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
劉世高
劉世高博士, 複星國際全球合夥人，複宏漢霖聯合創始人、總裁兼首席執行官。在他的帶領之下，複宏漢霖致力於應用前沿技術進行單克隆抗體生物類似藥、生物改良藥以及創新單抗的研發及產業化，專注於提供質高價優的生物藥，已成為中國單抗領域的領跑者。在2010年組建複宏漢霖之前，劉博士曾先後擔任美國UBI公司副總裁、美國百時美施貴寶（Bristol-Myers Squibb）公司及安進（Amgen）公司的質量控製總監，擁有超過25年的生技藥品研發、生產製造、藥政及質量管理經驗。由於其傑出成就，劉博士曾獲得施貴寶公司的技術運營成就獎和矚目焦點獎。劉博士為推動國內蛋白藥物質量標準建立與提升做出了具體貢獻; 在國內率先引進先進的一次性生產技術用於單抗藥物研發以及產業化生產; 並積極參與《生物類似藥研發與評價技術指導原則》的意見征詢，推動國內生物醫藥行業健康發展。劉博士於1991年獲得美國普渡大學生物係博士學位，而後於斯坦福大學進行博士後研究，並攻讀雪城大學iMBA課程。
薑偉東
薑偉東博士，複宏漢霖聯合創始人兼首席科學官。薑博士曾先後在 ChemGenics (Millennium)，Microcide，Applied MolecularEvolution (Eli Lilly) 及 Catalyst Biosciences等公司擔任高級科學家和總監職務，擁有多年的生物藥品開發、研製、生產和管理經驗，涉及抗體工程、生產細胞株及工藝優化、藥政等各個方麵。薑博士就讀於杭州大學 (現浙江大學), 於中國科學院上海細胞所獲得碩士學位，後於德國吉森大學獲得微生物與分子生物學博士學位，並在美國加州大學進行博士後研究工作。
郭新軍
公司高級副總裁兼董事會秘書郭新軍先生畢業於上海複旦大學遺傳學和遺傳工程係，並擁有浙江大學管理學院MBA學位。曾先後就職於華東醫療股份有限公司、杭州九源基因工程有限公司、上海凱茂生物醫藥有限公司等，擔任研究部經理、副總經理、總工程師等職務。郭新軍先生具有多年的生物藥研發、生產經驗，熟悉了解國內各類法規製度，曾參與研製中國第一家上市的國家二類新藥重組人粒細胞集落刺激因子（rhG-CSF）注射液，獲杭州市優秀技術開發人才、浙江省科技進步二等獎、杭州市科技進步一等獎等稱號。郭新軍先生現擔任上海市生物醫藥行業協會單克隆抗體藥物專業委員會副主任委員。
公司高級副總裁兼首席醫學官陸英明博士於美國加州大學舊金山醫學院分校獲得神經科學博士學位並獲得臨床研究專業人員協會的臨床研究認證，同時擁有美國哈佛商學院MBA學位。陸博士曾先後於Spark Therapeutics、Biogen、Bayer AG、Avigen(Sanofi)、Tularik (Amgen) 等公司擔任臨床開發、運營高級總監及副總裁等職務，具有超過26年的全球藥物開發、戰略管理和臨床醫療事務領導經驗。2006-2009期間，陸博士也作為美國FDA臨床設計委員會成員之一，專注於臨床試驗中自適應設計以縮短藥物開發時間。陸博士早期是研究基因調控和表達，主要致力於罕見病、腫瘤病、生物製藥和再生藥物領域，而在他領導的遺傳性視網膜、神經退行性疾病和血友病中的發展戰略和執行之下, 也最近獲得了美國FDA 第一個AAV基因治療產品市場認可，現在已有15種產品獲市場認可。陸博士已在科學與醫學領域前沿期刊中累計發表文章50多篇，同時作為發明人申請8項專利。
-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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