Senior Director, Preclinical

Jim Gleeson is recruiting for a Senior Director, Preclinical to join an exciting, clinical stage biotech developing Autoimmune treatments.

The role will be office based in Oxford.

RESPONSIBILITIES:

As Senior Director, Preclinical you lead Preclinical, PK/PD and Bioanalytical development efforts supporting the portfolio of therapeutic monoclonal antibody therapeutics.

Key duties will include:

• Overseeing the design and management of pre-clinical studies (GLP and non-GLP) for inclusion in CTA or IND submissions, including PK and biodistribution, toxicology, and CMC supporting studies
• Overseeing the selection and management of consultants and CROs to support pre-clinical development programs
• Overseeing the drafting ofthe relevant sections and individual reports to support regulatory filing including pre-IND, IND, IB, and clinical lab manuals
• Collaboration with company scientists on clinical development plans

QUALIFICATIONS:

As Senior Director, Preclinical you will require:

• PhD in immunology or related subject with extensive experience of project management of preclinical/translational development of biotech/biopharma products
• Comprehensive understanding of biotech/biopharma product development and stages of drug discovery
• Demonstrated knowledge of GLP regulations related to preclinical study planning and bioanalytical method development
• Proven experience selecting and managing CRO relationships
• Experience managing direct reports and project teams

BENEFITS:

Very competitive salary plus an excellent benefits package.

APPLY: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53952 in all correspondence.