上海招聘

Product Development in Asia Pacific (PDY)
Job Description
Position: Country Head of China
Division:Product Development
Department:Country Clinical Operation (CCO), Product Development Global Operations (PDG)
Location:Shanghai or Beijing (preferred in Shanghai), China
Reports to:AP Regional Head of CCO

Basic Function:

To provide leadership and manage the CCO-China Team so that study commitments are met in accordance with protocols, patient numbers, timelines and budgets as set by SMTs and in respect of the functional budget. To ensure that all studies conducted by the CCO are undertaken according to ICH/GCP standards, Roche SOPs and quality standards, local operating guidelines and local regulatory requirements. To partner with the other PDY functional departments and Roche Shanghai business departments to create synergy and maximize value of Product Development studies to business regarding study implementation and site selection.

Primary Responsibilities include:

Provides Direction and Leadership to the PDGA-China Team
Builds an effective, high performing team through influence, integration, motivation and optimization. Embeds the Roche values into the team culture and promotes the team spirit
· Provides leadership and strategic direction for CCO in line with the PDG Vision and Mission, taking into account the local business needs and priorities
· Leads the CCO-China Management Team and manages the CCO-China Team Leaders with the objective of enhancing quality, productivity and efficiency
· Ensures that each team member is aware of his/her specific area of accountability and responsibility within the CCO-China and that updated job descriptions are available
· Accountable for overall CCO-China performance as defined by functional goals
· Communicates regularly on country studies status and escalates unresolved or unexpected issues appropriately to the CCO-AP Regional Head
· Participates on the CCO-AP Regional Management Team to help provide direction for the regional group and shares accountability with other CCO Country Heads for the performance of the CCO network
· Identifies areas of Best Practice and Process improvements within the CCO-China

Ensures projects and studies activities are conducted in accordance with PDG needs
· Ensure regular reviews of projects to identify future studies
· Ensures appropriate project, protocol and site feasibility is undertaken in the CCO-China so that the studies, once placed, recruit according to the commitments that have been made. Check that the affiliate feedback is entered into relevant business systems at each step of the feasibility process
· Review and approve all local study commitments and ensure that they are in line with SMT expectations. Ensure all local study team (LST) goals are set in alignment with these commitments
· Monitors progress against LST goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams
· Ensures appropriate resources are assigned to the studies in a timely fashion to allow for optimal conduct of the study
· Ensures all CCO-China ethical and administrative submissions are made in accordance with timelines and local requirements (including regulatory activities if appropriate) and all appropriate actions are in place for effective study start up
· Review on an on-going basis all Business Indicators (study start-up, recruitment metrics, data flow, CTMS, Goblet, Planning System resource assignment, timesheet data, etc) to allow for proactive identification of issues.
· Ensures that all action plans (training, study start-up, recruitment, contingency) are delivered in accordance with SMT expectations and, for all projects, the delivery of study activities meet the study plans
· When studies are globally outsourced to preferred partners, ensure an appropriate CSM support and a local effective communication plan, if needed, are in place to maintain and develop the Roche Global CRO partnership
· Develops and maintains investigator/customer relations, builds and maintains a professional relationship between Roche and investigator/customer

Manages the budget and resources in accordance with project needs
· Accountable for setting, managing and updating the CCO-China functional budget and resources according to the corporate and PDG processes (four budget rounds per year)
· Review all the CCO-China Planning System plans on a regular basis. Ensure that each local study plan is adequately resourced to effectively deliver high quality studies on time and within budget, according to the SMT goals
· Check that the resources submitted at each budget round are consistent with the planned resources as entered into Planning System
· Ensures an adequate balance between the Roche headcount (permanent or temporary) and the contract headcount


Ensures all studies which are conducted in the CCO-China are undertaken in accordance to ICH/GCP standards, Roche SOPs and quality standards, local operating guidelines and local regulatory requirements
· Ensures a constant support from the local Compliance & Training Group
· Actively promotes PDG standards, procedures and Best Practices. Ensures that Best Practices are shared across the team
· Ensures all CCO-China staffs are appropriately trained and supported via the Compliance and Training Network regarding the Roche international and local procedures, including co-monitoring visits, if needed
· Ensures CSMs and monitors receive appropriate therapeutic area and study specific training
· Review the local compliance visit planning and check that new monitors or CSMs are listed in
· Review local audit findings and ensure that appropriate follow-up action(s) are taken as required

