455 Mission Bay Blvd. (South) San Francisco, California 94158 | Contract
Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients.
- Participates in the design, implementation and analysis of toxicology studies working with research and development scientists.
- Responsible for monitoring and implementing toxicology strategies through contract research organizations.
- Responsibilities include outsourcing and monitoring toxicology studies, through analysis and reporting.
- Assists with regulatory submissions.
- Maintain expertise in development toxicology with focus on immune-toxicology.
- Collaborates with development teams to evaluate the safety profile of candidate molecules.
- Executes the nonclinical safety evaluation plan to support clinical development of drug candidates through monitoring CRO based toxicology studies.
- Collaborates writing regulatory filings to support clinical development.
- Works on complex problems in which analysis of situations or data requires evaluation of various factors.
- Synthesizes multiple data sources and draws general, non-obvious conclusions.
- Defines problems, develops approaches and develops experiments with sound judgment with minimum supervision.
- Coordinates activities with other team members. Writes and complex reports and protocols.
- Background in immunology and experience with immune-oncology is desired.
- Experience with GLP and CRO management is a must.
- Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought.
- Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment.
- Must be able to clearly communicate scientific information both written and oral.
- Must be able to compose sound written work.
- Must possess good oral and written communication skills.
- Ability to present technical information to both technical and non-technical audiences is required.
- Must be able to demonstrate sound judgment.
- Must be able to demonstrate problem solving capabilities.
- Strong organizational skills are required.
- Good computer skills are required.
- Working knowledge of MS word, Excel, PowerPoint is a plus.
- Experience working in an FDA regulated environment and knowledge of current GMPs and GLPs as they apply to laboratory practices are highly desired.
- Previous management skills are a plus.
- Must be willing to work as part of a team.
- Must be able to demonstrate good interpersonal skills.
- A PhD in a scientific discipline is required.
- Equivalent experience may be accepted.
- A minimum of 2 years work experience in a research and/or development environment is required.
- Post-doctoral work may serve as experience.
- Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered.