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Job Details

Pre Clinical Safety Director

Company: TEC Group International
Location: Düsseldorf
Reference: CGPCSE9872
Closing Date: 26 Nov 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

The Preclinical Safety Expert will support preclinical subteams by developing preclinical safety strategies and plans (safety pharmacology and toxicology), execution of external preclinical studies, monitoring and reporting study results. The position holder ensures that all preclinical safey data is available in high quality to support clinical development activities.

Requirements:

Official Title: Preclinical Safety Expert/Director

Location: Dusseldorf area, Germany

Reports to: Head of Preclinical Safety

The Preclinical Safety Expert will support preclinical subteams by developing preclinical safety strategies and plans (safety pharmacology and toxicology), execution of external preclinical studies, monitoring and reporting study results. The position holder ensures that all preclinical safey data is available in high quality to support clinical development activities.

Major duties, accountabilities and responsibilities

* Preparation of development plans for preclinical safety studies (toxicology and safety pharmacology) of drug candidates
* Support of preclinical teams with respect to toxicological and safety pharmacological studies/programs
* Conduct of preclinical GLP-safety studies at contract research organizations (CROs) as study monitor
* Scientific evaluation and interpretation of results from preclinical safety studies
* Presentation of results in preclinical teams and in front of senior management
* Preparation of toxicological expert statements for active substances, impurities and excipients
* Preparation and review of preclinical safety parts of regulatory documents (IND, CTD, IMPD, IB, briefing books etc.)
* Responses to request form national and international agencies related to questions on preclinical safety studies

The Person

* Completed study in veterinary medicine or natural science with academic degree
* Several years of experience in the pharmaceutical/biotechnology industry or a contract research organization in regulatory toxicology and or safety pharmacology
* Additional qualification as expert in toxicology would be desirable
* Knowledge of working under Good Laboratory Practice regulations and guidelines (ICH, EMA, FDA etc.) for preclinical development of drug candidates
* Excellent communications skills, team spirit and assertiveness
* Experience with self-contained working in multi-disciplinary teams
* Fluent in English. Must be open to learning German language skills

Application and Interview Process

TEC Group will be compiling a shortlist of up to 5 candidates to recommend to the stakeholders at Grunenthal to fill this opening. You can expect to have a further in depth conversation with Christopher Gibson who will discuss the position and company with you at length, as well as discuss your current situation, skills & competencies and key achievements. Chris will be aiming to understand what value you can bring to this business and will use this information to compile the final shortlist of recommended candidates. The deadline for shortlist submission is 08th March 2017, however it may be presented before this deadline.

Should TEC Group plan to include your profile on the shortlist, you can be expected to be contacted by TEC Group to arrange a further conversation with Christopher which may take place via video conference or face to face. This meeting will take place in the days leading up to the deadline date. The interview process is expected to be thorough but nonetheless fairly fast-moving. This will include meeting with the Head of Preclinical Safety at the company as well as meeting some other senior stakeholders within the business. There will likely be two trips to the German HQ involved as part of this process.

We are expecting a decision to have been made and an offer to have been extended by mid-end of April 2017.

Apply for this job: Pre Clinical Safety Director

Contact Information:

Address:  Head Office
Dowgate Hill House, 14-16 Dowgate Hill, London
EC4R 2SU
England
Tel:  +44 (0) 208 544 3400
Website:  Visit Our Web Site

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