Pave Talent is hiring a full time, direct hire TRANSLATIONAL SCIENTIST for a rapidly growing pre-IPO biotech in San Diego. Our client develops precision medicine combination-products (drugs & devices) to access, diagnose, treat & deliver drugs to the GI Tract. The Translational Scientist will support early drug discovery, preclinical research, and clinical trial development. This role will involve conducting high throughput functional genomic/proteomic screens, cell-based assay & immunoassay development, NGS sequencing, drug product formulation development, and animal pharmacology/disease model development.

The Translational Scientist will play a key role to help design, execute, ensure scientific management and provide supervision of pre-clinical studies, draft study reports, and document for regulatory filing.

KEY QUALIFICATIONS:

• Ph.D. or Master's Degree related to Translational Research or Pharmacology
• Pharma Industry or CRO experience highly desired
• Previous experience in Pre-Clinical and/or Drug Development required,
• Ability to review and identify key strengths and weaknesses of the study protocol(s).
• Able to travel to study site and monitor study as needed (up to 25% of the time.)
• Ability to develop, comprehend and edit scientific writing

RESPONSIBILITIES:

• Supports the medical/scientific contribution for preclinical and translational studies.
• Contributes and reviews synopsis, protocols, amendments, medical review of data, review of draft reports and publications, the search of medical/scientific information, literature review and analysis etc.
• Involvement in preclinical projects in development from the scientific assessment of a pre-clinical project to final deliverable.
• Assists the designs, authoring and/or reviewing pre-clinical study synopses, protocols, amendments, study reports, and other study-related documents.
• Performs all aspects of preclinical workflow including responsibility for managing CROs, data handling, logistics, bioassay, data management, and authorize reports.
• Prepares pre-clinical sections of registration documents; provides input on the preparation of other key pre-clinical documents for IND.
• Assists in database finalization, reviewing of study results and results interpretations.
• Assists in identifying/evaluating vendors.
• Assist with field site questions during the conduct of the pre-clinical study as neede