Working Location: Nationwide

Workplace Flexibility: Remote

Job 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 portfolios. 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; will work closely with study sites to obtain necessary approvals (EC/IRB); and will respond critically to questions raised throughout the clinical study execution.

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 different business units, and within the broader Olympus organization, as appropriate.

Job Duties

• In collaboration with internal and external to MSA stakeholders, provides support to the execution of evidence generation strategy that will drive the clinical evidence strategy for Gastrointestinal Solutions Division business unit.
• Provides critical input into Business Development, R&D, and product development project (PDP) activities to inform decision-making on whether clinical evidence supports a product's value proposition.
• Participates in strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives into operational plans.
• Participate in clinical trial design (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.
• Ensures 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.

Job Qualifications

Required:

• BA/BS degree in life sciences or related field. Advanced degree in life sciences, medicine or related field highly preferred.
• Minimum of 5 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 and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
• 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 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, to manage effective international and cross-divisional collaboration.
• Domestic and international travel up to 5-10%, 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.

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?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position is $100,263.00 - $135,355.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

Let's realize your potential, together.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs