职位描述

职位描述： Job facts Job Purpose: - The Regional/Country Therapeutic Area Leader (TAL) provides therapeutic area (TA) expertise, strategic direction and operational leadership for the assigned TA, oversees the TA study portfolio and acts as the TA single point of contact for their country/region. The Regional/Country CCO TAL regularly communicates and provides TA information to the Global CCO TAL and all relevant stakeholders. - Main Responsibilities and Accountabilities: 1. Therapeutic Area Operations and Planning: - Plays a lead role in TA landscaping across region/country to establish a high level feasibility for clinical trials conducted in accordance with PDG CCO processes. - Develops and coordinates planning strategies within assigned TAs to ensure relevant clinical trial targets are met. - Provides TA leadership and work with CCO Line Manager to build effective local CSM TA teams. - Maximizes timelines and accuracy of feasibility of clinical studies and projects across assigned TAs by ensuring appropriate commitments are made to SMTs and alignment with overall global targets. - Identifies best practices and implements process improvements within assigned TAs - Contributes to local/regional/global operational effectiveness and other relevant initiatives. - Develops and drives regular updates to relevant TA plan and non-therapeutic regional/country strategic plans. - Scans the regional/country landscape to proactively identify trends and opportunities. 2. Therapeutic area project oversight: - Ensures clinical studies and projects are in conducted in accordance to local regulations, ICH-GCP and with PDG CCO local business objectives. - Maintains oversight of execution and delivery of clinical studies and projects. - Provides timely and effective issues resolution/escalation as needed. - Liaises with RH/CH Clinical Operations for agreements on country clinical study sites, patient numbers, contingency plans and general TA updates. - Delivers commitments for patient recruitment and study site activation. 3. Knowledge and Relationship Management: - Contributes to clinical operations initiatives and shares TA expertise and key information with internal and external stakeholders in a timely and thorough manner. - Maintains a thorough and current knowledge of assigned TAs including Key Opinion Leaders (KOLs)/TA Experts, patient groups, current treatment practices, patient populations, disease prevalence, current trial activities and competitor activities. - Develops and maintains relationships with key stakeholders outside of PDG-affiliate to ensure efficient coordination, communication and visibility of TA clinical studies, other projects, goals and/or issues. - Supports effective, efficient and compliant external relationship management including investigators, TA expert development. - Initiates contact with key internal/external partners/stakeholders as appropriate.Who you are You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point. Qualifications: Who you are You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point. Qualifications: - University Degree or Equivalent preferably in a medical/science-related field. - Recommended minimum of 8-10 years’ experience in Clinical Research/Development or related industry. Skills, Experience and Competencies: - 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. - Demonstrated leadership skills and ability to build relationships with external TA experts, other thought leaders, and external organizations. - Demonstrated success identifying opportunities to improve relevant processes and active support of new process implementation. - Highly organized and successfully worked in a complex environment, involving prioritizing and managing multiple tasks simultaneously. - Strong knowledge of relevant therapeutic area, ICH-GCP and local regulations throughout the relevant country/region and Roche SOPs/guidelines/quality standards. - Appreciates the diversity of working with multidisciplinary and multinational teams. - Demonstrated computer literacy, usage of MS Office software, web-based systems and databases. - Excellent communications skills including the ability to state opinions clearly in both written and spoken English, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution. - 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. - Cost & Financial Awareness – good judgment in relation to trade-offs between cost and effectiveness Other: - Availability to travel domestically and internationally if required.Who we are At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Roche is an equal opportunity employer. 职能类别： 医药技术研发管理人员 其他

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