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Olympus Corporation · 6 hours ago

Senior Clinical Scientist

Greater Boston

Full-time

Hybrid

Senior Level, Lead/Staff

$114K/yr - $160K/yr

8+ years exp

Olympus Corporation is a global medical technology company focused on advancing medical technologies and improving patient care. The Senior Clinical Scientist will collaborate with Clinical Affairs leadership to execute clinical strategies and oversee clinical studies, contributing to evidence generation for product development and regulatory approvals.

ElectronicsIndustrialManufacturingMedical DeviceProduct Design

Responsibilities

In collaboration with internal and external to MSA stakeholders, contribute to an evidence generation strategy that will drive the clinical evidence strategy for OLY business units

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

Facilitate 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

Other duties as assigned

Qualification

Clinical AffairsMedical device experienceEvidence generation strategiesScientific writingProject managementCross-functional collaborationCommunication skillsOrganizational skillsCritical thinkingTeamwork

Required

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

Ability 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