北京招聘

Responsibilities include:

? Leads clinical programs in partnership with Clinical Operations from the IND-enabling stage through Phase 2 proof-of-concept.

? Designs and implements clinical research strategies and is accountable for the development and execution of clinical research programs for novel agents in a variety of therapeutic areas and disease states.

? Directs study design, protocol development and implementation of clinical studies. Partners with Clinical Operations to define clinical study parameters, deliverables, and resource needs. Participate in study recruitment efforts, enrollment, help interpret study results and present it internally and all partners externally or the study investigators.

? Reviews and evaluates clinical research results to inform development strategy, operational tactics and future marketability. Safeguards compliance and internal and external standards, proactively mitigates risk and manages emerging clinical issues.

? Serves as the medical monitor for a set of portfolio assets.

? Oversees evaluation of adverse events for overall assessment of benefit-risk.

? Contributes to the preparation of submission documents for INDs and CTAs to regulatory agencies. support appropriate interpretation and communication of clinical trial data including high quality regulatory submissions and protocol defense activities

? Acts as the primary point of contact with external partners, investigators and the internal study team for questions related to clinical/ medical aspect of the protocol.

? Ensures that all activities are in compliance with GCP’s and company SOPs.

? Represents CANbridge at key international and national medical and scientific meetings including participation and/or leadership of advisory boards with key option leaders

? Collaborates closely with Business Development colleagues in providing scientific/medical assessment and strategic input strategic on potential pre-clinical and clinical in-license opportunities

Candidate Specification & Key Selection Criteria:

Minimum Requirements:

? MD or MD-PhD with a minimum of 5 years’ industry experience in a global biotech or biopharmaceutical environment is required. Industry experience should include translational medicine with early stage drug development experience preferred. Experience with Oncology or Rare Disease therapeutic areas preferred but not required.

? Experience in conducting and executing clinical trials (recruitment, investigator performance and investigator site relations) on a global basis, with preference for China and South East Asia experience.

? Demonstrated knowledge of and a track record of developing and providing oversight for clinical trial strategies, methods and processes either small molecule or biologics, is required.

? Proven track record of proactive management of regulatory issues related to protocol s and programs, including comprehensive experience of interaction with regulatory authorities

? Experience interacting with regulatory authorities in Asia such as CFDA is a plus.

? Thorough knowledge of clinical research concepts, practices, and GCP & ICH

Capabilities/ Skills:

? Possess self-motivation, creativity and a willingness to take a “roll-up the sleeves” approach to operating in a start-up environment where processes and procedures may not yet be in place. .

? Proven ability to get results in a virtual environment with internal colleagues in multiple locations

? Demonstrated ability to design, initiate and conduct clinical studies in industry, academic, or research clinical setting

? Proven scientific writing skills, including ability to evaluate, interpret and present complex clinical data

? Demonstrated ability to review and understand the emerging safety and efficacy profile of a drug candidate; part of this skill is putting the profile in perspective with comparator agents

? Collaborative problem solving skills (handles conflict constructively)

? Creativity and/ or ability to put innovative approaches into practice in clinical development

? Able to discuss investigator performance issues, coach and/ or mentor clinical investigator site staff to achieve operational and recruitment goals and quality standards

北海康成（北京）医药科技有限公司正式成立于2012年6月，总部设立在中关村望京科技创业园区内。
北海康成致力于解决满足“三个需求”，即满足中国患者对高效药物的需求、中国药企关键技术、产品更新换代的需求、发达国家中小生物制药企业进入中国市场的需求。
北海康成通过技术转让、吸收和再创新对接世界最大的生命高科技医药产品线与全球增长最快、潜力最大的应用市场。公司引进、研发、上市的重点是中国和亚洲市场所急需的特效药物。北海康成已经与欧美创新型生物制药公司、研究机构开展多个抗癌药物领域的技术合作。公司注重临床后期新药开发，有针对性地获取尖端的或国内新药研发所急需的制剂和生产工艺方面的成果，通过再创新和技术转化研发上市拥有自主知识产权的医药产品。