Director of Toxicology and Pharmacology
Germantown, MD
Full Time
Mid Level
Salary: $170,000 - 220,000/year
Benefits: stock options, bonus, 25 days paid leave + public holidays, fully funded health, dental, vision, 5% 401K.
RESPONSIBILITIES:
- Design and oversee conduct of non-GLP investigative or GLP toxicology studies to support our platform and therapeutic programs.
- Serve as a Study Monitor for outsourced toxicology studies. Responsibilities include protocol development, successful execution and report review. Ensure that the studies are conducted in line and adhere to appropriate guidelines and regulatory testing standards.
- Drive the identification, evaluation, selection and management of Contract Research Organizations (CROs) to ensure successful execution of studies in a timely manner.
- Collaborate on the design of internal non-GLP investigative toxicity studies in support of advancement of the platform and development compounds, as needed
- Analyze and interpret toxicology/safety pharmacology data and provide recommendations to the platform/program teams.
- Contribute to the preparation of nonclinical components for regulatory submissions
- Communicate toxicology data to Generation Bio platform and program teams and executive leadership, as needed
REQUIREMENTS:
- PhDin Toxicology or related discipline with 10+ years of opharmaceutical/biotech industry.
- Experience with rare genetic diseases and/or prior experience with gene therapy or nucleic acid therapeutics is highly desirable
- Experience with early discovery or investigative toxicology a plus
- Expert and current knowledge of global regulatory guidelines (e.g. ICH and geography-specific) and GLP standards is important
- Ability to critically evaluate written toxicology documents for overall quality and acceptability of scientific interpretation.
- Experience in developing toxicology programs to support early and late-stage drug development and in preparing regulatory filings such as INDs/CTAs, is preferable
- Effective organization skills and ability to work in a multi-tasking, collaborative and fast-paced environment
- Ability to work well in a team setting and to build strong cross-functional relationships
Apply for this position
Required*