Amber Bio · 2 months ago
Director, Nonclinical Development
San Francisco Bay Area
Full-time
Onsite
Director/Executive
8+ years expAmber Bio is a biotechnology company pioneering new gene editing modalities. They are seeking an experienced Director of Nonclinical Development to lead preclinical activities supporting their RNA editing pipeline, overseeing pharmacology, biodistribution, and toxicology studies.
BiotechnologyGeneticsPharmaceutical
Hiring Manager
Jacob Borrajo
Responsibilities
Design, oversee, and interpret preclinical studies (non-GLP and GLP), including pharmacology, biodistribution, and toxicology studies
Select, negotiate, and manage CROs and external partners
Write, review, and edit preclinical study reports and nonclinical sections of regulatory submissions
Ensure data, methods, studies, and reports meet FDA, EMA, and ICH guidelines
Define and implement the nonclinical development strategy for RNA editing programs from candidate selection through IND submission
Identify key risks, mitigation strategies, and timelines for nonclinical workstreams
Maintain up-to-date knowledge of regulatory guidance and emerging science in RNA editing, gene therapy, and AAV biology
Partner with discovery scientists to inform candidate selection strategy
Work with manufacturing and analytical teams to ensure efficient hand-offs and successful integration of data across functions
Communicate findings and recommendations clearly to project teams, leadership, and external stakeholders
Qualification
Required
PhD in Pharmacology, Toxicology, Biology, or related discipline
8-12 years of experience in preclinical development, with at least 5 years in a biotech/pharma environment
Experience in drug development for ocular and CNS indications
Demonstrated track record of designing, monitoring, and interpreting preclinical safety & efficacy studies for IND submissions
Strong understanding of FDA and ICH guidance on gene therapy
Proven success in managing CROs and vendors for GLP/non-GLP studies
Experience integrating nonclinical data into regulatory submissions
Ability to synthesize complex data sets and communicate effectively across functions
Ability to travel up to 25% of the time
Preferred
High motivation, with a strong work ethic and dedication to generating impact
Attention to detail, with the ability to extract deep insights from data
Ability to go from ideation to data in an independent fashion
Long-term personal vision with defined career goals
Team-oriented thinking
Demonstrated excellence in small team environments, including a 'no task is too small' attitude
Company
Amber Bio
Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits.
2-10 employees
H1B Sponsorship
Amber Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Early StageTotal Funding
$26M2023-08-03Seed· $26M
Leadership Team
Jacob Borrajo
Co-Founder & CEO
Recent News
2026-01-10
2026-01-10
2026-01-10
Company data provided by crunchbase