Senior Global Clinical Lead, Digital and AI

Job Description

The Senior Global Clinical Lead, Digital and AI is a strategic leader within the Clinical Research leadership team, reporting directly to the Global VP, Clinical Research. This role is responsible for shaping and executing the clinical strategy across Olympus’ Digital and AI business unit portfolios, ensuring alignment with global regulatory trends, market access priorities, and innovation goals.

In addition to leading evidence generation for product development, regulatory approval, and reimbursement, this role serves as a clinical thought leader, translating complex global insights into actionable strategies that accelerate commercialization and adoption.

The Global Clinical Lead will also support partnership and business development opportunities, contribute to the integration of acquired businesses within the Olympus framework, and establish strong working relationships with internal and external stakeholders. As a critical member of the Clinical Affairs strategy team, they will collaborate across MSA, the Digital and AI business units, and the broader Olympus organization to ensure alignment and impact.

Job Duties

• In collaboration with internal and external to MSA stakeholders, develop and lead the execution of evidence generation strategies for the Digital/AI business units.
• Drive cross-functional alignment between R&D, Regulatory, Medical Affairs, and Market Access teams.
• Anticipate and respond to emerging regulatory frameworks and payer expectations for AI-enabled technologies.
• Champion Olympus’ clinical credibility in external engagements, including KOL partnerships, advisory boards, and global conferences.
• Ensure clinical strategy supports differentiated value propositions and real-world impact across diverse healthcare systems.
• Provide expert clinical insights to inform the effective development of the digital strategy through internal and external engagements while providing continuous input to ensure that the strategy remains clearly defined and consistent with business objectives.
• Conceive, develop, and implement the most appropriate global AI clinical research strategy , study design, and operational execution of industry sponsored clinical investigations (guidance, site selection, contracting, investigator training, IRB submissions, enrollment case monitoring & reporting, safety monitoring, risk management, closure, summation for publication, and best practice sharing). 
• Support partnership and business development initiatives, contribute to the integration of acquired businesses within the Olympus framework, and establish strong working relationships with internal and external stakeholders. 
• Lead 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 including governance of IIT review committees and funding approvals. 
• Present clinical study updates to internal and external stakeholders; support Publication strategies to amplify scientific presence at conferences and strengthen market engagement. 
• Continuously monitor and interpret evolving global clinical and regulatory landscapes, as well as emerging industry guidance documents and standards for AI products, translating insights into actionable clinical strategies. 
• Facilitate communication between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs, and investigational sites. 
• Ensure 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 Research leadership team, take ownership of the Medical and Scientific Affairs mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Global Head of Clinical Research. 
• Develop and works to continually improve Clinical Research’s infrastructure, including development of SOPs, best practices, and training and workshops. 
• Other duties as assigned.

Job Qualifications

Required:

• MS degree in software or computer engineering, AI information systems.
• Minimum of 15 years medical device industry experience post-degree in Clinical Affairs/Operations or Medical Affairs within biotech industry.
• Minimum of 4 years of direct experience leading the development of evidence generation strategies for AI products. Highly preferred: Experience on CADe/CADx technologies in the GI region.
• Exhibited success in MedTech product development and ability to bring strategic insights to commercialization plans in the digital therapeutics area.
• Persuasive consulting, facilitation, and communication skills bridging between medical/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.
• Strong knowledge and application of global regulations, guidelines and standards related to AI software as a medical device.
• Ability to think strategically, critically analyse 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.
• 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:

• PhD in life sciences or related field