Global Head, Clinical Research

Job Description

The Global Head of Clinical Research reports directly to the SVP Strategy & Operations and collaborates closely with the Medical & Scientific Affairs leadership to provide oversight of all aspects of clinical studies and support the development of clinical study strategies across the Endoscopic Solutions Division (ESD)/Therapeutic Solutions Division (TSD) business unit portfolios. Enables and accelerates Olympus Transform Strategy through strong business partnership and exceptional external collaborations and partnerships with key stakeholders and customers. Develops a medically and clinically competent community of practice within Olympus. Helps shape the external environment in clinical and medical sciences through participation in industry trade organizations, think-tanks, research consortiums and regulatory harmonization efforts. 

The individual is a critical member of MSA leadership and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across ESD and TSD business units, and within the broader Olympus organization, as appropriate. 
 

Job Duties

• In collaboration with Global Clinical Leads, Scientific Communication, Medical Affairs, Research & Biostatistics, Health Economics & Market Access, will build a best-in-class capability in clinical research sciences, clinical program management, biostatistics & data management, clinical operations & monitoring. 
• Responsible for Global Clinical Affairs (CA) operational and strategic activities, by ensuring effective governance, training, tracking and reporting systems. Develop effective team communication, analysis and documentation of performance activities.
• Develops medical/clinical strategic plans for the entire Olympus portfolio of products. This individual will work closely with internal (Global Business Unit Heads, Business Development, Commercial Business and R&D) and external stakeholders (KOL, professional societies, Regulatory Authorizes) with overall accountability for medical strategy and strategic execution of clinical studies regionally and globally.
• Responsible for oversight, review and approval process of all Clinical Affairs activities as they relate to Clinical Strategy, including clinical study execution, publications & communications, and scientific KOL engagement strategies while ensuring compliance with all applicable regulations.
• Develop key relationships within the Olympus organization to support the facilitation pre-clinical evidence generation to include ASTM benchtop testing, laboratory, small and large animal studies, cadaver, and ethnography studies.
• Ability to initiate and execute a wide variety of clinical investigations to create a comprehensive clinical research ecosystem for Olympus ranging from industry sponsored trials, industry or societal sponsored product registries, study groups, comparative effectiveness research, investigator-initiated studies (trials), as well as clinical research collaborations (CRCs) with academic institutions as well as large scale integrated delivery networks (IDNs) and health systems. Ensures clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
• Responsible for all aspects of Trial Management, Data Analysis (in collaboration with Research & Biostatistics) and Reporting and applicable Sustaining Activities.
• As a member of the MSA senior leadership team, takes ownership of the MSA mission, objectives, and strategy over a 3- to 5-year long term view, and is accountable to the SVP Strategy, Operations, and Centers of Excellence. Participates in strategic and operating planning activities, translating corporate and divisional initiatives into business unit operational plans.
• Responsible for continually improving Clinical Affairs’ infra-structure, including development of SOPs, best practices, and training and workshops.
• Drive a strong leadership culture, encouraging engagement and management accountability throughout all levels of the function. Attracting and hire world class talent, motivate teams, and develop leaders across cultures and geographies in anticipation of present and future needs. Drives development of “best practices” within SMV and CA, and create a quality-minded culture, with effective training and an individual sense of accountability through all levels of the function

Job Qualifications

Required:

• MA/MS degree in life sciences or related field. PhD degree in life sciences or related field.
• Minimum of 10 years of medical device and/or biopharmaceutical industry experience preferably in Clinical Affairs/Operations, Medical Affairs, or Clinical Development (preferably in multiple phases and multiple roles); with a minimum of 5 years in progressive medical affairs, clinical operations leadership roles. 
• Prior experience in establishing and managing a strategic Clinical Affairs/Operations organization.
• Direct people management experience and managing teams, globally.
• Strong business acumen; budget and forecasting experience.
• Ability to think strategically, critically analyse and synthesize complicated data and scientific information.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Experience in overseeing clinical operations’ procedural documentation requiring a strong knowledge and application of global regulations, guidelines, and standards (i.e., ICH E6 (R2), ISO 14155:2020) and good document management practices.
• Ability to think strategically, critically analyse and synthesize complicated data and scientific information.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
• Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
• Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.
• Domestic and international travel up to 20%, including weekend and evening travel as needed.

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