Scientist II/Senior Scientist Nonclinical Development at Epicrispr Biotechnologies

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Apr, 26

Salary

160000.0

Posted On

22 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Gene Therapy, Regulatory Requirements, Preclinical Experience, Cross-Functional Collaboration, CRO Management, Pharmacology, Toxicology, Bioanalytical Experience, Communication Skills, Analytical Skills, Problem-Solving Skills, Project Management, Risk Management, KOL Communication, Regulatory Guidance, Candidate Selection Strategy

Industry

Biotechnology Research

Description

Who Are We? Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate multiple genes simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs. We are looking for exceptional team members who want an active role in building a rapidly growing biotech. Position: Scientist II/Senior Scientist Nonclinical Development Location: South San Francisco, CA Reports to: VP of Therapeutics Job Summary Position Overview: Our company is seeking an experienced Nonclinical Development Scientist II/Senior Scientist with a deep understanding of gene therapy and regulatory agency requirements. The ideal candidate will have preclinical experience in the field of gene therapy and be able to lead the development of products from the research stage through to clinical trials. The role will involve working closely with cross-functional teams to ensure the successful development of gene therapy products that meet regulatory standards and effectively translate scientific discoveries into clinical practice. Reporting to the VP of Therapeutics, this role will deliver strategic and hands-on nonclinical development, working closely with Platform Development, Bioanalytical, and CMC teams. What you will accomplish 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. Qualifications 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. Bioanalytical experience is preferred Technical Requirements and Skills: 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. Compensation: The salary range for this position is $130,000 to $160,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that can provide safe and persistent control of targeted gene regulation. Our proprietary platform represents an entirely new class of therapeutics that can be leveraged to treat severe disease across numerous therapeutic areas, including complex diseases impacted by multiple genes. Epicrispr Biotechnologies provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Responsibilities

The role involves designing, overseeing, and interpreting nonclinical studies while managing CROs and external partners. The candidate will also write and review preclinical study reports and develop strategies for preclinical development.