Scientist II/Senior Scientist Nonclinical Development jobs in United States
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Epicrispr Biotechnologies · 17 hours ago

Scientist II/Senior Scientist Nonclinical Development

Epicrispr Biotechnologies is a clinical stage biotech company focused on advancing gene regulation technology. They are seeking an experienced Nonclinical Development Scientist II/Senior Scientist to lead product development from research to clinical trials, ensuring compliance with regulatory standards and collaborating with cross-functional teams.

BiotechnologyHealth Care
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H1B Sponsor Likelynote

Responsibilities

Design, oversee, perform and interpret nonclinical studies (non-GLP and GLP), including proof-of-concepts, pharmacology, biodistribution, and toxicology studies within established timelines
Manage CROs and external partners
Write, review, and edit preclinical study reports and nonclinical sections of regulatory submissions
Partner with platform development scientists to inform candidate selection strategy
Develop PD biomarker strategy across programs and work closely with bioanalytical scientists to ensure efficient hands-off
Maintain up-to-date knowledge of regulatory guidance
Communicate effectively with Key Opinion Leader (KOLs) to maintain up to date understanding of the literature
Develop strategies for preclinical development, including the identification and management of risks and opportunities

Qualification

Gene therapyRegulatory agency experiencePharmacologyBioanalytical experienceCRISPR technologiesAnalytical skillsCommunication skillsProblem-solving skills

Required

Ph.D. or equivalent in medicinal chemistry, pharmacology, or related discipline, with a minimum of 5 years of related experience in biotechnology or pharmaceutical industry
Demonstrated experience working with regulatory agencies, including leading interactions with FDA, EMA, and/or other relevant agencies
Strong preclinical experience in gene therapy
Demonstrated ability to work with CRO and to collaborate with cross-functional teams and external partners, including regulatory agencies, academic institutions, and biotech companies
Understanding of gene therapy and CRISPR based technologies
Strong communication skills, with the ability to effectively present scientific data and communicate complex scientific concepts to a wide range of stakeholders
Strong analytical and problem-solving skills, with the ability to effectively identify and address complex scientific and regulatory issues
Ability to work in a fast-paced environment, manage multiple projects, and meet deadlines

Preferred

Bioanalytical experience is preferred

Company

Epicrispr Biotechnologies

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Epic Bio's strength is a relentless focus on ushering in a new era of gene regulation.

H1B Sponsorship

Epicrispr Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2023 (1)

Funding

Current Stage
Growth Stage
Total Funding
$123M
Key Investors
Ally Bridge Group
2025-03-26Series B· $68M
2022-07-12Series A· $55M

Leadership Team

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Amber Salzman
CEO
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Weston Miller
Chief Medical Officer
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Company data provided by crunchbase