Head of Clinical Assays

Location
Oxfordshire
Salary
Competitive - Negotiable
Posted
09 Aug 2017
Closes
16 Aug 2017
Ref
J4267
Contact
Eve Hegarty
Contract Type
Permanent
Hours
Full Time
We are currently working exclusively with a growing biotech company based in Oxfordshire in their search for a Head of Clinical Assays.

This is a great opportunity to take ownership of a new function within the business, and grow your own team.

As the Head of Clinical Assays you will be responsible for recruiting and leading a small team of scientists responsible for generating biomarker and activity data from clinical trial samples and providing strategic input into translational approaches for the company's therapeutic candidates.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Head of Clinical Assays will involve three main components:

1. Coordinating sample testing at external contract testing organizations (CTO's).
2. Managing small team of scientists focused on assay development and non-GLP testing of clinical samples to provide exploratory endpoint data.
3. Analysis and reporting of data, written and verbal, including providing strategic input to translational activities.

The overall responsibilities will be varied, however the key duties and responsibilities are as follows:

1. Interactions with Contract Testing Organisations - Identification and selection of suitable organizations; acting as technical representative for site audits; assay transfer and trouble-shooting; establish and maintain close and effective communication links with key contacts; cover assay development and CTO engagement for any required in vitro GLP toxicology studies.

2. Data Analysis and Reporting - Use of suitable software to analyse, tabulate and graphically represent assay data; interpret and draw conclusions from the data, and communicate these effectively in presentational and/or written formats as needed; develop hypotheses based on the data and broader knowledge to help guide further analyses and/or guide future studies; write and review appropriate sections of regulatory documents.

3. Line management and broader team activities - Line manage and develop the capabilities of team members; integrate activities of the team within the broader remit of the research group, including flexibly helping to resource non-clinical assay work as/when required; establish close and effective working relationships both within the Research team and with the Development organization, particularly the Director of Translational Medicine and members of the clinical and quality teams.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Head of Clinical Assays, candidates should have significant relevant experience post PhD / BSc, within the Biotech/Pharma industry, with the following further requirements:

1. Experience of outsourcing to contract laboratories, including management and auditing as well as an understanding of laboratory requirements to meet quality guidelines / regulations as part of sampling and testing in a clinical trial.

2. Strong experience using relevant data analysis & graphical software packages (e.g. JUMP, PRISM, Excel) together with a good knowledge of statistics.

3. You will require experience developing and validating assays suitable for the analysis of clinical samples, ideally within an immunology or oncology setting. This includes experience of immunoassays, qPCR / RT-qPCR, flow cytometry, gene expression profiling, immunohistochemistry.

4. You will have some experience line managing, matrix managing or supervising a team of scientists.

Key Words: Clinical Assays | Head of | Manager | Clinical Samples | Clinical Trials | Immunology | Oncology | Biotech | Pharma |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.