JOB DESCRIPTION :
1. Responsible for the formation, guidance and training of medical research and development team (clinical medicine research, statistics, pharmacology, drug safety alert);
2. Develops the strategies of new drugs clinical research, pipeline and clinical development assessment;
3. Supports the company's strategy, including medication registration departments, marketing departments and pre-clinical medical affairs with medical affairs. Communicate with Chinese and foreign drug regulatory review agencies
4. Guides, supports and participates in the clinical trials of new drugs: such as the choice of indications, protocol design, clinical research documents (protocol, IB, statistical analysis plan, final report, IND / NDA other medical information, etc.), writing and reviewing the medical consultation document of medical review agency;
5. KOL Communication and management of KOL and PI, development of consultation plans and medical communication plans. Provide medical support for online medical product literature publishing and product life cycle.
Competency and qualification:
Education requirements: Doctoral degree, medical or life sciences professional; industrial post-doctoral research and development training; skilled international communication skills.
Work experience requirements: At least 10 years work experience in international pharmaceutical companies, familiar with the international development of new drugs and phase 1 to 4 clinical trials; having the experience in transformation of medicine, precision medicine knowledge and clinical experience is the preferred.
Skills requirements: Ability to read professional English, familiar with the use of computers.
Quality requirement?
1Leadership, proactive and strong sense of responsibility;
2High level of enthusiasm, good coordination skills, communication skills and good team spirit;
3Strong ability to be self-binding, both the appeal and can work independently and withstand pressure;
4Integrity and preciseness;
5Have the incentive to learn new skills and to adapt to the new environment;
7 Have the courage to overcome difficulties in innovation.
Key Performance Indicators
Builds a vibrant and motivated medical team;
1. Commands and coordinates with the relevant departments to complete the new drugs clinical research strategies, indications demonstration, target product characteristics design and clinical development assessment;
2. Supervises the smooth implementation of protocol;
3. Ensure collecting the relevant clinical research data timely, completely and with high quality;
4. Maintains good communication with the investigators, the registration department and the relevant departments;
5. Takes the responsibility to cultivate young generation of clinical research and development scientists.
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https://www.credit-suisse.com/microsites/conferences/aic/en/speakers/speakers/scott-liu.html
刘世高
刘世高博士, 复星国际全球合伙人，复宏汉霖联合创始人、总裁兼首席执行官。在他的带领之下，复宏汉霖致力于应用前沿技术进行单克隆抗体生物类似药、生物改良药以及创新单抗的研发及产业化，专注于提供质高价优的生物药，已成为中国单抗领域的领跑者。在2010年组建复宏汉霖之前，刘博士曾先后担任美国UBI公司副总裁、美国百时美施贵宝（Bristol-Myers Squibb）公司及安进（Amgen）公司的质量控制总监，拥有超过25年的生技药品研发、生产制造、药政及质量管理经验。由于其杰出成就，刘博士曾获得施贵宝公司的技术运营成就奖和瞩目焦点奖。刘博士为推动国内蛋白药物质量标准建立与提升做出了具体贡献; 在国内率先引进先进的一次性生产技术用于单抗药物研发以及产业化生产; 并积极参与《生物类似药研发与评价技术指导原则》的意见征询，推动国内生物医药行业健康发展。刘博士于1991年获得美国普渡大学生物系博士学位，而后于斯坦福大学进行博士后研究，并攻读雪城大学iMBA课程。
姜伟东
姜伟东博士，复宏汉霖联合创始人兼首席科学官。姜博士曾先后在 ChemGenics (Millennium)，Microcide，Applied MolecularEvolution (Eli Lilly) 及 Catalyst Biosciences等公司担任高级科学家和总监职务，拥有多年的生物药品开发、研制、生产和管理经验，涉及抗体工程、生产细胞株及工艺优化、药政等各个方面。姜博士就读于杭州大学 (现浙江大学), 于中国科学院上海细胞所获得硕士学位，后于德国吉森大学获得微生物与分子生物学博士学位，并在美国加州大学进行博士后研究工作。
郭新军
公司高级副总裁兼董事会秘书郭新军先生毕业于上海复旦大学遗传学和遗传工程系，并拥有浙江大学管理学院MBA学位。曾先后就职于华东医疗股份有限公司、杭州九源基因工程有限公司、上海凯茂生物医药有限公司等，担任研究部经理、副总经理、总工程师等职务。郭新军先生具有多年的生物药研发、生产经验，熟悉了解国内各类法规制度，曾参与研制中国第一家上市的国家二类新药重组人粒细胞集落刺激因子（rhG-CSF）注射液，获杭州市优秀技术开发人才、浙江省科技进步二等奖、杭州市科技进步一等奖等称号。郭新军先生现担任上海市生物医药行业协会单克隆抗体药物专业委员会副主任委员。
公司高级副总裁兼首席医学官陆英明博士于美国加州大学旧金山医学院分校获得神经科学博士学位并获得临床研究专业人员协会的临床研究认证，同时拥有美国哈佛商学院MBA学位。陆博士曾先后于Spark Therapeutics、Biogen、Bayer AG、Avigen(Sanofi)、Tularik (Amgen) 等公司担任临床开发、运营高级总监及副总裁等职务，具有超过26年的全球药物开发、战略管理和临床医疗事务领导经验。2006-2009期间，陆博士也作为美国FDA临床设计委员会成员之一，专注于临床试验中自适应设计以缩短药物开发時间。陆博士早期是研究基因调控和表达，主要致力于罕见病、肿瘤病、生物制药和再生药物领域，而在他领导的遗传性视网膜、神经退行性疾病和血友病中的发展战略和执行之下, 也最近获得了美国FDA 第一个AAV基因治疗产品市场认可，现在已有15种产品获市场认可。陆博士已在科学与医学领域前沿期刊中累计发表文章50多篇，同时作为发明人申请8项专利。
-Global drug development strategist with more than 27 years of biotech/pharmaceutical experiencein multi-portfolio management to define strategy planning and pipeline growth.
-Versatile problem-solver with over 21 years of experience in program/project management.
-Decisive leader with at least 20 years of experience in global clinical development operations andglobal medical affairs championing multiple products from First-in-Human study to marketingapproval/launch.
-Relationship-builder with >18 years of experience in KOL / Patient Advocacy / Consortia / Societymanagement noted for preserving ties to clinical and scientific leaders and organizations.... See
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- Gene Therapy for Rare Genetic Diseases
- Hemophilia B (collaboration with Pfizer)
- Hemophilia A
- Choroideremia... See more
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A. Biosimilars (Oncology and Immunology)
- rituximab (approved on 2/22/2019 in China)
- trastuzumab
- adalimumab... See more
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Global Medical Affairs
- Eloctate (recombinant factor VIII Fc-fusion protein for patients with hemophilia A: from BLAsubmission to FDA approval and launch)
- Alprolix (recombinant factor IX Fc-fusion protein for patients with hemophilia B: from BL... See more
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- Extended half-life coagulation factor VIII product development:
a. Liposomal-BAY-79-4980
b. PEGylated-BAY-94-9027, Jivi
... See more
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