Associate Director or Director, Nonclinical Development

Responsibilities: Study Design & Oversight 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 Strategic Leadership 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 Collaboration & Communication 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

Qualifications: PhD in Pharmacology, Toxicology, Biology, or related discipline 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 Preference will be given to those who display: 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 If 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. Show more Show less Seniority level Mid-Senior level Employment type Full-time Job function Other Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Amber Bio by 2x See who you know Featured

Benefits Inferred from the description for this job Medical insurance Dental insurance Vision insurance 401(k) Get notified about new Associate Director of Development jobs in San Francisco Bay Area . 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