Introduction

phenox GmbH is a specialized manufacturer of Class III medical devices for the treatment of neurovascular diseases, which are developed, manufactured and distributed. Our innovative technologies and solutions are used by neuroradiologists worldwide to treat strokes and aneurysms. We offer a growing portfolio of innovative treatment options - including long-established technologies.

To enlarge our Clinical Regulatory Affairs Team we are looking as soon as possible for a

Clinical Scientist (m/f/d)

Tasks

• Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company’s research interest.
• Give insights into clinical data sets and evidence for our company’s products to internal stakeholders.
• Assess clinical study ideas and initiatives as well as act as process owner for the respective internal approval process.
• Identify scientific projects and data analysis (together with internal and external stakeholders) to address unmet and unanswered medical research questions of the scientific community.
• Keep record of clinical initiatives, grants and data collections in the field.
• Define data endpoints and sample sizes (together with clinical evaluation team and support of biostatistics) for data collections, studies and clinical initiatives.
• Author and review study synopses and clinical trial protocols, regulatory documents, and study-related publications for clinical initiatives and grants.
• Interpret and analyze clinical data for clinical evaluations and scientific projects, working closely with clinical evaluation team and biostatistics to ensure robust scientific conclusions.
• Support regulatory submissions, post market surveillance and scientific projects, by working on and presenting scientific evidence to internal and external stakeholders.
• Engage with Key Opinion Leaders (KOLs) and physicians who lead IITs (investigator initiated trials) and/or work on scientific projects, fostering strong scientific collaborations.
• Train the clinical team on clinical trends and news.
• Stay informed on evolving clinical trends, competitor data, and regulatory updates to refine our clinical strategies.

Profile

• Master’s degree in biostatistics, biology, chemistry, or a comparable field of study
• PhD preferred, alternatively several years’ experience in the medical device industry and/or neurovascular therapeutic area
• Several years’ experience in clinical and scientific research (especially in study designs and scientific research questions)
• Data analysis and medical writing experiences
• Experience in statistical analysis and in the medical device industry is a plus
• Fluent business German and English
• Work independently and be a great team player
• Strong quality attitude; comfortable in working with other departments of the company (e.g., Quality management, R&D, Marketing)
• Confident handling of literature management tools (EndNote), databases for literature and Microsoft Office (Word, Excel, PowerPoint, Outlook, Visio etc.)
• Willingness to Travel (>30%)

We offer

• an international & dynamic team
• flexible working environment
• a comprehensive on-boarding
• possibility to evolve within the team
• a fair and motivating remuneration system
• pension scheme
• Company events/company celebrations
• flat rate for drinks
• JobRad

Further information

Does this appeal to you? Then please send your complete documents, including the earliest possible starting date and your salary expectations.

Apply