Guobin WANG

Involve company strategy and pipeline development decision as senior management; Communicate with external strategic partner in terms of project development and delivery status; Achieved the 1st pivotal trial NDA success; Oversee key oncology projects delivery including Glioblastoma, NSCLC, pancreatic cancer, malignant pleural mesothelioma, biliary tract cancer, NSCLC with brain metastases etc.，deeply involve projects and visit sites to solve key and complicated issues personally as appropriate; Set up comprehensive right site selection guideline; Develop recruitment acceleration general guideline, customize project specific site&patient profile achieving remarkable success: recruitment rate is 3 times as industry level in one oncology trial; Intensively visit KOLs in different therapy fields, GCP directors and EC officers to enhance relationship and expedite project delivery; Set up comprehensively quantitative project management KPI and implement in all projects, tracking team and vendors’performance; Define department culture in terms of outcome-oriented, professional and team-player; Generate SOP framework and guide team on SOP development, training materials and internal administration tools and system from zero；Personally develop key SOPs and training materials; Guide line managers to set up comprehensive KPI for teams’performance review; Integrate resources and optimize processes with medical team for seamless cooperation to improve project quality and execution efficiency; Create & streamline cross function cooperation processes and SOP; Enhance collaboration with internal cross functions including R&D, translational medicine, quality, manufacture and supply chain etc.; Set up vendor selection strategy, processes and assessment criteria; Outsource trials to CRO and approve clinical trial budget;

Build up clinical operation function & team including PM, CRA, SSU, CTA, QM; Lead bid defence for a big size ophthalmology trial from feasibility, KOL interview and site selection, slide preparation, BDM presentation and win the opportunity; Set up business related SOP, systems, and processes; Lead clinical operation functions, ensure the functions can smoothly meet or outperform the function’s goals, all the business activities comply with GCP, Chinese legal/regulatory requirements and the Company’s policies and SOPs; Design and lead innovative clinical services as company’s key emerging business to differentiate from competitors; Visit KOLs and top hospitals’ GCP officers to facilitate project delivery; Enhance relationship with clients to support business expansion; Oversee key clients and pivotal projects in breast cancer, Thymic carcinoma, lymphoma，diabetes etc.

Coordinate with global PM groups to build up China PM team； Solve a crisis of strategic partnership with one of top 10 MNC by rescuing project delivery in China; Oversee key client accounts and early engage in client program development plan; Present China regulatory and clinical operation insights to PPD global executive management and US based biotech companies； Support business expansion in China.

Build up dedicated project delivery team from the scratch including study manager, CRA and CTA； Develop BDU development strategy; Develop BDU study manager onboarding manual and training plan including technical and softskill assets; Generate BDU branding materials and present to APAC cross-functions; Design subject matter expert roadmap covering people management, project management, finance, RA, start-up, quality management, project assistant and tools/systems usage; Act as liaison with global PM training team, APAC PM and strategic lead group to leverage Quintiles global & regional resources and experiences; Work with global tool/system administrators to integrate BDU requirements into project management tools.

Rescue one project which drew client CEO and Quintiles president concerns about the study quality. Win back the client confidence to Quintiles and enhance good rapport with client China, regional and headquarter; Manage PMs and project assistants as LM in accordance with organization’s policies and applicable regulations; Oversee key MNC clients involving from strategically early engagement to proposal development; attending regional & China client-CRO senior joint oversight committee meeting; oversee project delivery for oncology, GI and CNS phase I to III studies; Great China regional resourcing manager to coordinate and assign PMs for bid defence meeting and PM replacement etc.; Being China oncology PM team lead liaising with regional oncology group head； Serve as primary PM function contact point for internal cross-functions and external clients to ensure appropriate communication channels are maintained and questions addressed; Streamline working instructions/processes working with cross-functions following China regulations; Organize and host Great China Region PM function monthly office meeting; Lead BD proposal development and face-to-face BD presentations as project director.

Administrative Management Experience Jointly host and pass the FDA inspection with NO findings (NO Form 483); Complete a challenging recruitment in China in 3 months accounting for 20% of global recruitment; Act as global & regional PM to manage studies involving 9 countries in APAC; Manage & mentor PMs, CRAs and CTAs on resource allocation, performance review and experience sharing; Act as PM team lead to interact with cross functions to streamline procedures; Summarize knowledge and practices of conducting clinical trial in China to corporate executive management for international conferences; Develop training materials and deliver the training to global & regional PMs; Deliver project management presentation to external PM peers cross China through DIA PM Saloon; Prepare and attend client QA office audits and client office visits; Lead feasibility, BD activities and attend project bid defense meetings as key leader.

Project Management Experience: HIV Phase IIb 2 countries 8 sites Aug 2011 to Feb 2014 Responsibilities: Regional PM responsible for Australia and Thailand; Liaised with client global and hubs and external vendors Oncology Phase III 7 countries 39 sites May 2011 to Feb 2014 Responsibilities: Regional PM responsible for 39 sites from 7 countries in APAC. PAH Phase III 18 countries 60 sites Dec 2009 to Feb 2014 Responsibilities: China PM responsible for 3 protocols coordinating with sponsor in US; Alzheimer’s Disease Phase III 5 countries 24 sites May 2010 to Dec 2012 Responsibilities: Global PM to interact with sponsor and external vendors in US

Administrative Management Experience Build up China operation department and team; Take over a delayed study and catch up the progress; generate CSR for CFDA submission, pass the CFDA review in one time and obtain the approval; Rescue a study in the condition of coming IP expiry and CFDA approval pending; Adapt SOP system for China team; Design operational training materials; Proactively involve in regulatory affairs activities; China contact point for global R&D, clinical operation and QA departments; Involve in product pipeline discussion as Asia Pacific strategic key team member; Coordinate with AP cross-functional departments: R&D, RA and S&M; Enhance positive relationship with KOLs; Evaluate external service vendors: QA, IP depot and DM & bio-statistic analysis; Provide training to Sales & Marketing team.

Project Management Experience: Specific Immunotherapy Phase Ⅰ 1 site & 24 subjects Responsibilities: Accountable for budget proposal and control, protocol and CRF design, IP label design, DM negotiation, accompanied site visit from study start-up through project close-out Specific Immunotherapy Phase III 3 sites & 413 subjects Responsibilities: Take over the delayed study from the middle and fill up the gap Specific Immunotherapy Phase III 18 sites & 600 subjects Responsibilities: Responsible for the trial from zero: budget initiative and negotiation with HQ, protocol and CRF design. IP batch size calculation, IP label and randomization design, project timeline development, convinced sites to offer EC conditional approval, organized and hosted the Investigator’s Meeting

Coordinate between internal departments: QC, QA and plant;  Initiate and implement validation protocols;  Generate validation reports and reshuffle SOPs.

Involve multiple global projects from feasibility throughout close-out;  Train and mentor local junior team members;  Manage all office documents;  Involve in HQ’s audit for a Chinese pharmaceutical company in compliance with FDA cGMP.

Quality Manager Nov 1995 – Sep 1999  Led internal audit for pre-CFDA GMP inspection and obtained the GMP license;  Involved in establishment of a new GMP company as key player, set up lab;  Initiated, reviewed and approved SOP; R&D Leader Jul 1992 – Oct 1995  Acted as PM Responsible for clinical trials in cardiovascular and infectious diseases;  Key player involving in pre-clinical development and regulatory affair activities.