[Hiring] Clinical Research Scientist @Olympus Corporation of the Americas

Role Description

This role collaborates closely with the leadership of Clinical Affairs to assist in the development and execution of clinical strategy activities and clinical studies in support of clinical evidence generation strategies across the Gastrointestinal Solutions Division business unit. This role focuses on clinical evidence generation and trial strategy rather than laboratory experimentation, bench research, or wet-lab activities.

We are only considering candidates located in the continental United States (North America) with a preference for candidates located in the East Coast time zone.

This individual assists in the development, execution, and closeout of evidence generation activities to support product development, regulatory approval, reimbursement strategies, and overall commercialization of Olympus’s portfolio. Specifically, this individual will be responsible for:

• Writing clinical study protocols, case report forms, and study reports.
• Working closely with study sites to obtain necessary approvals (EC/IRB).
• Responding critically to questions raised throughout the clinical study execution.

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

Qualifications

• BA/BS degree in life sciences or related field; advanced degree in life sciences, medicine or related field highly preferred.
• Minimum of 5 years medical device industry experience post-degree, preferably in Clinical Affairs/Operations, Medical Affairs within biotech industry.
• Experience translating marketing and commercial needs into clinical research and evidence-generation strategies and clinical trial design.
• Experience working in a global cross-functional team (functional/matrix) environment.
• 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 the 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.
• Domestic and international travel up to 5-10%, including weekend and evening travel as needed.
• Scheduling flexibility to commit to a global weekly schedule (Tuesday – Wednesday – Thursday).

Requirements

• 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.
• Ensure clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
• Other duties as assigned.

Benefits

• 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.
• 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.