| || The CS&I group is responsible for planning and managing Phase I and Phase IIa clinical trials worldwide. NIBR trials profile safety, tolerability, pharmacokinetics, pharmacodynamics, and early proof of efficacy of novel compounds in healthy volunteers and patients. Key tasks for the CS&I group include providing scientific and operational input to study designs, leading authorship of study protocols, identifying study sites and investigators, negotiating external study contracts, coordinating study execution and data flow/scientific review, monitoring enrolment, and providing project level input and support. The CS&I Head Asia provides local group management, quality and operational oversight for a defined Clinical Sciences and Innovation (CS&I) group of Clinical Sciences Experts / Clinical Scientists (study leaders) / Clinical Trial Associates (CTA) / Trial Document Specialists (TDS) / Interns / Fellows and others (as assigned) who work to meet department goals on the execution of clinical trials in a range of therapeutic areas within Translational Medicine. Provides NIBR clinical operational expertise to the Country Pharma Organizations (CPOs) in the Asia Pacific Region and the China NIBR organization, as well as to build strong collaborations within the region.
1.Lead the team in achieving excellent execution of Translational Medicine clinical trials per agreed timelines, budget and regulatory requirements. 2.Lead the team to apply state of the art clinical research and technologies in studies.3.Work with Clinical Sciences Multi-TA managers and Therapeutic Area heads in attaining appropriate and equitable CS&I resource allocation across all therapeutic areas.4.Collaborate with all relevant CS&I managers (e.g. TA Heads) and other Line Function personnel to provide timely information regarding the scientific, strategic and operational aspects of given projects.5.Provide updates to regional and Global head and NIBR management.6.Contribute to the evaluation of clinical sites and external service providers in the Asia pacific region. Lead the identification and selection of sites for assigned indication/projects in collaboration with CPOs in AP.7.Develop strong scientific partnerships focusing on Asia pacific region to optimize scientific quality/innovation of study design, execution, reporting and publication.8.Holds group specific responsibilities, including management duties, hiring, local considerations, process improvements, use of new technologies and innovation and other responsibilities as assigned.9.Act as a Lead Clinical Scientist for assigned projects with responsibility for providing or coordinating project level documentation, regular project updates and implementation of the NIBR portion of the Clinical Development Plan. May serve as a study lead with main focus on studies conducted in Asia. 10.Contributes in the identification, evaluation and appropriate training of new centers suitable for studies/patient populations. 11.Assist in the recruitment and training of all new CS&I staff, facilitate rapid and successful integration into the team.12.Build a strong, diverse team, develop talent including potential successors, and build a highly productive organization.13.Liaison to other Line Functions (e.g. Pharmacokinetics, Biomarkers) ensuring relevant skills are developed within the local group.14.Lead cross-functional initiatives for selected new processes.15. Represent CS&I on the global review panel for the NIBR Scientific Review Committee and the TM Clinical Operations Board (COB), providing robust scientific and operational review for all TM study protocols and clinical operational plans,respectively.16.Oversight and adherence to quality standards.
| || BSc or MSc in life sciences or nursing, plus MD, PhD or PharmD level education with life sciences background. Business-level oral and written English 1. Minimum 8 years in clinical trials and drug development, including experience in early phase development in China, Asia or/and globally. 2.Demonstrated people management skills. 3.Experience in multiple clinical indications and/or therapeutic areas preferred. 4.Capable of clear written and verbal expression of ideas, an active/proactive communicator. 5.Demonstrated leadership and problem-solving skills. 6.Ability to interact with a wide range of people and build strong positive relationships and lead cross- functional initiatives. 7.High level of customer orientation awareness and focus. 8.Computer literacy. 9.Excellent organizational skills. |