南京招聘

Job Purpose

The role will serve as the pharmacology lead on a number of clinical development programs providing pharmacology support and execution of clinical development plans that include characterization and prediction of pharmacokinetics and pharmacodynamics of the drug candidate. This individual will also work in close collaboration with scientists in Translational Research and Clinical Development to conduct quantitative PK/PD/safety/efficacy analyses for integration into overall program strategies. This person will provide rationale for dose regimen selection in FIH trials and beyond, and identification of circumstances where dose adjustment or patient selection/stratification should be considered. The person will be responsible for all aspects of quantitative modeling & simulation strategies for candidate drug products from early development (pre-IND) through late stage development using model-based approaches to improve the efficiency of drug development, improve our mechanistic understanding and support dose selection.

Key Accountabilities

1.      Contributes expert pharmacology input into key pre-clinical, clinical and regulatory documents including study protocols, study reports, investigator brochures, and other documents within agreed timelines

2.      Develops PK/PD modeling and simulation plans to guide rational first in human dose projection and dose selection

3.      Leads clinical pharmacology efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results.

4.      Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan and interpreting results.

5.      Performs or oversees PK and PK / PD analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers.

6.      Serve on Global Clinical and Pre-Clinical Development Teams as Pharmacology representative and provides a source of Pharmacology expertise and advice to other functions across the Company

7.      Coordinate with clinical and translational medicine teams on strategic priorities and study support

8.      Performs other responsibilities as requested by management

9.      Provide pharmacology expertise to due diligence activities as needed.

Qualifications:

1.      A PharmD or PhD in Clinical Pharmacology, Pharmacology, Pharmacokinetics, or related discipline with at least 3 years of experience in Clinical Pharmacology and/or pre-clinical PK is required.

2.      Experience with PK/PD, allometric scaling, analysis and translational modeling of preclinical PK/PD data, and mechanism-based PK/PD systems using preclinical and/ or clinical data with biologics therapeutics is also required

3.      Demonstrated ability and experience in apply modeling and simulation approaches to enable rational and efficient preclinical and clinical drug development are required.

4.      Proficiency of the application of a broad range of quantitative tools including but not limited to WinNonLin, Phoenix, NONMEM, R and other PK/PD analysis software.

5.      Extensive experience and strong understanding of oncology drug development is preferred.

6.      Flexible, with positive attitude, ability to work with multidisciplinary teams, prioritize projects effectively and communicate at all levels within the company.

7.      Excellent written, verbal and interpersonal communication skills.

8.      Domestic and international travel will be required.

公司背景

和其瑞医药是一家科学驱动的临床阶段生物制药公司，在中国北京、上海和南京设有办公室。公司的创立是基于北京大学分子医学研究所（IMM）肖瑞平教授和她的团队对人体生物学和转化医学的深入理解与研究，依托北京大学分子医学研究所南京转化基地而生。南京转化基地是北大分子医学研究所团队携十多年潜心研究的创新成果，落户南京江北高新技术开发区建设而成，该基地将围绕“重大疾病创新药物”和“高端生物医学成像装备”两大研发方向，与北京大学分子医学研究所无缝衔接，和其瑞医药即作为基地“重大疾病创新药”研发方向的主力孵化企业之一。肖瑞平教授和娄实先生为公司联合创始人，肖瑞平教授任公司董事长和CEO，娄实先生任董事兼首席运营官。和其瑞致力于研究、开发和商业化***新药，针对流行广泛的***和***疾病，以改善生命质量为目标。目前和其瑞医药有限公司已宣布完成A轮融资，并宣布与拜耳公司（Bayer AG）就开发与产业化靶向泌乳素（PRL）受体的单克隆抗体签署一项全球独家许可协议。
依照许可协议，和其瑞医药将基于拜耳的知识产权，在全球开展靶向泌乳素（PRL）受体的全新抗体的开发和产业化。该抗体的潜在适应症包括***与***脱发症（*** and *** pattern alopecia），子宫内膜异位症（endometriosis），以及其它慢性疾病。泌乳素（PRL）受体抗体是靶向泌乳素受体的单克隆抗体，以非竞争性抑制的方式阻断泌乳素下游的信号通路。给药方式为皮下注射。该抗体I期临床试验中表现出良好的耐受性（包括单剂量和多剂量给药）。
同时研究发现这一抗体能有效促进老年红面猴头发的生长，在治疗6个月后，脱发区终末毛发的数量增长了近一倍，即使是之前近乎完全秃顶的区域，且疗效持续达停药后两年以上。这一研究是拜耳和北大分子医学研究所科学家们紧密合作的成果，未来将有望用于***及***脱发症的治疗。

团队主创人员介绍

肖瑞平（Rui-Ping Xiao）
和其瑞医药有限公司联合创始人，现任公司董事长兼首席执行官，北京大学讲席教授，北大分子医学研究所所长，《新英格兰医学杂志》副主编，曾任美国国立卫生研究院老年研究所终身研究员。

娄实 （Sam Lou）
和其瑞医药有限公司联合创始人，现任公司董事兼首席运营官，先后出任全球领先临床研发服务机构中国区总经理（PAREXEL CHINA DINGHUI），新药研发和CRO公司商务与信息副总裁（中美冠科），CMC副总裁（方达医药）；医疗器械产业化公司CEO（万东康源）。娄实先生是百华协会资深会员，同写意新药英才俱乐部副秘书长。