上海招聘

Purpose: To strengthen the therapeutic area focus of CCO at the country level, thus being more effective in the portfolio delivery and strategic planning:
l The Clinical Operations TAM provides strategic and operational leadership to the Therapeutic Area Affiliate Study Portfolio:
l Has oversight of Study Management Team (SMT) goals on studies under assigned therapeutic area(s)
l Ensures relevant SMT goals are on track to achieve targets and contingency plans are in place to be acted upon when required
l Establishes and maintains effective working relationships with Roche local, regional and global functions as well as external contacts across the region.
l Provides timely and regular updates to CCO China Country Head and CCO Global Therapeutic Area Lead (CCO-TAL)

Areas of Focus: 1) Oncology; 2) Metabolic Disorders & CNS; 3) Immunology & Infectious Diseases

The CCO Therapeutic Area Manager (TAM)
l Is a member of CCO China management team
l Is a member of the CCO TAM network along with CCO TAL.
l Provides strategic and operational expertise to the product development strategy of assigned therapeutic area(s)


Principle Roles & Responsibilities / Accountabilities 主要职责/责任 (Major functions of the position) （职位的首要职能）

1. Helping ensure SMT goals for assigned therapeutic area(s) are met, with focus on patient recruitment and study site activation
2. Provides therapeutic area expertise and strategic operational input to PDY development strategies in assigned TAs
3. Continuously enhances his/her therapeutic area, disease state, product and general business knowledge
4. Establishes and maintains key internal and external contacts and relationships, locally, regionally and globally
5. Oversees relevant disease area training for staff in China

Therapeutic Area clinical operations planning & development
？ Plays a lead role in therapeutic area landscaping in China to establish high-level feasibility for clinical trials conducted in accordance with PDG, pRED and gRED
？ Develops and coordinates planning strategies within assigned therapeutic area(s) to ensure relevant clinical targets are met and that best practice is incorporated and shared
？ Provides therapeutic area leadership and builds effective local CSM Therapeutic Area Teams
？ Maximizes timelines and accuracy of feasibility of clinical studies and projects across assigned therapeutic area(s) by ensuring appropriate commitments are made to SMTs and alignment with overall blueprint targets
？ Identifying best practices and implementing process improvements within assigned therapeutic area(s) and contributing to local, regional and global operational effectiveness and other relevant initiatives
？ Develops and drives regular updates to relevant regional Therapeutic Area Plan and non-therapeutic specific regional strategic plans

Therapeutic Area clinical studies/projects oversight
？ Responsible to ensure clinical studies and projects are conducted in accordance with PDG and local business objectives
？ Maintains oversight of execution and delivery of clinical studies and projects and provides timely and effective issues resolution and/or escalation where necessary
？ Regularly liaises with Country Head, Clinical Research Managers &/or CCO TAL, for agreements on country clinical study sites, patient numbers, contingency plans and general therapeutic area updates
？ Responsible to deliver commitments for patient recruitment and study site activation

Knowledge & relationship management
？ Contributes clinical operations and therapeutic area expertise to all activities and involved partners/stakeholders. Includes ensuring key information and learning are shared in a timely and thorough manner
？ Maintains a thorough and current knowledge of assigned therapeutic area(s). Includes KOLs, current treatment practices, patient populations, disease prevalence, current clinical trial activities and competitor activities
？ Develops and maintains internal contacts outside of PDG-CCO to ensure efficient coordination, communication and visibility of therapeutic area clinical studies, other projects, goals and/or issues
？ Supports effective, efficient and compliant external relationship management, including investigators, KOL development and the like
？ Initiates contact with key internal/external partners/stakeholders as appropriate. Arranges meetings and other communications as needed
？ Represents Roche in interactions with investigators

2. Qualification and Experience 能力与经验

Education/Qualifications教育程度/所获资格证书
？ Bachelor degree or above in a medical/science-related field, higher degree with medical or/and scientific training is a plus

Experience
？ Extensive knowledge of the overall drug development process relevant to pharmaceutical/biotechnology organizations
？ Experience in development and implementation of clinical trials (includes extensive experience in the operational aspects of national/international clinical studies of different phases of drug development, including development, implementation and management of risk management plans, management of complex study budgets and resourcing plans)
？ Experience in the principles and techniques of data analysis, interpretation, and clinical relevance
？ Previous experience as a CSM or similar role
？ Demonstrated ability to build relationships with external KOLs, other thought leaders, and external organizations
？ Demonstrated success identifying opportunities to improve relevant processes and active support of new process implementation
？ Successfully worked in a complex environment, involving prioritizing and managing multiple tasks simultaneously

Knowledge
？ Strong knowledge of relevant therapeutic area
？ Strong knowledge of ICH-GCP and local regulations throughout his/her region and Roche SOPs/guidelines/quality standards
？ Detailed knowledge of all operational aspects of clinical trial management
？ Appreciates the diversity of working with multidisciplinary and multinational teams
？ MS office literate
？ Fluent English language knowledge, written and verbal

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 in a complex international matrix environment
？ Project Management – strong project management skills and familiarity with project management software
？ Communication – excellent written and verbal communication skills, demonstrated by 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 & Financial Awareness – good judgment in relation to trade-offs between cost and effectiveness

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。