Clinical Research Scientist

About the role

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.

Responsibilities

• 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.

Requirements

• 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.
• 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.

Qualifications

• Required: BA/BS degree in life sciences or related field.
• Preferred: Advanced degree in life sciences, medicine or related field.
• Required: Minimum of 5 medical device industry experience post-degree preferably in Clinical Affairs/Operations, Medical Affairs within biotech industry.
• Required: Experience translating marketing and commercial needs into clinical research and evidence-generation strategies and clinical trial design.
• Required: 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.
• Required: Ability to think strategically, critically analyse and synthesize complicated data and scientific information.
• Required: Demonstrated scientific writing ability.
• Required: Ability to plan and organize project assignments of substantial variety and complexity.
• Required: Ability to be innovative, resourceful, and work with minimal direction.
• Required: Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Required: Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
• Required: Demonstrated ability to engage with external stakeholders; build and maintain relationships with key opinion leaders, investigators, and research staff.
• Required: Strong organizational and follow-up skills, as well as attention to detail.
• Required: Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Required: 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.

Skills

• Strategic thinking
• Scientific writing
• Project management
• Collaboration
• Communication
• Regulatory compliance

Benefits

• Competitive salaries
• Annual bonus
• 401(k) with company match
• Comprehensive medical, dental, vision coverage
• 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
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance

Pay

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.

Schedule

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.