Senior Clinical Scientist, GIS
Olympus Corporation of the Americas
full-time
Posted on:
Location Type: Office
Location: Westborough • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $114,467 - $160,254 per year
Job Level
Senior
About the role
- Collaborates closely with the leadership of Clinical Affairs to execute clinical strategy activities
- Oversees aspects of clinical studies in support of clinical evidence generation strategies across the GIS - Gastrointestinal Solutions Division
- Participates 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
- Responsible for writing clinical study protocols, case report forms, and study reports
- Works closely with study sites to obtain necessary approvals (EC/IRB)
- Responds critically to questions raised throughout the clinical study execution
- Provides critical input into Business Development, R&D, and product development project 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
- Translates corporate and divisional initiatives into operational plans
- Oversees execution of Investigator Initiated Trials (IIT) and Collaborative Clinical Research (CCR) initiatives
- Presents clinical study updates to internal and external stakeholders
- Supports Publication strategies
- Supports Regulatory submissions
- Facilitates 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
Requirements
- BA/BS degree in life sciences or related field
- Minimum of 8 years medical device industry experience post-degree preferably in Clinical Affairs/Operations, Medical Affairs within biotech industry
- Experience working on evidence generation strategies
- 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
- Abilty 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
- 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 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.
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**
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study protocolscase report formsstudy reportsevidence generation strategiesregulatory submissionsclinical evidence generationinvestigator initiated trialscollaborative clinical researchscientific writingproject planning
Soft skills
strategic thinkingcritical analysissynthesis of dataorganizational skillsinnovationresourcefulnessteam collaborationcommunication skillsrelationship buildingattention to detail
Certifications
BA/BS degree in life sciences