Careers at GABAeron

Scientist – Neurodegenerative Disease Models

We are seeking an experienced Scientist with deep expertise in neurodegenerative disease research and a strong track record of working with rodent models. The ideal candidates will have hands-on experience in characterizing both functional and pathological phenotypes and will play a key role in assessing the in vivo efficacy and therapeutic potential of candidate treatments.

This is a lab-based, highly collaborative position focused on leveraging established rodent models to evaluate treatment responses and generate robust, translatable preclinical data. The Scientist will provide leadership in study and execution, employing a range of histological, pathological, and behavioral assays, as well as electrophysiological analyses to evaluate disease phenotypes and assess treatment effects.

Key Responsibilities

• Design, execute, and troubleshoot in vivo studies in rodent models of neurodegenerative disease following iPSC-derived cell transplantation 
• Perform and refine stereotaxic surgeries related to cell transplantation and electrophysiological studies
• Conduct immunohistochemical examination of rodent brains for neuropathological characterization
• Plan, execute, and troubleshoot behavioral assays used in rodent models
• Utilize protocols for single-cell RNA analyses, including computational analysis of the data
• Manage multiple concurrent projects, ensuring high-quality, reliable, reproducible, and well-documented experimental results
• Present data effectively in internal meetings and contribute to strategic discussions around preclinical development and IND-enabling studies

Qualifications

• PhD in Neuroscience, Neuropathology, or a related discipline
• 5+ years of experience working with rodent models, preferably in neurodegenerative disease research
• Demonstrated industry experience in preclinical research studies leading to an IND is strongly preferred
• Excellent problem-solving skills, attention to detail, and ability to adapt in a fast-paced cross-functional lab environment
• Strong communication, collaboration, and presentation skills
• Proficiency with Google Suite, Microsoft applications, and relevant scientific tools

Senior Director – Regulatory Affairs

The Senior Director of Regulatory Affairs will lead the company’s regulatory strategy, providing leadership and oversight for product development to support the IND and early clinical trial application and studies. This person will serve as the company’s regulatory expert, driving the preparation and submission of regulatory filings, establishing and maintaining relationships with health authorities, and ensuring adherence to evolving standards.

The successful candidate will bring a deep expertise in regulatory science, a strong understanding of cell therapy and neuroscience programs, and an ability to guide a cross-functional team through preclinical development toward first-in-human studies.

Key Responsibilities

• Regulatory Strategy and Leadership
  • Provides strategic and scientific leadership to ensure development plans align with regulatory requirements and position programs for a successful IND submission
  • Develop and execute regulatory strategies and internal procedures to advance preclinical efficacy studies and clinical trial readiness
  • Serve as the principal regulatory liaison with the FDA, EMA, and other health authorities
• Regulatory Operations and Submissions
  • Plan, prepare, and review regulatory submissions, including INDs, CTAs, amendments, and related correspondence
  • Lead regulatory meetings, coordinate documentation, and follow up with agencies
  • Manage timelines and deliverables to ensure high-quality submissions that meet program deadlines
  • Maintain records and compliance documentation for all regulatory interactions
• Cross-Functional Collaboration
  • Partner closely with the internal and CMC teams to ensure scientific and regulatory alignment
  • Coordinate with the external CRO and collaborators, supporting cell product manufacturing and development
  • Establish internal procedures for regulatory operations, ensuring continuous process improvement and institutional readiness
• Leadership and Development
  • Provide mentorship and regulatory training to scientific staff
  • Help build a culture of compliance, transparency, and operational excellence
  • Monitor, analyze, and communicate evolving developments that may affect ongoing and future programs

Required Qualifications and Experience:

• MD or PhD, or a Master’s Degree with extensive experience
• A minimum of 8+ years in regulatory affairs with 12+ years in the biotech/pharma industry, including experience in leadership roles
• Proven experience leading successful IND and clinical trial applications
• Demonstrated success in regulatory agency interactions and meetings
• Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills
• Thorough knowledge of US and international regulations, standards, and guidance documents
• Experience in cell therapy and the neurosciences
• Ability to thrive in a dynamic, collaborative, cross-functional environment
• Proficient at creating and communicating a clear vision among team members
• Strategic mindset with the ability to integrate scientific, clinical, and regulatory perspectives