Company Name:-
Olympus Corporation of the Americas

Job Location:-
Center Valley, PA 18034

Job Summary:-
Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day.

Let’s inspire healthier lives, together.

Job Description
The Global Head of Clinical Affairs reports directly to the Global Head of Medical and Clinical Affairs (MCA) and collaborates closely with the leadership of the two other functions within MCA – Medical Affairs and Operations Center of Excellence – to run all aspects of clinical studies in support of clinical evidence generation strategies across the Endoscopic Solutions Division (ESD)/Therapeutic Solutions Division (TSD) business unit portfolios.

The individual is a critical member of MCA 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 the Global Head and Global Leads of Medical Affairs, the Global Head of Operations Center of Excellence, and the Global Head of Health Economics & Market Access, conceives, develops, and implements clinical study strategies to support ESD and TSD product development programs.

Responsible for all aspects of Trial Management, Data Analysis and Reporting (with Operations Center of Excellence), and Sustaining Activities.

Provides critical input into Business Development, R&D, and ESD/TSD Product Development Project activities to inform decision-making on whether clinical evidence supports a product’s value proposition.

In situations entailing substantial clinical risk, advances reasonable mitigation strategies, which may involve future clinical studies.

Participates in strategic and operating planning activities in partnership with the Global Head of MCA, Global Head of Medical Affairs, and the Global Head of Operations Clinical Center of Excellence in translating corporate and divisional initiatives into operational plans.

Develops an outsourcing strategy to employ Contract Research Organizations (CROs), or other external vendors, in clinical studies and ensures management and oversight of the vendor(s).

Establishes and oversees activities to ensure r

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