Associate Director or Director, Nonclinical Development

Amber Bio is a biotechnology company pioneering new gene editing modalities using multi-kilobase edits to reach previously undruggable patient populations. Founded by pioneers in the CRISPR field from leading institutions for gene editing research, the company is developing a first-of-its-kind RNA editing platform that can correct thousands of bases at once, thereby correcting genetic mutations safely and reversibly. Multiple openings are available on a rapidly growing team. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn.Job Description: Associate Director or Director, Nonclinical DevelopmentPosition Overview:We are seeking an experienced and highly motivated Director of Nonclinical Development to lead preclinical activities supporting our RNA editing pipeline. The successful candidate will design and oversee nonclinical pharmacology, biodistribution, and toxicology studies, ensuring timely and high-quality execution to support IND submissions. Reporting into the VP of Development, the candidate will provide both strategic leadership and hands-on management in a fast-paced startup environment, partnering closely with discovery, analytical, and manufacturing teams.Key Responsibilities:Study Design & OversightDesign, oversee, and interpret preclinical studies (non-GLP and GLP), including pharmacology, biodistribution, and toxicology studiesSelect, negotiate, and manage CROs and external partnersWrite, review, and edit preclinical study reports and nonclinical sections of regulatory submissionsEnsure data, methods, studies, and reports meet FDA, EMA, and ICH guidelinesStrategic LeadershipDefine and implement the nonclinical development strategy for RNA editing programs from candidate selection through IND submissionIdentify key risks, mitigation strategies, and timelines for nonclinical workstreamsMaintain up-to-date knowledge of regulatory guidance and emerging science in RNA editing, gene therapy, and AAV biologyCollaboration & CommunicationPartner with discovery scientists to inform candidate selection strategyWork with manufacturing and analytical teams to ensure efficient hand-offs and successful integration of data across functionsCommunicate findings and recommendations clearly to project teams, leadership, and external stakeholdersQualifications:PhD in Pharmacology, Toxicology, Biology, or related disciplineAt least 5 years in a biotech/pharma environmentExperience in drug development for ocular and CNS indicationsDemonstrated track record of designing, monitoring, and interpreting preclinical safety & efficacy studies for IND submissionsStrong understanding of FDA and ICH guidance on gene therapyProven success in managing CROs and vendors for GLP/non-GLP studiesExperience integrating nonclinical data into regulatory submissionsAbility to synthesize complex data sets and communicate effectively across functionsAbility to travel up to 25% of the timePreference will be given to those who display:High motivation, with a strong work ethic and dedication to generating impactAttention to detail, with the ability to extract deep insights from dataAbility to go from ideation to data in an independent fashionLong-term personal vision with defined career goalsTeam-oriented thinkingDemonstrated excellence in small team environments, including a "no task is too small" attitudeIf you have a passion for advancing gene editing technologies and desire to be part of a pioneering biotech company, we encourage you to apply and join our ambitious team.Please apply directly through LinkedIn.Amber Bio is an equal-opportunity employer and encourages applications from candidates of diverse backgrounds. We value diversity and are committed to creating an inclusive and supportive work environment for all employees.