Description
We are seeking an outstanding and highly motivated candidate as Senior Director or Director level with extensive expertise to lead clinical programs of cell therapy (e.g. CAR-T, CAR-NK) and oncolytic virus in Global Biologics Research Department at WuXi Biologics in Shanghai. The candidate will be responsible for clinical development of cell therapy or oncolytic virus. The position will require strong expertise in clinical study design and execution, superior management capabilities and excellent communication skills. The candidate will provide scientific leadership and expertise to the development of first-in-class/best-in-class cell therapy and oncolytic virus drug candidates.
Key Responsibilities
· Provide scientific and medical leadership to support CAR-T, CAR-NK and oncolytic virus clinical development in various stages; provide strategic medical insight and operational input into core medical activities.
· Provide medical monitoring for clinical trials, including but not limited to clinical plans design, eligibility criteria assessment, toxicity management, drug safety surveillance and data interpretation.
· Function as the medical and clinical lead for new drug development activities, including evaluation of new product potential and strategic recommendation with medical expertise.
· Contribute to the preparation of IND medical sections.
· Work closely with internal team and CRO in clinical trial execution, and provide guidance to CRO for protocol-specific clinical issues, site problems, and recruitment strategies.
Qualifications
· MD, Ph.D or MS in clinical medicine, basic medical sciences, pathology, cell biology, immunology, biochemical engineering or related fields with at least 6 years of clinical drug development experience in pharmaceutical company.
· Solid experience in clinical trial design, initiation and management is required; Knowledge in pathology, cell biology and immunology is required.
· Be familiar with the domestic and global regulation for clinical trials.
· Prior cell therapy/Oncolytic virus experience of clinical trials is preferred.
· Experience in IND application of cellular and gene therapy is preferred.
· Excellent interpersonal, oral, and written communication skills.