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 microbiologicalinformation response documents.
• Represent the company at applicable national and international conferences strengthening the reputation of Otsuka.
• Consult with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully apply their recommendations toward optimizing trial objectives, designs and protocols.
• Expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.
• Authors program strategies (i.e., GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.
• Interprets and communicates results of Phase I-IV investigations in preparation for a new drug.
• Acts as the signatory on clinical study and safety documents.
• Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.
• Provides strategic oversight in our vendor and CRO relationships and provides clinical input into their governance committees.
• Will help lead and support regulatory filing activities and documents. Providing strategic direction and editing to provide concise, clear and convincing argumentation in all such written and verbal communications.

Qualifications:

• A clinician (M.D., or D.O.) including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus.
• Experience in translational clinical research in academia or the pharmaceutical industry
• A thorough knowledge of clinical medicine and science management. This entails defining critical objectives clearly and maintaining focus toward achieving business outcomes on time, on budget and with superior quality.
• An ability to communicate effectively in meetings and via written and oral presentations is essential. This includes facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Demonstrated experience leading, managing and motivating team members (e.g., internal staff and external investigators or consultants). Prior personnel management experience is a requirement.
• An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including:
  • Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
  • Understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
  • Working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies.
  • Dedication to assigned, developed projects and project goals. This includes an appreciation of the principles applied in setting and achieving corporate goals through matrixed teamwork in a compliant, regulated business setting.
  • Willingness to travel 30% of time, over weekends and ability to travel internationally.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication -Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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