长沙招聘

Clinical Pharmacology Leader

At Johnson & Johnson we are recruiting for a Clinical Pharmacology Leader (Manager) for our China R&D center, based both in Shanghai/ Beijing. Our vision is to have a fully integrated end-to-end R&D organization in Asia that innovates and develops products in Asia that delivers significant benefits to patients in the region and globally. To achieve this vision, we will implement a strategy with three major pillars:
?continue our expansion of R&D functions into the regions to service global and regional programs
?form strong regional Compound Development Teams to innovate and develop compounds
?initiate an active Open Innovation platform through External Research to enrich our pipeline of innovative products

Job summary
The position is responsible for developing clinical pharmacology programs, and delivering quantitative pharmacology and modeling/simulation supports to discovery and development of both small molecules & biologics, from pre-New Molecular Entity (NME) declaration through post-marketing development in China R&D organization. The responsibilities also include active participation in Clinical Teams/Compound Development Teams

Responsibilities
?Responsible for designing, developing and implementing clinical pharmacology plans and strategies for supporting end-to-end projects initiated by China R&D. Responsible for the design of studies to evaluate candidate drugs’ pharmarcokinetics (PK) and pharmacodynamics (PD) clinically
?Responsible for providing Clin Pharm contributions to China/AP regulatory submissions and approvals: Designing & conducting bridging China/AP PKPD studies, providing strategic supports in liaison with global Clin Pharm
?Responsible for delivering quantitative pharmacology and modeling & simulation supports to discovery of both small molecules & biologics, early to late clinical development, and post-marketing development in China R&D organization. Work collaboratively with key functional partners and apply quantitative ClinPharm tools to guide NME selection, dose / dose regimen selection, predict clinical response and study outcomes, and to optimize study design
?With guidance from ClinPharm Head, provide appropriate dosing recommendations for special populations (eg, drug interaction, food effect, pharmacogenomic effect, pediatric, elderly)
?Has overall scientific accountability for ClinPharm studies, ClinPharm components of other studies and modelling & simulation components.
?With guidance from ClinPharm Head, prepare ClinPharm contributions to regulatory documents including IBs, End of Phase 2a / 2 meetings, NDA / MAA submissions, postapproval filings, and responses to regulatory questions
?Responsible for the consistency, quality, compliance, and timeliness of clinical PK and PK/PD input into Phase I to III protocols, data analysis, and PK and PK/PD sections of investigator brochures, study reports, regulatory documents, and other documents in accordance with general standards, guidelines, and processes
?Serves as member of the Clinical Development Team and Compound Development Team, where appropiate, for all clinical PK and PK/PD aspects of development projects and programs
?Contributes to the identification, characterization, and validation of potential biomarkers and/or surrogate markers and measurements in non-clinical and clinical studies
?Assist in evaluation of in-licensing opportunities for clinical PK and PK/PD components
?Present and / or publish scientific data at conferences and in peer-reviewed journals
?Stay abreast of new emerging technologies in relevant scientific fields
?Liaise with key functional partners to provide product differentiation strategies based on a compound's key ClinPharm attributes
?Maintain compliance with Credo standards, Health Care Compliance, and Business Integrity

Minimum Qualifications / Experiences
?MS or Pharm D degrees with 5 years of pharmaceutical development experience
?PhD or equivalent degrees with 3 years of pharmaceutical development experience

Minimum Technical Knowledge and Skills
?Demonstrated competency in PK/PD modeling & simulation
?Experience in the use of WinNonlin, NONMEM, R or S-plus, database management, or related scientific software
?Working knowledge of Clinical Pharmacology, PK/PD modeling concepts and basic statistics
?Good understanding of clinical drug development and the overall pharmaceutical R&D process
?Working knowledge of US, European, and Asian regulatory requirements and guidelines
?Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area(s)
?Ability to lead and / or oversee multiple smaller ClinPharm programs
?Has established a good level of expertise and scientific reputation through publications and presentations

Minimum Non-Technical Competencies and Skills
?Fluent in written and spoken English
?Good written and oral communication skills and able to communicate effectively with individuals and groups in the organization (communication)
?Ability to build and maintain effective working relationships inside and outside the department; strong aptitude for working in a cross-functional team environment; demonstrates commitment to team's expectations and decisions (building strategic working relationships)
?Ability to multi-task, prioritize assignments, and work under pressure, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organization, managing the job)
?Assume responsibility and accountability for successfully completing assignments or tasks, proactively taking action to accomplish objectives, and setting high standards of performance (delivery of results)
?Ability to diagnose issues and problems, develop alternative solutions, take decisions, and act with a sense of urgency; exercises good judgment in assessing situations and deciding next steps (decision making)
?Good sense of cultural sensitivity and diversity (cultural diversity)
?Actively identify new areas for learning and application to the job (continuous learning)
?Self-motivated and able to work independently with minimal supervision (personal accountability)
?Understands the broader development organization
?Ability to inspire, motivate, and provide effective leadership to team members
?Courage to stand alone on ideas and opinions which differ from others; takes risks where necessary (prudent risk taking)

Other Requirements
?Estimated travel of about 10% - 15% of time

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国***的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。

本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。

目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。

2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。