Preclinical Study Director

About Precision NanoSystems Inc. (PNI)

Precision NanoSystems Inc. (“PNI”) is a manufacturer of instruments, kits and reagents in the global nanomedicine market providing tools for drug development and cell-specific delivery to study, diagnose and treat disease. PNI’s NanoAssemblr family of instruments allow scientists to rapidly develop novel nanomedicine drug candidates for pre-clinical testing. PNI’s NanoAssemblr Scale-up platform enables the translation of these drug candidates to clinical testing and eventually to commercial use. PNI’s NanoAssemblr™ Transfection Reagents use nanomedicine technology to deliver genetic materials in primary cells vitro and in vivo, enabling disease researchers to easily study gene function in high-value models of disease. PNI sells its products to leading pharmaceutical and biotechnology companies, and leading academic institutions in over 20 countries worldwide.  Please find more information at http://www.precisionnanosystems.com/.

Position Summary

The individual will utilize his/her highly specialized knowledge and experience for designing preclinical study protocols and engaging with various collaborators/CRO organizations.  The individual will contribute to brainstorming with colleagues and other experts and evaluate relevant animal study models for validating the concepts and therapeutic targets. The individual is expected to manage multiple projects, work well with a cross-disciplinary team of Scientists (synthetic chemists, molecular biologists, immunologists, formulation scientists), Process Development Engineers/scientists, Product Managers, Project Managers, Scientific Liaisons and Senior Leadership. The individual must be a team player who thrives in a dynamic environment with multiple tasks and aggressive deadlines and contributes to the aggressive R&D goals. The individual must have a great positive mind set and flexibility and tolerance to adapt to changes. This will be a non-bench position contributing to the success of R&D programs in Precision NanoSystems.

Areas of Responsibility

• Responsible for the write up of Investigator’s Brochure, ensuring validity of the data reported.
• Enable pre-clinical studies including PK, Biodistribution and safety toxicology studies for multiple nanoparticle application development and technology development projects accelerating PNI platform technology (Reagent platform & Instrument platform) to support PNI business/product/partnership needs.
• Develop research/project plan, budget, study protocols, and reports as needed for in vitro and in vivo pharmacology projects.
• Help collate reports required for Investigator’s Brochure and supporting reports on pre-clinical and non-clinical studies.
• Responsible for designing animal studies, study protocols and managing the pre-clinical studies with collaborators or CROs as needed.
• Contribute to establishing novel technologies in-house.
• Collaborate with various researchers to accelerate next generation genetic medicine: vaccines, cell & gene therapy, and gene editing.
• Successful conduct of preclinical studies for therapeutic vaccine development, cell & gene therapy, and gene editing.
• Help build strategy for pharmacology data package facilitating advancement of vaccine, cell & gene therapy, gene editing candidates
  Independently manage research collaboration projects; Direct/Advise colleagues on animal study requirements.
• Data management of raw data, author reports and help teams with data-driven decision making.
• Coordinate timely delivery of projects including arranging shipping and receiving of samples working with scientists and with shipping and receiving team.
• Work with Sr. leadership team and project manager/s for the approval of POs.
• Contribute to intellectual property documents, draft patent applications, evaluate prior art, and respond to patent office actions, as required.
• Collaborate with internal teams to ensure successful project completion including providing support to Product Development, Manufacturing, and Operations.
• Support all technical documentation related to projects and product development.
• Provides technical support and training to PNI staff and customers (product use, protocols).
• Maintain/establish policies and procedures, objectives, quality assurance programs for scientific data accuracy.
• Act as scientific ambassador for the company, make external presentations, publish abstracts and articles and identify collaborations.
• May be required to perform other related duties as required and/or assigned.

Qualifications and Experience

• PhD in Biochemistry, Pharmaceutical Sciences, Pharmacology, Immunology or a related field in life sciences discipline.
• Demonstrated leadership in the conduct of taking programs to clinic.
• Individual is a subject matter expert in the conduct of pre-clinical studies, safety toxicology studies.
• Demonstrated experience in regulatory submissions.
• Demonstrated experience in managing CROs, and programs with aggressive goals.
• Demonstrated Project/program management skills.
• Excellent documentation and organizational skills.
• Demonstrated ability to work in multi-disciplinary, multi-cultural teams.
• Proven ability to apply critical and analytical thinking.

PNI provides a competitive compensation and benefits package with excellent opportunities for personal growth.

Only candidates selected for an interview will be contacted. Posting valid until filled. No solicitors please.

Precision NanoSystems, Inc. is an equal opportunity employer.