Associate Director or Director, Nonclinical Development - Fremont, CA - Amber Bio

    Amber Bio
    Amber Bio Fremont, CA

    1 day ago

    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. If you are interested in building a new frontier in genetic medicine, please apply via LinkedIn. Associate Director or 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.
    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
    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
    Experience in drug development for ocular and CNS indications
    Demonstrated track record of designing, monitoring, and interpreting preclinical safety & efficacy studies for IND submissions
    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
    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.
  • Work in company

    Associate Director, Nonclinical Development

    Only for registered members

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    Newark, California, United States $205,000 - $251,000 (USD) per year

    1 day ago

  • Work in company

    Associate Director, Nonclinical Development

    Only for registered members

    Ardelyx is seeking an Associate Director of Nonclinical Development to join its experienced R&D team supporting drug development programs. · Oversee the conduct of nonclinical studies to support Ardelyx programs. · ...

    Newark, CA

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  • 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 fir ...

    Fremont

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    Hayward

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  • Work in company

    Associate Director or Director, Nonclinical Development

    Only for registered members

    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 fir ...

    San Francisco

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  • 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 fir ...

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    Only for registered members

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  • Work in company

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    Only for registered members

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    Only for registered members

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  • Work in company

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    Only for registered members

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  • Work in company

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    Only for registered members

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    Only for registered members

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