Job Description

Working Location: PENNSYLVANIA, CENTER VALLEY; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people\'s lives and health, including yours? Let\'s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people\'s lives better for over 100 years.

Our Purpose is to make people\'s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity - Empathy - Agility - Unity - Long-Term View

We deliver on our purpose and our core values by staying True to Life.



Chief Medical Officer (CMO) is responsible for the leadership strategy and oversight of the OCA Medical Affairs function in the USA Canada and Latin America (OCA Geographies) to support and advance product portfolio of medical devices and ancillary products in full compliance with applicable laws and regulations and in adherence to standards of ethics and transparency. The CMO assumes the role of a key interface with OCA external partners (HCPs HCOs professional societies publications etc.) as well as internal teams (Regulatory IR/PR Marketing) and other RBCs.

Job Duties

• In collaboration with Global Clinical Leads, Scientific Communication, Medical Affairs, Research & Biostatistics, Health Economics & Market Access, will build a best-in-class capability in clinical research sciences, clinical program management, biostatistics & data management, clinical operations & monitoring.
• Responsible for Global Clinical Affairs (CA) operational and strategic activities, by ensuring effective governance, training, tracking and reporting systems. Develop effective team communication, analysis and documentation of performance activities.
• Develops medical/clinical strategic plans for the entire Olympus portfolio of products. This individual will work closely with internal (Global Business Unit Heads, Business Development, Commercial Business and R&D) and external stakeholders (KOL, professional societies, Regulatory Authorizes) with overall accountability for medical strategy and strategic execution of clinical studies regionally and globally.
• Responsible for oversight, review and approval process of all Clinical Affairs activities as they relate to Clinical Strategy, including clinical study execution, publications & communications, and scientific KOL engagement strategies while ensuring compliance with all applicable regulations.
• Develop key relationships within the Olympus organization to support the facilitation pre-clinical evidence generation to include ASTM benchtop testing, laboratory, small and large animal studies, cadaver, and ethnography studies.
• Ability to initiate and execute a wide variety of clinical investigations to create a comprehensive clinical research ecosystem for Olympus ranging from industry sponsored trials, industry or societal sponsored product registries, study groups, comparative effectiveness research, investigator-initiated studies (trials), as well as clinical research collaborations (CRCs) with academic institutions as well as large scale integrated delivery networks (IDNs) and health systems. Ensures clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
• Responsible for all aspects of Trial Management, Data Analysis (in collaboration with Research & Biostatistics) and Reporting and applicable Sustaining Activities.
• As a member of the MSA senior leadership team, takes ownership of the MSA mission, objectives, and strategy over a 3- to 5-year long term view, and is accountable to the SVP Strategy, Operations, and Centers of Excellence. Participates in strategic and operating planning activities, translating corporate and divisional initiatives into business unit operational plans.
• Responsible for continually improving Clinical Affairs\' infra-structure, including development of SOPs, best practices, and training and workshops.
• Drive a strong leadership culture, encouraging engagement and management accountability throughout all levels of the function. Attracting and hire world class talent, motivate teams, and develop leaders across cultures and geographies in anticipation of present and future needs. Drives development of \xe2\x80\x9cbest practices\xe2\x80\x9d within SMV and CA, and create a quality-minded culture, with effective training and an individual sense of accountability through all levels of the function.

Job Qualifications

Required:

• MA/MS degree in life sciences or related field
• Minimum of 10 years of medical device and/or biopharmaceutical industry experience preferably in Clinical Affairs/Operations, Medical Affairs, or Clinical Development (preferably in multiple phases and multiple roles); with a minimum of 5 years in progressive medical affairs, clinical operations leadership roles.
• Prior experience in establishing and managing a strategic Clinical Affairs/Operations organization.
• Direct people management experience and managing teams, globally.
• Strong business acumen; budget and forecasting experience.
• Experience in overseeing clinical operations\' procedural documentation requiring a strong knowledge and application of global regulations, guidelines, and standards (i.e., ICH E6 (R2), ISO 14155:2020) and good document management practices.
• 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.
• Domestic and international travel up to 20%, including weekend and evening travel as needed.

Preferred:

• Ability to think strategically, critically analyze and synthesize complicated data and scientific information.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
• Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.

#LI-Hybrid

Why join Olympus?

Here, people matter-our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• 24/7 Employee Assistance Program
• Free virtual live and on-demand wellness classes
• Work-life balance supportive culture with hybrid and remote roles
• 12 Paid Holidays
• Educational Assistance
• Parental Leave and Adoption Assistance
• Volunteering and charitable donation match programs
• Diversity & Inclusion Programs including Colleague Affinity Networks
• On-Site Child Daycare, Caf\xc3\xa9, Fitness Center**

*US Only

**Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at .

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

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 .

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let\'s realize your potential, together.

Olympus requires all US new hires to be \xe2\x80\x9cfully vaccinated\xe2\x80\x9d against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

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 ||

Olympus