长沙招聘

工作职责:
Role Summary:
The Development China Clinical Program Lead is responsible for leading clinical development strategy and high quality and timely delivery of interventional clinical trials for a certain therapeutic area (e.g. multiple compounds or single compound/ multiple indications) as part of the overall global clinical program for Global Product Development (GPD) or Vaccines Clinical Research and Development (VCRD). The role applies strategic thinking and collaborate with MTLs/GCLs to drive the China simultaneous development with Global. The role also applies technical excellence in the design of cost-efficient clinical trials to meet the needs of internal and external customers, ensure effective conduct and medical/scientific oversight of studies (in partnership with CTM) and support appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). The role ensures compliance with internal and external standards, proactively mitigate risk and manage emerging clinical issues.
? The Clinical Program Lead will line manage a group of approximately 2-5 Clinicians. The role will operate at the program level for a subset of the therapeutic area. S/he will ensure appropriate clinical resources and functional collaborations are deployed to studies across a clinical development program and flexed across different study areas to meet program milestones. The Clinical Program Lead is responsible for the professional development of clinicians within their group and ensures adoption of best practice across programs to grow overall team competency. This role must keep the Category Lead and Functional Head abreast of clinical progress and critical issues to support their leadership focus on decision making, capability up-leveling and stakeholder influence on the most critical issues within one or across multiple therapeutic areas.
Resources Managed (budget and FTEs):
Depending on the program, the Development China Clinical Program Lead will manage a group of 2-5 Development China Clinicians.
Responsibilities:
? Leads clinical development strategy across multiple studies and delivery for significant elements of the programs for a subset of therapeutic areas in respective category.
? Ensures that clinical trials for their program are designed and executed to the highest scientific and quality standard, and are focused on addressing the relevant technical and/or business objectives.
? Identifies and assesses program risks; creates, implements and assesses effectiveness of mitigation plans.
? Plans resources required for elements of program under his/her responsibility, in order to accomplish the clinical objectives in a timely and resource-efficient fashion.
? Responsible for the development, retention and engagement of clinical colleagues reporting to them.
? Ensures technical excellence and functional competency of Study Clinicians who report to them, through oversight, coaching, mentoring, performance management and training.
? Responsible for identifying emerging safety trends and raising them forward for further discussion with the China Category Lead/ Head of Clinical Development and/or medical monitor as appropriate.
? Maintains disease area knowledge relevant to their programs, in particular with regards to design and outcome of clinical trials for competitors. This may include responsibilities for clinical expert panel meetings and advisory board meetings to give input on clinical plans.
? Through effective collaboration with global colleagues, ensures appropriate medical and scientific expertise from different countries and regions is consistently brought to all clinical program strategy, design, execution and interpretation activities.
? Contributes to clinical preparation and attends meetings with regulatory agencies and the resolution of clinical queries from drug regulatory agencies.
? Responsible for operational excellence and timely production and approval of quality clinical deliverables for their programs, including protocols, study reports, contributions to the clinical plan and regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR), and manuscripts intended for external publication.
? Involves internal experts and consults with relevant technical advisory committees ( e.g. DC Technical Alignment Committee) to ensure high quality protocol designs and efficient clinical development plans.
? Provides clinical leadership on post-approval commitment studies including scientific design of clinical trials and Real World Evidence studies.
? Maintains a productive, collaborative relationship with a broad group of internal stakeholders (e.g. Regulatory, Statistics, Clinical Pharmacology, Portfolio and Project Management, CTM, Pharmaceutical Sciences, Safety, Medical etc.).
? Keeps China Category Lead/Head of Clinical Development informed of clinical progress and any critical clinical issues, especially those impacting the emerging benefit/risk profile.
? May support technical review of licensing opportunities, including due diligence activities.
? Ensures compliance with global and local training requirements and adherence to relevant global / local SOPs assigned to them and to the clinical colleagues reporting to them.
? May also fulfill role of Study Clinician, Medical Monitor (if applicable).
? May present to senior management, governance committees and external audiences on the clinical aspects of compound development, including milestones, strategies and data, as appropriate
? Contributes to (or leads) continuous improvement activities, and to education and training of clinical staff in areas of competence/experience.


任职资格:
Qualifications
Technical / Behavioral Competencies:
? Track record of achievement in clinical development, with a preference for exposure in disease area of relevance; demonstrate leadership in clinical development strategy and execution.
? Excellent verbal and written communication skills to build strong collaborations with internal (Global and China) and external stakeholders
? Strong scientific knowledge and broad experience in study design and data interpretation
? Experienced in reviewing the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents.
? Good understanding of China Regulatory environment and experienced in HA interactions including pre-CTA/NDA consultation meeting, panel meeting etc.
? Experienced in study execution, be able to coach/ oversight study Clinicians in study conduct esp. medical monitor activities
? Collaborative problem solving (handles conflict constructively).
? Creativity and/or ability to put innovative approaches into practice in clinical development.
? Able to embody Pfizer’s value and behaviors.
Education
Required:
? M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications.
Preferred:
? Certification /fellowship in a medical discipline or in drug development.
? Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).
Experience
Required:
? Proven track record of clinical development experience, including practical experience in clinical development strategies, and clinical trial execution.
? Track record of previous Asset Team Leader experience.
? >10 years of work experience for candidate.
Preferred:
? >7 years’ experience in Clinical development.
? Previous people management experience.
? Rheumatology and IBD TA experience.

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。