Director, Global Clinical Development, Clinical Microbiology

The Director role in Clinical Microbiology is part of the Global Clinical Development team at Otsuka and reports to the Senior Director, Global Clinical Development, OPDC.  

In this role, you will, in general, support the Global Clinical Development team working on tuberculosis (TB) drug development in contributing to our trial activity and representing our phased clinical sciences activity in cross-functional teams. This role is integral to the team and supports the development team for TB assets in clinical development and the commercial team for ongoing surveillance and other activity in marketed TB products. You will provide scientific input as well as integrate in a variety of activities such as clinical operations, product development, novel diagnostic and biomarker expertise and contribute to clinical study development, implementation, and operational activity for TB assets in clinical development.  

You will be responsible for the design and oversight of clinical research programs and protocols for Otsuka TB products under good clinical practices (GCP). You will be responsible for the evaluation and development of TB products at different stages of clinical development for a global health-care market. 

Required

Knowledge / Experience and Skills:

• Provide clinical leadership and development expertise for the microbiology procedures for the global TB program and ensure quality of the efficacy endpoint assessment at global trial sites.  
• Ensure cross-study consistency in protocol design, data analysis, and reporting, interact with expert physicians, other clinical operations staff, laboratory directors, investigators, vendor/CRO personnel, and functional area staff to ensure that the microbiology studies are run according to ICH, FDA, and OPDC guidelines, and ensure compliance with FDA and international regulations, GCP/GCLP, and SOPs.  
• Collaborate with our preclinical research team to develop a regulatory strategy from a microbiological perspective 
• Act as one of the key microbiology contacts for all protocols, including contributing to the development and implementation of project strategy.  
• Provide historical knowledge and expertise of TB clinical trials to lead the generation of microbiology reports for regulatory submissions.  
• Perform, when required, qualification visits for mycobacteriology laboratories to determine readiness for performing clinical trials; identify shortfalls and create action plans to prepare laboratories for clinical trial work.  
• Design standardized laboratory manuals and standard operating procedures for each clinical trial(s) to ensure comparability for efficacy analyses.  
• Research validation and methodology for clinical trial endpoints.  
• Coordinate with local microbiology experts in their conduct of day-to-day operations of clinical trials, including: 

• Review of reports from microbiology consultants (local consultants assigned to each lab).  
• Management of sites; create and review study-related tracking (enrolment, monitoring, regulatory documents, etc.); review of clinical site monitoring reports; review of site-generated data for accuracy and consistency.  

• Advisor to CRAs to identify problems and propose solutions to maintain projects within designated timelines and budgets.  
• Update risk mitigation strategies for the mycobacteriology laboratories and implement solutions to maintain projects within designated timelines and budgets.  
• Supervise reviews of tables and listings, missing pages reports, enrolment progress reports, and regular microbiology data reviews to ensure data integrity and review trending & consistency across sites. Troubleshoots inconsistent/problematic data with MGIT and LJ cultures and drug susceptibility testing Prepare and review microbiology sections for protocol development, clinical study reports, publications, and regulatory submission documents.  
• Support TB program inspection readiness strategies.  
• Lead the organization, preparation, presentation, issue identification, and follow-up for all portions of investigator and global team meetings related to microbiology.  
• Coordinate microbiology training programs for directors, CRAs, lab consultants and investigator meetings.  
• Review TB risk reduction strategy for new vendors.  
• Troubleshoot and monitor contamination rates in trial laboratories.  
• Lead the authoring, review and approval of early phase and microbiological information response documents.  
• Represent the company at applicable national and international conferences strengthening the reputation of Otsuka.  
• Consult with patients