Location: Harrow- Middlesex
Closing Date: 26 Oct 16
Salary (£): Competitive
The primary role of the Associate Medical Director is to act as PI on pivotal studies, to provide senior oversight to the medical group, and medical support for the activities of the Early Phase Unit.
Associate Medical Director- Early Phase
The primary role of the Associate Medical Director is to act as Principal Investigator (PI) on pivotal studies, to provide senior oversight to the medical group, and medical support for the activities of the Early Phase Unit.
• To deputize for the Medical Director, as and when necessary.
• To ensure that the medical activities of the unit conform to industry standards and regulatory requirements.
• To perform the duties of Principal Investigator during clinical trials according to International Conference on Harmonization Good Clinical Practice (ICH GCP) and to the highest standards to ensure that welfare of the subjects and the quality and credibility of study data is maintained.
• To liaise proactively with hospital specialists, GPs, consultants and others to recruit suitable volunteers and patients for clinical trials.
• To provide business development support by meeting with sponsors and assisting in feasibility activities.
• To assist Physicians in the clinical studies performed in the Unit. •
• To liaise with Sponsors during protocol development, regarding aspects of protocols such as design and safety and provide input into dose escalation discussions.
• To represent the unit and PAREXEL at national and international meetings, seminars, workshops and congresses.
• MB BS or equivalent
• GMC registration
• Diploma in Pharmaceutical Medicine or other relevant postgraduate qualification
Minimum Work Experience:
• Appropriate experience in clinical pharmacology in early phase I/II studies.
• Leadership and team work skills.
• Excellent personnel manager with strong negotiation skills.
• Outstanding communicator.
• Suitable knowledge of drug development including preclinical toxicology, pharmacology, pharmacokinetics and Regulatory requirements.
• Competent IT skills
• Previous experience as an Associate Medical Director in an Early Phase unit or comparable role.
• Strong understanding of Pharmacokinetics and preclinical toxicology.
• Postgraduate Business qualification.
101-105 Oxford Road
|Tel:||+44 1895 238000|
|Fax:||+44 1895 238494|
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