Global Head, Clinical Research

Working Location: PENNSYLVANIA, CENTER VALLEY; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK 

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

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