Olympus is looking to shape and execute the clinical strategy across its Digital and AI business unit portfolios, ensuring alignment with global regulatory trends, market access priorities, and innovation goals.
Requirements
- 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.
- 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.
Responsibilities
- 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.
- Conceive, develop, and implement the most appropriate global AI clinical research strategy , study design, and operational execution of industry sponsored clinical investigations.
- Design scientifically robust clinical studies (protocol and CRF development), execution (data collection, analysis, and interpretation), and closeout (final reporting).
Other
- 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.
- 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 verbal and written communications with ability to effectively communicate at multiple levels in the organization.
