFICATIONS (KNOWLEDGE, EXPERIENCE, ABILITIES & SKILLS)
• At least Master’s degree in medical, biological, or life sciences, PhD / MD preferred;
• At least 5 years’ experience in the biopharmaceutical industry, with experience of clinical trial related activities is preferred;
• Understanding the process of drug development, with experience in biotech background preferred;
• Knowledge and familiarity with industry standards including ICH guidelines, GCP and regulations;
• Performance driven with ability to work independently, with proven operational and tracking skills;
• Excellent organizational and priority management skills;
• Exceptional interpersonal and communication skills with conflict resolution and consensus building abilities;
• Highly collaborative and works well in a team environment, especially able to work effectively with colleagues from different function. proven operational and tracking skills;
• Excellent organizational and priority management skills;
• Exceptional interpersonal and communication skills with conflict resolution and consensus building abilities;
• Highly collaborative and works well in a team environment, especially able to work effectively with colleagues from different function.