Clinical Trial Lead, EU region
|Contact Name:||Larry O’Leary|
Our client is a highly ambitious young US pharmaceutical company with an impressive track record of building highly successful global businesses. Its strategy is to acquire early and late stage development projects to expand existing product portfolio in focused therapeutic areas. Additionally this company are revenue generating which brings financial security.
The Company's management team has extensive experience in completing pharmaceutical acquisitions in a timely and collaborative manner, to the benefit of both parties. It has experience in a range of transaction structures including in-licensing and acquisition transactions, distribution, royalty and co-promotion agreements, and research and development collaborations.
Ambitious expansion plans have led to the establishment if this exciting newly created management position. This opportunity offers a rare chance to make a key contribution towards building a successful ambitious young company. The post holder will gain a wealth of experience across a wide spectrum of the industry including full spectrum of dosage forms, as well as Clinical Development, Clinical Operations, Regulatory Clinical and CMC, and Clinical Manufacturing.
In response to this medical need and based on encouraging progress of their clinical development pipeline , our client now seeks to appoint a Lead for their Clinical Trial function, managing the EU region and will be based in Dublin, Ireland.
? Preferred candidates will be educated to Masters level degree, Bachelor's Degree at minimum.
? Ideally candidates will have 10-15 years of relevant clinical study / program management experience in the biotechnology or pharmaceutical industry, including line management experience.
? Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
? Experience in more than one therapeutic area is highly desired and trial recruitment experience.
? Candidate will be a superb communicator of technical and scientific information and possess excellent interpersonal skills & strong organization skills.
? Ability to liaise and manage stakeholders at all levels, including; Finance, Legal, Procurement / Supply Chain, Regulatory bodies, Ethics Committees, Public bodies, etc.
For further details, please contact Larry on 01-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie