Company: Barrington James Clinical
Reference: cs med
Closing Date: 15 Feb 17
Type: Full Time
Salary (£): Competitive
The Exploratory Medicine Director is accountable for providing clinical drug development support and expertise to the project teams successfully to deliver the clinical studies Pre POC.
This support will include leadership and advice on all clinical aspects of Early Drug Development including Clinical input into regulatory strategies, development plans, protocols and feasibility studies. This expertise will complement the therapeutic expertise provided by the TA clinical specialists.
The Exploratory Medicine Physician will achieve this by working as a key member of the Clinical Regulatory Sub-teams of the project and may lead this sub-team. They will work closely with the other members of the
CRST to develop a clear and feasible Clinical Development Plan. They will be seen as an expert in all clinical aspects of the learn phase of drug development and will partner with TA clinical experts to provide
New Medicines with high quality medical expertise.
They will develop and maintain a network of KOLs with expertise in running exploratory development studies focussing on experimental medicine patient studies. In addition to project work they will work with internal and external therapeutic experts to establish experimental medicine study methodology that can be incorporated into clinical development programs.
Strategy and Leadership
1) Lead the Clinical Development input into the project teams
2) Work in partnership with TA clinical experts to ensure all Clinical aspects fo the the CDP are of high
quality and feasable
3) May lead clinical regualtory sub team
4) Lead experimental medicine study design and qualification
5) Establish KOL network for delivery of experimental medicine studies
1) Lead qualification and delivery of experimental medicine studies
2) Lead clinical aspects of regulatory meetings for pre POC projects
3) Ensure Clinical Feasability of CDP and individual protocols
Significant experience in Early Drug Development
Expert knowledge of early clinical development with proven track record of successful contribution to
Has run clinical studies across a range of therapeutic areas
Has been clinical lead at Regulatory meetings with EMA and or FDA
Specific skills : (Include specific skills and knowledge necessary to meet the objectives of the position)
Knowledge of overall drug development process.
Recognised expert in delivery of early clinical trials
Strong understanding of drug regulatory framework particularly with respec to early studies
Ability to communicate effectively with internal and external opinion leaders including pharmaceutical
regulatory agencies, e.g. FDA, EMEA).
Ability to work in a matrix type environment.
Problem solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and
High performer, strong team-commitment. Is innovative, can manage uncertainty.
Ability to work independently and to solve complex problems and multiple projects in supervisory capacity.
Must be a strong team player with abilities to work in a multicultural envorinment.
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