Job Description

CK Group are recruiting for an Associate Director, Bioanalytical Outsourcing to join a Clinical Stage Biotech.

The Role:

You will be joining the Translational Medicine team. You will provide day to day scientific and operational oversight ofoutsourced and internal bioanalysis (e.g. PK, immunogenicity, and routine biomarker analysis) in support of clinical development programs.

Responsibilities:

• With minimal supervision, coordinate and oversee assay transfer/development, assay validation, bioanalysis, and troubleshooting of bioanalytical methods used for analysis of clinical samples (e.g. PK, immunogenicity, and routine biomarker assays) at external CROs and internal laboratories.
• Participation in the selection, qualification, management, and audit external CROs.
• Evaluate and review raw data and study analytical reports and assay validation reports, as appropriate, to ensure laboratories are performing analysis in compliance with current regulatory and industry standards and that data are of the required quality (regulatory and scientific).
• Foster collaborative and productive cross-functional relationships to ensure efficient exploration and implementation of novel biomarker assays.
• Review relevantsection of clinical development plans, clinical study reports, clinical trial protocols, lab manual and regulatory documents.

Background:

• A PhD. in a related field and extensive industry industry biotech/pharmaceutical experience with theconduct and oversight of bioanalytical methods and study support. Alternatively, extensive regulated bioanalytical experience will be considered.
• Experience in clinical study translational research.
• Demonstration of strong scientific acumen andknowledgeable of the oncology disease area.
• Strong project management skills.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55955 in all correspondence.

CK Group