Reports to: Medical Affairs Lead Europe

Position Summary 

As a key member of the Clinical and Medical team, you will be responsible for providing scientific, medical, educational, research and training support for the company’s products and Medical Affairs activities within Germany. With extensive knowledge of regulatory compliance requirements and guidelines, the MSL will engage with medical and scientific experts within Germany to exchange relevant information on Fractyl’s innovative therapeutic technology. You will identify, establish, and maintain collaborative engagements with key experts and potential partners in those areas in support of Fractyl’s goals and objectives. You will develop hands-on expertise with the Revita DMR system, maintaining an expert-level knowledge of the company’s device to effectively proctor procedures. 

Primary Responsibilities 

  • Develop professional scientific relationships with medical, scientific, and key therapeutic experts; KOLs, healthcare decision makers and patient advocacy groups; and other groups as appropriate 
  • Serve as a key Medical Affairs contact to provide accurate and appropriate clinical/scientific information about Fractyl’s products, increasing the company’s visibility among stakeholders. 
  • Represent Fractyl by providing clinical support and delivering data presentations to establish Fractyl as a science-driven leader in the development and commercialization of novel therapeutics technologies. 
  • Develop and conduct assigned scientific, medical and research presentations in accordance with Fractyl’s practices, applicable laws, regulatory guidelines, and ethical standards. 
  • Using expert knowledge in Fractyl’s clinical data and study protocols to drive procedure adoption with referring physicians. 
  • Maintain an expert level of knowledge on all aspects of the Revita system and effectively train new endoscopists/nurses and proctor procedures, inclusive of the device set up and break down. Share learnings and observations of procedural cases with the Medical Affairs team for incorporation and improvement of programs, complying with related privacy laws and regulatory requirements. 
  • Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
  • Bring a “can do” spirit to the team and deliver on other responsibilities as assigned.  

Education or Certification Requirements 

  • Advanced scientific or clinical degree. Doctorate degree (PhamrD, MD, PhD, etc.) preferred. 
  • Certification in regulatory compliance a plus. 

Professional Work Experience 

  • 5+ years direct experience in Medical Science Liaison and other relevant roles within the field. 
  • Preferred work experience in hospital setting with Gastroenterology or Endoscopy.  
  • Ability to travel on short notice.
  • Experience in biotech, pharmaceutical and/or medical device industries preferred.  
  • Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).  

Qualifications and Skills 

  • Successful track record of strategic planning, and effective and timely execution of the same. 
  • High level of understanding of compliance requirements within the regulated biotechnology environment. 
  • Clear understanding of current healthcare systems and practices, as well as clinical decision making. 
  • Ability to identify unmet medical, educational, and research needs within the regional medical community. 
  • Ability to interpret scientific data, translating these to meet educational and research needs for scientific and non-scientific audiences. 
  • Superb communication and presentation skills. 
  • Knowledge of clinical setting and have previous experience navigating in a hospital setting. 
  • Knowledge and skill related to medical device product demonstration. 
  • Proficient in computer applications including Microsoft Word, Excel, and PowerPoint. 
  • Other device-related skills:
    • Ability to lift 10lb (4.5kg) objects and wheel medical device (approximately 400lb/180kg) within medical facilities.
    • Ability to follow and carry out detailed technical instructions and AV equipment.
    • Ability to maintain detailed reports and test logs.
    • Experience with basic electronic and hydraulic systems a plus. 
  • Flexible, available for case coverage and open to support when called upon. 
  • Build relationships and work effectively with physicians, nurses, and other medical professionals, as well with all functions and levels within the hospital and business organization. 
  • Ability to work with a high degree of independence.  
  • Manages expenses within financial budget. 
  • Ability to assist the European team also outside of Germany when necessary.

Other Essentials and Key Success Factors

  • Successful track record of working in high-growth and dynamic organizations. 
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit. 
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well. 
  • Evidence of "hands-on" experience and expertise.
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highly organized and detail oriented with a passion to deliver quality results 
  • Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation. 
  • Highest levels of professionalism, confidence, personal values, and ethical standards. 

Travel 

This position requires up to 75% travel. 

The description and requirements outlined above are general; additional requirements may apply. 

 

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