Lead Scientist, In Vivo Bioanalytics for Gene Therapy

2 weeks ago

Burlington, Massachusetts, United States Fractyl Health, Inc Full time
Position Title: Lead Scientist, In Vivo Bioanalytics for Gene Therapy

Reports to: Director, Gene Therapy Research

Position Overview:

As a pivotal member of Fractyl Health's Gene Therapy Research Team, the Lead Scientist will play a crucial role in the innovation and advancement of AAV-based gene therapies aimed at addressing diabetes, obesity, and other metabolic disorders.

The ideal candidate will be tasked with supporting Fractyl's leading and pipeline initiatives, focusing primarily on the design, oversight, execution, analysis, and reporting of both non-GLP and GLP in vivo studies. These studies will assess the delivery, effectiveness, safety, and pharmacological profiles of AAV-gene therapy candidates across various animal models.

This role will also necessitate scientific leadership in the development of assays conducted both internally and in collaboration with Contract Research Organizations (CROs).


Key Responsibilities:
  • Engage in cross-functional collaboration and work closely with preclinical CROs to facilitate the planning and execution of in vivo studies.
  • Provide scientific and technical guidance on assay development for in vivo study sample analysis, focusing on gene therapy delivery, pharmacology, safety, and efficacy.
  • Oversee logistics, manage timelines, and ensure the timely completion of downstream bioanalytical analyses.
  • Aggregate data from various in vivo bioanalytical workflows to prepare comprehensive study reports.
  • Assist in identifying potential new CRO and academic partners, and support GLP audits.
  • Establish timelines and milestones to guarantee the prompt completion of internal and external deliverables.
  • Contribute to in vivo discovery and early proof-of-concept efforts for new projects within Fractyl's pipeline.
  • Draft technical reports, summaries, protocols, quantitative analyses, and presentations for experimental findings.
  • Mentor, train, and develop junior research scientists.
  • Advance essential bioanalytical assays to evaluate the immunotolerability of AAV gene therapy.

All activities must be conducted in compliance with applicable regulations and Fractyl's policies, including the timely documentation of activities and maintaining necessary training.

Bring a proactive attitude to the workplace and fulfill additional responsibilities as assigned.


Education and Certification Requirements:
  • PhD in biology, molecular biology, physiology, or a related research field.
  • Alternatively, a Master's degree with 10-12 years of relevant industry experience.

Professional Experience:
  • 5-10 years of pertinent post-PhD experience in either an academic or industry setting.
  • (Preferred) Experience in the biotech and/or pharmaceutical sectors.
  • (Preferred) Direct management experience of associate scientists and/or scientists.

Qualifications and Skills:
  • Experience in planning and managing studies involving small and/or large animals.
  • Familiarity with preclinical and bioanalytical CROs.
  • Expertise in developing and optimizing bioanalytical assays relevant to AAV gene therapy pharmacology and safety.
  • Proficiency with molecular and cellular biology techniques and instruments.
  • (Preferred) Background in metabolic diseases such as T1D, T2D, obesity, NASH, etc.
  • (Preferred) Contributions to programs that have advanced from discovery research to IND/CTA.
  • Willingness to work with small and large animal models and tissues.
  • A track record of pursuing scientific and professional growth.

Essential Attributes:
  • Proven success in dynamic, high-growth environments.
  • Demonstrated intellectual curiosity, innovation, and problem-solving skills.
  • Ability to lead projects with urgency and efficiency.
  • Hands-on experience and expertise in relevant fields.
  • Strong collaboration skills in small team settings.
  • Highly organized, detail-oriented, and committed to delivering quality results.
  • Excellent communication skills, capable of translating complex concepts into accessible documentation.
  • Exemplary professionalism and ethical standards.

Travel: Limited travel may be required for this role.

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