Reports to: Head of Clinical Operations
Position Summary
The Medical Monitor is responsible for medical oversight of our clinical trials and authoring/coordinating the review of complex clinical and scientific documents supporting the Medical Affairs, Clinical Development, Regulatory, and Clinical Operations teams. S/he supports the Fractyl DMR (Duodenal Mucosal Resurfacing) program for the treatment of metabolic diseases by reviewing and/or generating key study documents (such as medical monitoring and safety management plans, treatment manuals, etc), assessing and interpreting safety data, and contributing to investigator, other site staff and clinical study team training. The Medical Monitor applies scientific knowledge, analytical skills, and technical writing skills to all assignments, producing high quality and timely deliverables while ensuring scientific consistency between related documents or studies in clinical programs.
Primary Responsibilities

• Work as primary Medical Monitor for assigned clinical trials and advise on trial related medical questions or problems during the conduct of the trial.
• Develop and/or review medical monitoring and safety plans for awarded studies.
• Provide final review and approval of safety narrative including company comments, analysis of similar events and participate in safety trending analysis.
• Work in conjunction with the safety team to review safety sections of charters, plans and reports for CEC, DSMB, steering committees, etc.
• Provide support for safety sections of the study regulatory required annual reports.
• Conduct literature reviews for any regulatory submissions.
• Consult with internal and external stakeholders and experts to assist in the development and assisting in the design and conduct of clinical trials including the drafting of protocols and amendments.
• Work closely with the clinical team and develop and/or edit clinical documents including Investigator Brochures, master Informed Consent Form and other related documents
• Work with the regulatory team and author and/or contribute to regulatory submissions, including, but not limited to, briefing documents, safety summaries, IDE/IDE supplements, PMAs.
• 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 work and deliver on other responsibilities as assigned.

Education or Certification Requirements

• MD or equivalent required.

Professional Work Experience

• Minimum of 5 years direct experience in the medical device industry, preferably in a medical monitoring role, required.
• Applicable 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

• Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
• Demonstrated ability to interpret and organize clinical and scientific data.
• Experience in type 2 diabetes and/or metabolic disorders and/or medical devices highly preferred
• Experience using electronic documentation management system preferred
• Strong interpersonal and communication (written and verbal) skills.
• Strong patient focus.
• Ability to work independently or with a team delivering multiple projects successfully with high quality.

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 may require up to 25% travel.
The description and requirements outlined above are general; additional requirements may apply.