CMO, Sr. VP, Clinical Development - Guangzhou China or San Francisco Bay Area, China | Biospace
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CMO, Sr. VP, Clinical Development

Bio-Thera Solutions, Ltd.

Location:
Guangzhou China or San Francisco Bay Area, China
Posted Date:
9/16/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:
Allergy & Immunology, Cancer, Clinical Research, Oncology, Regulatory Affairs, Scientist Oncology,

Job Description

This senior level CMO, Sr. VP, Clinical Development, supports Bio-Thera decision-making and product R&D by leading the company’s global clinical development. We are seeking an experienced, motivated individual to serve as the Chief Medical Officer in the therapeutic areas of autoimmune diseases and cancers. The position can be based in US, preferably in the San Francisco bay area and report to the CEO remotely. She/he will take full responsibility for the company’s clinical strategy, development and operations plan. The Chief Medical Officer will join the company’s senior leadership group.

Major Responsibilities:

•   Direct and oversee the design and implementation of all stage clinical projects.
•   Ensure that all clinical programs have sound scientific and medical basis.
•   Prepare and direct overall clinical development plans; Design scientifically rigorous clinical development programs for the various indications.
•   Monitor study progress, leading the analyses and data evaluation process for progress reporting and presentations to internal senior management team and external advisory and other relative groups.
•   Prepare briefing and regulatory documents for Regulatory agencies, such as Dossiers, NDAs, INDs, Safety and Annual reports, and communicate with and responses to regulatory agencies about medical and other related issues

Requirements

•   MD or medical scientist with sub-specialty training in oncology or rheumatology
•   Experience in clinical protocol design and implementation;
•   Eight or more years of biotech or pharmaceutical industry related experience is required. Must demonstrate knowledge of clinical trial management, data management, and drug development process, and leadership skills in various settings of clinical and regulatory processes.  
•   Excellent oral and written communication skills, as well as interpersonal skills.
•   Hard working, driven to achieve creative and sound results.
•   Previous experience with leadership, collaboration, teamwork, and proven track record of success in design and implementation of phase II-III trials, oncology, autoimmune or related areas is a plus.
•   Experience in working effectively in multicultural environments is a plus.  The company is headquartered in Guangzhou, China, and the position is full-time and can be based primarily in Guangzhou, or US.  International travel is required. Bio-Thera provides competitive compensation package including company stock.

About BIO-THERA:
Bio-Thera Solutions Ltd ( www.bio-thera.com ), an emerging biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancers, autoimmune, cardiovascular diseases, and other life threatening conditions. The Company's initial internal products were focused on validated targets and disease areas with proven market opportunities. Our most advanced program, a beta3 integrin inhibitor for cardiovascular indications with potential becoming best-in-class, has competed Ph 3 patient enrollment, and NDA will be submitted to CFDA year 2017. The company product pipeline in clinical stage includes biosimilars and innovative antibodies, with two of the biosimilars in clinical for global development (Avastin Biosimilar and Humira Biosimilar).  Three other programs are in early clinical stages, they are: BAT8001 (anti-Her2 ADC for cancers), BAT1806 ( anti-IL-6R antibody for autoimmune diseases), and BAT1306 (anti-PD-1 monoclonal antibody) for cancer treatment.  The company has multiple candidates in research and IND-enabling preclinical stages, with focusing on innovative targets in the immune checkpoint and autoimmune diseases.  A new cGMP facility in compliance with ICH-cGMP (EMA and FDA regulations) has been built for the production of commercial therapeutic antibodies in Guangzhou.  The company has a R&D team of over 300 scientists and engineers, including many trained in the US.  The Company is also looking for senior level scientists, engineers, and executives in the areas of biomanufacturing sciences, process development, quality assurance and management, and clinical science. The company is also sincere and zealous in search and commitment to partnerships.  Please contact bd@bio-thera.com if there is interest in exploring potential R&D or commercial collaboration.To learn more about Bio-Thera, please visit www.bio-thera.com.  Bio-Thera is an equal opportunity employer.