Reports to: Director, Gene Therapy Research
Position Summary
Working within Fractyl's Gene Therapy Research Team, the Senior/Principal Scientist will be integral to the discovery and development of AAV-based gene therapies for the treatment and cure of diabetes, obesity, and other metabolic diseases. Successful candidates will be responsible for contributing to Fractyl's lead and pipeline programs with a primary focus on design, management, execution, analysis, and data reporting of non-GLP and GLP in vivo studies to evaluate delivery, efficacy, safety, and pharmacology of AAV-gene therapy candidates in various animal models. Achieving this goal will also require scientific oversight of assay development being conducted internally and with CROs. The successful candidate will drive programs forward and ensure timely and effective accomplishment of program goals in close collaboration with the Gene Therapy Research team, CROs, and academic collaborators.
Primary Responsibilities

• Collaborate cross-functionally and with preclinical CROs to support the planning and execution of in vivo studies
• Provide scientific/technical diligence and oversight on assay development activities for in vivo study sample analysis measuring gene therapy delivery, pharmacology, safety, and efficacy
• Coordinate logistics, manage, and monitor timely completion of downstream bioanalytic analyses
• Consolidate data across different in vivo bioanalytical workstreams toward preparation of study reports
• Contribute to identification of potential new CRO and academic collaborative partners and assist in GLP audits
• Develop timelines and milestones to ensure timely completion of deliverables internally and externally
• Contribute to in vivo discovery and early proof of concept efforts for new projects in Fractyl's pipeline
• Prepare technical reports, summaries, protocols, quantitative analysis, and presentations for experimental results.
• Manage, train, and develop junior research scientist/s.
• Bring forward essential bioanalytic assays for assessment of immunotolerability of AAV gene therapy.
• 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

• PhD in biology, molecular biology, physiology, or relevant research field
• OR a Master's degree with 10-12 years relevant industry experience

Professional Work Experience

• 5-10 years of highly relevant post-PhD experience either in an academic or industry environment
• (Preferred) Applicable experience in biotech and/or pharmaceutical industries
• (Preferred) Direct management experience of associate scientists and/or scientists

Qualifications and Skills

• Experience planning and managing small and/or large animal studies
• Experience working with preclinical and bioanalytical CROs
• Experience in development and optimization of bioanalytical assays relevant to AAV gene therapy pharmacology and safety (e.g. biodistribution, GOI RNA expression and protein quantification, ADA, nAb/Tab, ELISpot)
• Experience with molecular and cellular biology instruments and techniques, e.g., DNA/RNA/Protein purification, ddPCR and qPCR, flow cytometry, Western blotting, MSD, ELISAs, TapeStation, JESS
• (Preferred) Prior experience working in metabolic disease (T1D, T2D, obesity, NASH, etc.)
• (Preferred) Past contributions to programs that have progressed from discovery research to IND/CTA
• Experience and/or willingness to work with small and large animal models and tissues
• Track record of challenging oneself to enhance scientific and professional abilities

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

• Limited travel may be required for the role (<10%) for conference attendance and monitoring CROs.

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