- Advert number: 323188-0
- Posted Date: 05/02/13
- Closing Date: 22/02/13
Associate Medical Director - Oxford
Vertex creates new possibilities in medicine. Our team discovers, develops and commercialises innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognised as one of the industry’s top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex’s press releases, please visit www.vrtx.com
As Associate Medical Director, you will draw on your full understanding of US and EU drug development regulations and GCP regulations to act as Medical Monitor for assigned Clinical Trials and take responsibility for monitoring the safety of enrolled subjects. It will see you work on multiple trials simultaneously on more than one program comprised of Phase I, Phase II, and Phase III studies.
A UK based role, working closely with a UK based global Medical Director, you will participate in the development of protocols, Investigators’ Brochures and Clinical Development Plans, and serve on the Study Executive Team (SET). Researching and recommending methods to resolve clinical development problems, you will take part in the preparation of regulatory documents by providing scientific and clinical input and content review. You will also input into protocol related documents and analysis plans.
As liaison between clinical development department and internal regulatory affairs for assigned programs, you will also provide clinical input to respond FDA letters. Additionally, you will represent us to external medical personnel in the development of Phase 1 clinical protocols, and solicit input and opinion.
Together with an MD, DO or equivalent ex-US medical degree, or a doctoral degree, you will have basic or clinical research experience in an academic or industrial setting with experience in publications. A background in clinical drug development will be key, as will your ability to work collaboratively in a team-based matrix environment and to function autonomously as appropriate. You will have a full understanding of applicable US and EU drug development regulations and GCP regulations, and a working knowledge of biostatistics and pharmacokinetics. In addition you should be familiar with interacting with regulatory authorities.
In return, you can look forward to an impressive benefits package that includes 28 days’ holiday, employee stock purchase plan and group stakeholder pension. As you would expect, we are highly health-aware, so you will also be eligible for private medical, dental and optical insurance as well as life insurance. Plus you can take advantage of our work place nursery and gym membership.
If you are innovative and focused on achieving success within a
collaborative environment, please visit our website www.vrtx.com to find
out more information and apply.
Closing date for applications is 22 February 2013.