Director, * Preclinical Toxicology

Locana, Inc. is seeking a highly motivated professional to establish, lead and direct nonclinical toxicology

efforts for Locana’s pipeline of RNA-targeting genetic therapies. This individual will be involved in the design,

execution, analysis, interpretation and communication of preclinical safety studies of AAV vector-mediated

RNA modification therapeutics to provide preclinical safety profile and risk assessment to support drug

research and development. This position requires intellectual leadership and will serve as the preclinical

subject matter expert, advising management on the toxicological and immunological aspects of the project.

This individual will be an integral part of the company’s efforts to provide RNA-targeting gene therapy

treatments for a wide range of diseases.

Major Accountabilities:

• Develop overall toxicology strategy for research and development programs.
• Support safety testing of lead compounds, including introduction of new testing paradigms.
• Design, supervise, interpret, and report in vitro and in vivo preclinical toxicology IND-enabling

studies.

• Evaluate data quality and study progress on an ongoing basis, inform management of potential

issues, develop solutions and work with the team on corrective action plans.

• Participate in the management of CROs/academic sites in the conduct of in vitro/in vivo safety studies

and near-term potential to set up in-house toxicology capabilities.

• Participate in the preparation of preclinical dossiers for regulatory submissions, including authoring the

preclinical safety components of regulatory dossiers.

• Work closely with internal functional groups such and actively participate in team strategy discussions

for drug development programs.

• Serve as the subject matter expert for preclinical safety evaluations and immunological matters.

Qualifications and Education Requirements:

• 10+ years in the biotech/pharmaceutical industry with BS in Pharmacology/Science or 8+ years with

MS in Pharmacology/Science in or 6+ years with PhD in Pharmacology/Science.

• Demonstrated experience coordinating conduct of in vivo studies.
• Experience in gene therapy toxicology and animal studies.
• Successful experience writing/reviewing regulatory sections of INDs.
• In depth experience managing CROs to achieve nonclinical milestones on time and within budget.
• Comprehensive knowledge of the drug development process including cross functional integration

from POC through Phase I.

• A transparent, flexible, can-do approach to address issues innovatively and proactively to promote

teamwork and a pleasant work environment.

• Prefer experience in a small company and high growth, fast-paced environment.
• Experience with in vitro assays utilized in discovery and toxicological assessment.
• Familiar with regulatory toxicology guidelines, requirements and standards (GLP, OECD, ICH, CTD,

etc.) and able develop preclinical strategies that support clinical development.

• Ability to work both independently and collaboratively.
• Outstanding influencing, oral and written communication skills.
• Strong problem-solving and creative thinking skills.
• Ability to work both independently and collaboratively.

This position requires the ability to work in both biology laboratory and office environments.

• The level of this position will be based on the final candidate’s qualifications.

Please apply directly at careers@locanabio.com