Global Clinical Lead, Digital and Artificial Intelligence

7 days ago

Allentown, Pennsylvania, United States Olympus Full time

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. Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)* with company match

Comprehensive medical, dental, vision coverage effective on start date

24/7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance*

12 Paid Holidays

On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation/match programs

Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

Paid Educational Assistance

*US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? . At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . You Belong at Olympus We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development. Let's realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs

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