Research & Development Manager, Gene Therapy and Translational Research

Company: AGTC
Location: Gainesville
Posted on: February 15, 2020

Job Description:

Mission The Scientist, Gene Therapy and Translational Research, will support in vivo pharmacology studies and promoter, capsid selection and target validation research. The in-vivo studies include preclinical research, IND enabling animal studies and support for clinical trials, such as biomarker analysis. The therapeutic areas that will be supported include ophthalmology, otology and CNS. The Scientist will work with the Senior Director, In Vivo Pharmacology and Toxicology to set specific project goals and develop detailed timelines to ensure the translation of these goals into achievable tasks. Reporting Relationship The Scientist, Gene Therapy and Translational Research will report to the Senior Director, In Vivo Pharmacology/Toxicology One or more Research Associates may report directly to the Scientist, Gene Therapy and Translational Research. Essential Duties and Responsibilities Integrate into the company, obtain and understand project-related scientific background knowledge. Effectively coordinate activities with Senior Director, In Vivo Pharmacology and Toxicology between Cambridge and Alachua teams, to achieve maximal alignment and efficiencies for study initiation and conduct at CROs. Participate in the identification and evaluation of the most appropriate cross-species animal models for existing and novel targets within AGTC focus. Assist in reviewing study design, outcome measures, data & statistical evaluation for in vivo translational studies. Identify new research directions (including new targets, methodologies, in vitro testing and other research opportunities). Design, develop and execute research projects, independently and as part of a team Review and understand experimental readouts and technologies deployed (e.g. retinal imaging, functional assessments, immunohistochemistry, routes of vector administration). Assist in IND enabling studies such as toxicology, pharmacokinetics and biodistribution studies for AAV constructs, including study design/protocol, and study report reviewing. Assist in the support for clinical trials, develop understanding of regulatory requirements and provide scientific and translational support to meet clinical trial deadlines and data packages Maintain up-to-date training and thorough knowledge of SOPs and GLP procedures. Adhere to the best practices of research, data management and archiving, observance, compliance, and updating of AGTC's Safety and Quality manual. Report scientific results at relevant meetings and submit manuscripts for publication. Educational Qualifications PhD with post-training experience at least 3 years directing and monitoring translational research studies. Good understanding of Toxicology/Pharmacology. Additional Qualifications Experience in biopharmaceutical drug discovery, managing the preclinical development of new biological therapeutics or pharmaceutical products preferred. Experience in ophthalmology and neuroscience preferred. Experience and detailed knowledge of gene therapy strongly preferred Comprehensive theoretical and technical understanding of a wide range of in vivo approaches and technologies. Familiarity with the range of IT software programs typically utilized in a biotech environment. Must be highly organized and analytical with strong problem-solving skills. Must be committed to working in a collaborative, team-based culture and be comfortable with giving and receiving feedback. Required to communicate clearly and effectively - written and oral. Supervisory Responsibilities Previous management or supervisory experience required Measures of Performance Subsequent Performance Reviews will be conducted annually within 60 days of the Company's fiscal year end. One-on-one meetings with the Senior Director will be conducted weekly for the review of work plans and data analysis.

Keywords: AGTC, Gainesville , Research & Development Manager, Gene Therapy and Translational Research, Other , Gainesville, Florida