Interactions with local business
· Ensures that the other PDY functions and Roche Shanghai are fully supported by CCO-China (interactions with Regulatory Authorities, Key Opinion Leader Development, local and global congresses, local committees)
· Develops and maintains effective working relationships with all operational departments of Roche Shanghai, e.g. Business Units, Medical Department
· Ensures a good communication plan with Business regarding study implementation, site and KOL selection
· Participates in local Business meetings as necessary
· Ensures Business is fully aware of planned activities in the clinical development portfolio

People management and Career Development
· Responsible for the Performance Management and Career Development of all CCO-China staffs in accordance with PD, PDG and local site/HR requirements
· Ensures that the performance of CCO-China employees is proactively managed and they are coached, trained and developed in order to maximize their contribution
· Ensures that all CCO-China staffs have goals in place and that these are assessed on a regular basis throughout the year (mid-year and end-year review)
· Develops and maintains job and role descriptions, competency frameworks and development paths to meet current and future business needs of CCO
· Ensures that all CCO-China staffs have individual development plans in place with appropriate actions for effective career development
· Identifies future needs for resource and identifies, recruits, trains and develops high potentials and appropriate talents

Qualifications and related competencies:

Qualifications
· University degree or equivalent in a medical/science-related field

Experience
· Extensive (~10 years) experience in clinical development in an international environment, preferably in more than one major R&D-based Pharma company
· Knowledge of international and/or local regulatory requirements for conducting clinical trials
· A track record of successfully working in a complex international environment, involving managing multiple tasks and competing priorities simultaneously
· Strong leadership skills including experience of managing staffs and/or experience of leading multi-functional matrix study development teams
· Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans
· Able to work in a complex environment, to prioritize and manage multiple tasks and to develop excellent working relationships
· Experience of interaction with global/local Business Units and/or good understanding of global/local Business needs
· Experience in influencing and negotiating at all levels to achieve team delivery in accordance with commitments
· Demonstrated success in setting and delivering departmental goals and managing performance through reliable business indicators
· Demonstrated success in identifying opportunities to improve and in implementing new business processes

Knowledge
· Complete knowledge of ICH GCP
· Detailed knowledge of all aspects of Clinical Trial management
· Familiarity with the therapeutic areas that are priorities for Roche


Competencies
· Decision Making - able to make sound, timely, decisions within areas of own responsibility and recognizes when and how other stakeholders need to be involved
· Collaboration and Teamwork - successful and comfortable working in a complex international matrix
· Good at handling conflict and high-level negotiation skills
· Skills to lead people through major change
· Project Management - familiarity with project management software, spreadsheets, PowerPoint and word-processing tools
· Communication - excellent written and verbal communication skills, demonstrated by an ability to present clear messages from complex information/data to all levels in the organization
· Personal Organization - highly organized, excellent ability to prioritize own tasks
· Cost and financial awareness - good judgment in relation to trade-offs between cost and effectiveness
· Fluency in written and spoken English


The statements made here are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

罗氏药品临床研发亚太中心

罗氏药品临床研发亚太中心位于上海张江高科技园区，是罗氏在中国乃至亚太地区（不包括日本在内）第一个全功能临床药品开发中心，是罗氏药品开发部在全球的第五个研发地区。其前身为2007年10月成立的罗氏药品开发中国中心。

罗氏于2007年在中国率先设立全球药品开发中心，成为在华完成且体现药物研究、药品开发、生产制造和市场销售环节等整体价值链布局的跨国制药企业。此举不仅将加快新药在华的上市时间，使国内广大患者有望更早地受益于创新药物，而且将让更多的中国研究机构、学者、临床医生更早、更主动地参与到全球创新药物的开发过程。

罗氏药品开发中国中心从事药品开发工作，是把经过实验室筛选的分子转变成药物的关键一环，它通过国际多中心临床研究，鉴定药物的安全性和有效性，是驱动药物价值链的引擎。罗氏药品开发中国中心于2009年9月升级为罗氏药品临床研发亚太中心，负责罗氏在亚太地区的药品开发，令更多中国乃至亚太地区的患者尽早受益。