Job: Medical Director at ACEA Bio
Submitted by admin on Thu, 04/28/2011 - 16:23
Job Description for Medical Director at ACEA Bio (Hangzhou) Co. Ltd.
Major responsibilities:
- Managing and moving forward company¡¯s small molecular anticancer drug clinical trial programs, including phase I, phase II and phase III trials.
- Responsible for clinical protocol design and implementation, and for CRO¡¯s management.
- Participating in preclinical IND program and providing clinical inputs on regulatory affairs.
Key activities:
- Provide clinical/scientific inputs during the development and execution of clinical trials
- Interpret clinical trial data
- Participate in safety assessments
- Participate in interactions with regulatory agencies
- Prepare the required regulatory interaction documentations for clinical trials
- Identify new clinical research opportunities
- Support in-licensing and out-licensing activities and partner relationships
Qualifications
- Medical Master or Medical Doctor
- Three (3) or more years of oncology clinical trial management experience Demonstrated ability as a medical expert in a complex matrix environment
- Clinical research experience in the biopharmaceutical industry (oversea biotech, pharmaceutical or big CRO company)
- Familiarity with concepts of clinical research and clinical trial design, including biostatistics
- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and ability in applying the regulations and guidelines to international regulatory requirements
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
- Sound scientific and clinical judgment
- Good problem-solving skills
- Experience and skills in interacting with regulatory officials in SFDA
About ACEA: ACEA Biosciences, Inc. headquartered in San Diego, California is a fast-growing innovative technology development company. Recently, ACEA initiated its drug discovery business based on its unique high throughput label free cell detection system, over one million small molecule compound library, and most importantly, talented and experienced R&D team. ACEA has a wholly owned subsidiary operation (ACEA Bio (Hangzhou) Co. Ltd.) in Hangzhou, China, where a world class drug development team and facility has been established with one anticancer candidate in clinical phase I trial and three anticancer compounds in different stages of preclinical study. ACEA offers a professional, friendly, and supportive environment.
Source::
Internet