Amber Bio hiring Associate Director or Director, Nonclinical Development in San Francisco Bay Area | LinkedIn LinkedIn respects your privacy LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads ) on and off LinkedIn. Learn more in our Cookie Policy . Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at any time in your settings . Accept Reject Skip to main content LinkedIn Associate Director or Director, Nonclinical Development in Paris Expand search This button displays the currently selected search type. When expanded it provides a list of search options that will switch the search inputs to match the current selection. Jobs People Learning Clear text Clear text Clear text Clear text Clear text Sign in Join now Associate Director or Director, Nonclinical Development Amber Bio San Francisco Bay Area Apply Associate Director or Director, Nonclinical Development Amber Bio San Francisco Bay Area 1 month ago 177 applicants See who Amber Bio has hired for this role Apply Save Report this job Direct message the job poster from Amber Bio Jacob Borrajo Jacob Borrajo CEO at Amber Bio 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 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 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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Location
San Francisco Bay Area
Experience
5+ years
Total raised
$26.0M
Last stage
Seed
Investors
Jacob Borrajo
Co-founder
Basem Al-Shayeb
Co-founder
No applications, no recruiter spam. Just the intro.
A few questions to make sure this role is the right shape for you. Two minutes.
I write the intro, send it to the founder, and handle the back-and-forth.
If they’re a yes, I book the chat. You show up — that’s the whole job-hunt.