南京招聘

JOB PURPOSE:

Support and advice on pharmacokinetics, PK-PD and drug disposition activities for clinical projects as key member in Research & Development. Help develop the most appropriate clinical strategies with teams, present PK strategies for FIH, Population PK plans for Phase III studies and Bioequivalence and drug drug interactions protocols, as needed. Develop the clinical pharmacology sections of dossiers, write protocols, evaluate CRO and collaborator data and be responsible for PK parts of audits. Provide technical expertise to project teams, partners and CROs, as required. Work with teams to use and develop innovative PBPK models that improve PK predictions.

KEY ACCOUNTABILITIES:

？  Be an integral part of Clinical Development project teams, drive projects forward with innovative PK approaches that meet team goals.

？  Contribute to projects by conducting or interpreting PK or PK-PD analysis, so that studies are conducted at the correct dose range. Interpret and communicate data to teams, with an assessment of impact on strategy, including proposals for issue resolution.

？  Support bioequivalence studies as needed.

？  Work closely with project teams to provide appropriate, effective, and timely responses to all queries from regulators in global wise.

？  Work with Outsourcing team to provide expertise for company products PK evaluations 

？  Interface with central labs and CROs, as required for assigned projects. 

？  Provide support for CRO selection, audits, monitor studies and review reports.

？  Be a champion for DMPK and actively participate in utilizing and building PBPK models relevant to projects.

JOB-HOLDER ENTRY REQUIREMENTS:

Education:

？  A PhD in a relevant scientific field, including pharmacokinetics, drug metabolism or chemistry.

Experience & knowledge:  

？  Ten to fifteen years’ work experience, with at least five in the pharmaceutical industry, with a focus on metabolism and pharmacokinetics-related project support. Working experience in biotechnology-derived pharmaceuticals preferred.

？  A clear understanding of drug metabolism and pharmacokinetics.

？  Must be able to conduct pharmacokinetic evaluations and the ability to use PBPK models would be a plus. 

？  A good understanding of Regulatory guidance relevant to clinical pharmacology. These include NMPA, FDA and EMA guidance. 

？  Ability to effectively communicate, verbally and in writing, in English and Chinese.

Core competencies:

？  Great potential/Capability to provide DMPK and leadership to cross -functional teams at the study and or project level

？  Effective English verbal and written communication skills in relating to colleagues and associates both inside and outside the organization control approach to work

？  Ability to work effectively in a multi-cultural context as a good team member

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。