Director, Nonclinical Development - San Jose - Amber Bio

    Amber Bio
    Amber Bio San Jose

    17 hours ago

    Pharmaceutical / Bio-tech
    Description

    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: Director, Nonclinical Development

    Position 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 & 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
    • 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

    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.

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