Medical Director

Position Summary
As a key member of Clinical Development team, the Medical Director will provide strategic direction and development oversight for Fractyl’s programs. S/he will lead relevant medical responsibilities, providing insight, direction and regulatory alignment. Collaborating closely with various members of cross-functional teams, s/he will directly guide the successful execution of programs against goals, staying close to the operational tasks with a hand-on approach. S/he will serve as an internal advisor and go-to resource for medical and scientific inquiries. Furthermore, the Director will develop and maintain relationships externally with the scientific community through participating in Advisory Boards, Professional Associations, Professional Meetings and Conferences, etc. S/he will successfully lead teams and manage budgets as assigned.

Primary Responsibilities
• Provide medical direction and review at various phases of clinical development;
• Lead and implement an orchestrated external stakeholder engagement program;
• Lead and implement key external stakeholder advisory activities that pertain to broad medical strategy;
• Oversee the effective execution of clinical trials, developing and maintaining investigator relationships on an ongoing basis and ensuring timely study-subject recruitment in line with study goals;
• Serve as a key team member, providing input on early stage prototype programs;
• Develop and execute animal and clinical study designs, developing the associated protocols in close collaboration with cross functional teams and leading the interpretation of related data;
• Lead clinical safety oversight in partnership with internal and external stakeholders;
• Oversee the medical review and sign off of promotional materials;
• Participate in, and provide input for, the publications strategy;
• Oversee the planning and execution of medical & clinical education programs, maintaining consistent and value-based measurements of all medical education activities;
• Provide input on confidential new business development opportunities as appropriate;
• Maintain team budgets, planning and tracking the related activities;
• Manage vendors and monitor vendor performance;
• Lead/co-lead cross-functional project teams within a matrix organizational structure;
• Bring a “can-do” spirit to work and deliver on other responsibilities as assigned.

Education or Certification Requirements
• MD degree and related active licenses & accreditation
• Board certification within a field related to metabolism a plus

Professional Work Experience
• 8+ years of successful and progressive global clinical development experience within related industries
• Experience in relevant clinical practice, research and academia
• Experience with industry regulations governing medical activities and medical regulatory processes
• 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
• Hands on experience managing projects related to the launch of products within related industries
• Experience leading and managing teams
• Experience working in small-company work environment
• Demonstrated successful program management including the ability to manage multiple tasks and priorities
• Track record of challenging oneself to enhance medical and scientific knowledge
• Full understanding of GCP and other relevant regulatory knowledge

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
• Self-motivated and the ability to work independently while working towards common team goals

Travel
• Up to 20% global travel (clinical trial sites, conferences, partner meetings, advisory boards, CRO management, etc.)

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

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