Global Head, Infection Prevention

Job Description

The Infection Prevention Leader (IPL) is an experienced professional possessing deep experiential knowledge spanning all aspects of Infection Prevention (IP) and is responsible for providing holistic leadership for all IP functions across the product lifecycle to ensure that patient safety is a top priority. Serving as a single point of accountability for the design, execution, monitoring, delivery, and reporting of all IP activities for Olympus, the IPL will synergize independent successes of the Infection Prevention Center of Excellence (IPCOE) and Infection Prevention & Control (IPC). Fundamental competencies for this role include: 1.) Infection Prevention disease state, procedural, clinical, and technological market knowledge & experience, 2.) Comprehensive mastery of clinical infection prevention & control proficiencies (e.g., infection surveillance team, infection control committee, microbiological liaison, data analytics, epidemiological investigative principles, medical device/technology product evaluation, performance improvement, corrective action preventive action, root cause analysis, and risk management activities), from ideation to obsolescence across the product lifecycle, 3.) Capabilities in clinical integration of current and future infection prevention diagnostic/therapeutic devices & technologies to improve equitable access to care while delivering meaningful clinical and economic outcomes.  

The IPL will take charge of a highly matrixed environment to architect Olympus’ infection prevention global strategy encompassing all therapeutic areas and IP activities from an operational perspective. Matrixed relationships within Olympus will include colleagues from Quality Assurance, Regulatory Affairs, IP R&D teams, and the Infection Prevention Business Unit. The IPL will contribute decisively to new product development, design controls, risk management plans and reports, periodic safety updates and clinical sections of product labels.

This role requires the management proficiencies and leadership competencies to demonstrably lead external stakeholders through influence while simultaneously demonstrating proficiencies in scientific engagement via peer-to-peer consultations with governmental officers, physicians, payors, professional societies, patient advocacy groups, as well as health system and integrated delivery networks worldwide. The successful candidate will bring a combination of strategic mindset, strong operational involvement (“hands on mentality”), together with the personality traits of being a team player, humble and inquisitive, along with servant leadership skills.

In addition to supporting all Olympus IP activities, the IPL will design, develop, and deploy program level activities including authoring/reviewing infection prevention safety and efficacy summaries, clinical white papers, and scientific publications, coordinating thought leadership with outside experts, scientific societies, as well as global public health agencies, notified bodies, competent authorities, and Non-Governmental Organizations. In addition to work on IP specific activities the IPL will participate in standing committees, review post market surveillance trends, perform due diligence reviews, and consult to new business development on emerging market opportunities as well as contribute to the target product profile for new product development.

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

Required:

• Advanced post-baccalaureate degree relevant to Infection Prevention required (MD, MD PhD preferred, PhD, 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.

Preferred:

• 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.