Global Clinical Lead, Digital and Artificial Intelligence (AI)

Job Description

The Global Clinical Lead, Digital and AI reports directly to the Global VP, Clinical Affairs and collaborates closely with the leadership of Clinical Affairs to execute clinical strategy activities and oversee aspects of clinical studies in support of clinical evidence generation strategies across the Digital and AI business unit portfolios.

This individual will lead the development, execution, and closeout of evidence generation activities to support product development, regulatory approval, reimbursement strategies, and overall commercialization of Olympus’ Digital/AI portfolio.

The individual is a critical member of Clinical Affairs strategy team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across the Digital and AI business units, and within the broader Olympus organization, as appropriate.

Job Duties

• In collaboration with internal and external to MSA stakeholders, develop and lead the execution of an evidence generation strategy for the Digital/AI business units.
• Provides critical input into Business Development, R&D, and Digital/AI business unit product development project (PDP) activities to inform decision-making on whether clinical evidence supports a product’s value proposition.
• Leads strategic and operating planning activities in partnership Clinical Operations leadership to translate corporate and divisional initiatives into operational plans.
• Design scientifically robust clinical studies (protocol and CRF development), execution (data collection, analysis, and interpretation), and closeout (final reporting).
• Oversee execution of Investigator Initiated Trials (IIT) and Collaborative Clinical Research (CCR) initiatives.
• Present clinical study updates to internal and external stakeholders; support Publication strategies.
• Support Regulatory submissions.
• Facilitate communication between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs, and investigational sites.
• Ensures clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
• As a member of the Clinical Affairs leadership team, takes ownership of the Clinical Affairs mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Global Head of Clinical Affairs.
• Develops and works to continually improve Clinical Affairs’ infrastructure, including development of SOPs, best practices, and training and workshops.
• Other duties as assigned.

Job Qualifications

Required:

• BA/BS degree in life sciences or related field.
• Minimum of 15 years medical device industry experience post-degree preferably in Clinical Affairs/Operations, Medical Affairs within biotech industry.
• Experience working on evidence generation strategies specifically on AI studies and programs.
• 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.
• Direct people management experience and managing teams.
• Strong knowledge and application of global regulations, guidelines and standards related to AI software as a medical device.
• Ability to think strategically, critically analyze and synthesize complicated data and scientific information. Demonstrated scientific writing ability.
• Ability to plan and organize project assignments of substantial variety and complexity.
• Ability to be innovative, resourceful, and work with minimal direction.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Demonstrated ability to engage with external stakeholders; build and maintain relationships with key opinion leaders, investigators, and research staff.
• Strong organizational and follow-up skills, as well as attention to detail.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Other Considerations (travel/hours availability, etc.):
• Domestic and international travel up to 15%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships.
• Scheduling flexibility to commit to a global weekly schedule (Tuesday – Wednesday – Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings.

Preferred:

• Advanced degree in life sciences, medicine or related field.
• Experience on CADe/CADx technologies in the GI region.