Clinical Study Director

Job Overview 

An opportunity has arisen for the position of Study Director, working in the Clinical Section of the Research & Development Department. 

Main Activities/Tasks 

The Study Director will work in a quality focus environment regulated to GLP standards. The successful candidate will lead, manage data and report non-clinical and clinical studies for safety and efficacy trials for animal health products. 

The successful candidate will be responsible for the planning, conduct and reporting of studies in an organised and timely manner, and in a Quality focus environment in accordance with Regulatory requirements (e.g. FDA/EMA), the principles of GLP, GCP, and SOPs in operation within the Research & Development Department.

You will be responsible for a wide range of study designs, including:

• Pharmacokinetic/Bioequivalence studies. 
• Residue depletion studies. 
• Target Animal Safety. 
• Laboratory Studies (dissolution and characterisation). 
• Clinical studies (artificial and natural infections). 

Essential Criteria:

• Educated to a minimum of degree level in a relevant life science discipline. 
• Flexible and be able to prioritise and time manage efficiently. 
• Proven commitment to work to defined deadlines.
• Excellent written and verbal communication. 
• Have good interpersonal skills. 
• Be assertive yet tactful. 
• Possess a strong team spirit with the ability to work as part of a multi-disciplined team. 
• Have a full UK driving licence. 

Desirable Criteria: 

• Have previous experience in the role. 
• Have previously worked in a GLP/GMP environment. 
• Have previous experience in in vitro experiments/models. 
• Previous experience in a laboratory with knowledge of bioanalytical method testing. 
• Have understanding of relevant regulatory guidelines. 

Duration: Permanent

Location: Newry 

Additional Information:

• Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered. 
• We regret that applications received after the closing date and time will not be accepted. 
• We are unable to sponsor or take over sponsorship of a Visa at this time. 
• This role is based on a site that produces penicillin and as such, would not be suitable for those with a penicillin allergy.

Benefits:

• Free life assurance
• Pension salary sacrifice scheme with 5% employer contribution 
• Healthcare cash plan
• 32 days annual leave (increasing with length of service) 
• Wedding leave 
• Enhanced Maternity / Paternity Pay 
• Company Sick Pay
• Subsidised Canteen Facilities
• FREE On-site parking
• Cycle to Work Scheme 
• Tech Purchase Scheme 
• Free Will-Writing Service 
• Employee perks/discounts scheme
• Employee Assistance Programme (EAP) 
• Employee well-being initiatives 
• Employee recognition scheme
• Career development opportunities​​​​​​​

Contact: recruitment@norbrook.co.uk ​​​​​​​