Job Description

Job Duties

• Provide deep expertise, insights, as well as scientific and clinical leadership to IP strategy and strategic decision making while maintaining a sharp focus on patient safety throughout the product lifecycle, including new product development processes, R&D engineering, risk management, clinical trials, post-market safety surveillance, health hazard assessments and field corrective actions.
• Serve as the single point of contact for the US Centers of Disease Control, European Centers for Prevention & Disease Control, notified bodies, regulatory agencies, and public health authorities worldwide.
• Create and chair the Infection Control Committee and IP Surveillance Team
• Serve as the Infection Prevention Medical Leader representative at key business unit level management review meetings, staff meetings, and global meetings.
• Collaborate with the Chief Medical Safety Officer, Chief Medical Officer, and other senior leaders within Medical and Scientific Affairs to share best practices and ensure consistent patient safety for all infection prevention matters.
• Take responsibility for all IP benefit/risk assessments for Health Hazard Assessment and Field Corrective Actions.
• Serve as an internal IP subject matter expert and definitive resource to coordinate global IP responses to critical issues.
• Interact with executive management concerning significant safety issues involving IP.
• Encourage ethical decision-making, innovative and strategic thinking on IP medical/clinical/scientific/engineering topics.
• Develop processes and key performance indicators to continuously improve IP effectiveness and impact.
• Champion effective change management to enhance organizational IP capabilities.
• Engage with external organizations, key opinion leaders, and consultants/advisors.
• Provide infection prevention input to the design of clinical trials, signal detection and management activities, post authorization studies, risk minimization, and effective global communications.
• Contribute to safety and IP topics for benefit/risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory sub-committees.
• Perform post-marketing surveillance and regulatory reporting, a
• Guide contract research organizations operation and any consulting/contractor support.
• Lead and manage a reprocessing validation research and testing laboratory with state of art Good Laboratory Practices (GLP)
• Work within and actively promote Olympus’ Core mission, corporate strategies, policies, procedures, and Code of Conduct

Job Qualifications

• Advanced post-baccalaureate degree relevant to Infection Prevention required (MD, MD Ph D preferred, Ph D, DNP, MS, MPH, MHA or equivalent master’s level degrees will be considered with extensive experience
• Physician candidates: Post-graduate training and board certification in infectious diseases (American Board of Internal Medicine in the US, or regional equivalent globally).
• Minimum of 10 years of relevant clinical infectious disease or infection prevention experience with patient safety, including hospitals, academia, health systems, medical device and/or pharmaceutical manufacturers.
• Domestic and international travel 20-30%, including weekend and evening travel as needed.

• Certification in Infection Control (CIC), by the Certification Board of Infection Control and Epidemiology or equivalent type organization based upon global location is preferred.
• Previous work experience in presenting to, collaborating, or working from within global Public Health Agencies (World Health Organization, US Public Health Service Commissioned Corps, US Center for Disease Control - CDC, European Centre for Disease Prevention and Control -ECDC, US Food & Drug Administration – FDA, or equivalent), and/or Country, Regional, State, or Local Public Health Departments is preferred.
• Demonstrated leadership in a large-scale clinical setting or has previously led a team of clinical professionals focusing on infection prevention in a health system (integrated delivery network), is preferred.
• Relevant experience managing or supervising a high complexity reprocessing research & testing validation laboratory with experience and practical knowledge of methods and techniques pertaining to manual cleaning, high level disinfection and sterilization of endoscopes and surgical devices using GLP is highly preferred.