Clinical Scientist

About Balt

Our purpose is to improve the lives of 150,000 patients in 2026.

Our story

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting.

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.

Why Join Balt? Join a passionate team, dedicated to making a difference.

• Working at Balt means giving meaning to your work! Pride is a strong part of our identity.
• We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
• Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
• No matter the country, we take care of you.
  
  

Would you like to be part of our story? Don't hesitate, come and join us!

About This Opportunity – Clinical Scientist

The Clinical Scientist has a strong background in clinical science and experience in clinical evidence and clinical operations. The Clinical Evidence organization supports R&D, designs and analyzes clinical trials (from FIM to Pivotal trials; post-market-research, US or International) and supports the needs of clinical operations (protocol development, data management, safety reporting). This position authors and reviews documents, including manuscripts and clinical study reports and provides strategic leadership to the department.

The individual serves as a Clinical Science representative on multi-discipline teams and identifies and resolves problems that may be complex in nature. Applies clinical science principles and knowledge to guide cross-functional partners and demonstrates critical thinking and creativity in support of projects. This position will have significant interaction with internal stakeholders and will report to the Director of Clinical Evidence.

Job Responsibilities

• Leads implementation of Clinical Evidence activities.
• Writes and contributes to Clinical Evidence reporting deliverables, including Clinical Study Reports, regulatory responses, and other related documentation
• Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations.
• Analyzes results in preparation for product applications and submissions.
• Collaborates with team members and stakeholders in planning for and supporting Clinical Evidence related projects and processes.
• Supports additional clinical, regulatory, quality and engineering related deliverable as assigned.
• Authors clinical investigational plans and protocols for product approvals and expanded indications consistent with the company’s needs and priorities.
• Maintains thorough knowledge of therapy and assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
• Authors study-related documents and/or contribute content and oversight of such documents, including, but not limited to statistical analysis plans, safety plans, case report forms, clinical study reports, and informed consent forms.
• Critically analyzes data and prepares presentations for internal and external groups including but not limited to clinicians and cross-functional team members.
• Develops podium presentations and support publication strategy in close collaboration with Clinical Evidence Director and cross-functional teams and leads the execution of the publication strategy.
• Lead publications for clinical study data through coordination with investigator authors and reviews/revises abstracts and manuscripts.
• Serve as an active member of study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol and clinical study report development.
• Analyzes literature and competitive information across products and therapies within the assigned therapeutic area.
• Oversee development of statistical analysis plans and clinical safety plans.
• Support regulatory submissions for Balt products and/or respond to questions from regulatory authorities about existing submissions.
• Prepares data to be presented during meetings with FDA.
• Performs other related duties and responsibilities.
  
  

Qualification Requirements

• Master’s degree in Life Sciences or related field. MD, DO, PhD, or Pharm.D preferred
• Minimum 5 years’ experience in Industrial or Academic clinical research focused on managing clinical science/research activities.
• Documented experience in designing and reporting on clinical studies.
• Considerable experience interpreting scientific/clinical study information.
  
  

Skills:

• Considerable experience in writing clinical evidence-based documents and other documents supporting regulatory submissions.
• Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical, scientific and clinical review activities.
• Excellent communication skills
• Comprehensive knowledge of cardiovascular or neurovascular field preferred.
• Ability to work well in a project team environment.
• Works well under pressure in a dynamic, timeline-driven environment
• Demonstrated MS Office and Adobe Acrobat software skills
  
  

More information please go to www.baltgroup.com

Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases.