Head of Regulatory Developments

4 weeks ago

Sunnyvale CA, United States Amber Bio Full time

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. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn. Director, Nonclinical Development
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.
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
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
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
~ 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

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
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.

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