VP/SVP/CMO, Clinical Development
VP/Sr. VP, Clinical Development
This senior level, VP/Sr. VP/CMO position in Clinical medicine, 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 head of Clinical Development. 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.
• 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
• MD or equivalent, or medical scientist with sub-specialty training in oncology;
• Experience in clinical protocol design and implementation; experiences in I/O field a plus;
• 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 based in Guangzhou. International travel is required. Bio-Thera provides competitive compensation package including company stock.
Bio-Thera Solutions, Ltd. （www.bio-thera.com）, a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing branded biologics to treat a range of cancer and autoimmune diseases. The company has multiple candidates in clinical trials, and with early stage clinical candidates focusing on innovative targets in immuno-oncology and autoimmune diseases. To learn more about Bio-Thera, please visit www.bio-thera.com. Bio-Thera is an equal opportunity employer.