|
WHAT
IN
Medical Director Cystic Fibrosis
Job
Vertex Pharmaceuticals
US
-
Cambridge,
Massachusetts
Job Code - 1060BR
Position - FULL TIME
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to Vertex Pharmaceuticals for this position!)
JOB DESCRIPTION: Medical Director, Cystic Fibrosis
Vertex Pharmaceuticals is currently searching for an Associate Medical Director / Medical Director to join the Clinical Development team to assist with the advancement of several programs currently in the drug development process.
The Medical Director serves as Medical Monitor for Clinical Trials, ensuring compliance with GCP regulations and monitoring the safety of enrolled subjects. Generally works on multiple trials or more than one program at a time comprised primarily of Phase II and Phase III studies. In this position you provide program level clinical support across multiple programs in the area of cystic fibrosis.
Key Responsibilities:
• Act as the Medical Monitor for clinical trials
• Develops clinical protocols, investigator's brochures and clinical development plans (in coordination with the Clinical Program Manager) with emphasis on scientific and safety matters, with minimal guidance
• Represents Vertex to outside medical/scientific experts in the development of the clinical protocols, solicitation of input and opinion, and presents at conferences and symposiums
• Utilizes novel and creative methods to resolve clinical development problems independently
• Acts as liaison between clinical development department and internal regulatory affairs for assigned programs
• Be a direct participant in clinical trials
• Contribute to the production of regulatory documents such as IND filings, IND annual reports and EU regulatory submissions
• Be the primary Vertex liaison to academic medical experts and investigators
REQUIREMENTS - QUALIFICATIONS: Medical Director, Cystic Fibrosis
• MD, DO or equivalent ex-US medical degree
• 1-2 years of basic or clinical research experience in an academic setting with publications in peer reviewed journals
• 5+ years of experience in Clinical Development in the pharmaceutical industry
• board certification in Internal Medicine or a similar medical specialty
• Excellent communication skills
• Ability to work collaboratively in a team-based matrix management environment with minimal supervision
• Possess a full understanding of applicable US and EU regulations and of the drug development process
• Have a working knowledge of biostatistics and pharmacokinetics
• Experience in filing and defending US IND's or similar ex-US regulatory submissions
Preferred qualifications include sub-specialty training in internal medicine, family practice, pediatrics, pulmonary medicine or allergy.
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, cancer, and pain. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Vertex Pharmaceuticals
Back To Results
Apply to this job!
View Company Jobs
Free Career Test
Your Resume on 75 Job Sites
|
The goal of CareerTopJobs is to help candidates find
jobs more easily, like the job listed on this page, "Medical Director, Cystic Fibrosis, in Cambridge, Massachusetts - Vertex Pharmaceuticals". We hope CareerTopJobs will become your job source for finding open job positions in the
Biotechnology and
Pharmaceutical industry job market.
