My client is expanding and seeks a Senior Scientist to support preclinical development. The ideal candidate will take on the following tasks:
- Develop translational strategies to take leads from candidate selection to successful IND and BLA.
- Serve on project teams with the goal of developing novel therapeutic drugs and targets.
- Apply practical experience of immunology and immunotoxicology to gene therapies and biologics.
- Serve as SME for the design and reporting of nonclinical studies performed externally with CROs and academic partners.
- Advance understanding of immune responses associated with gene therapy in preclinical studies and how this translates to clinical studies.
- Liaise with Regulatory, CMC, Clinical, Quality Assurance, Bioanalytical Sciences and other groups.
The ideal candidate will possess the following qualities:
- MS/PhD and 5+ years of experience in human immunology and preclinical models.
- Knowledge and practical experience of immunological and molecular principles including flow cytometry and other techniques.
- Experience in coordination, organization, analysis, and documentation of nonclinical studies.
- Ability to synthesize, organize, and analyze diverse, multidisciplinary data sets.
- Experience developing a wide range of methodologies and perform advanced data analysis.
- Working knowledge of regulatory guidelines relevant to preclinical development is a plus.