Clinical Research Physician, Late-Stage Respiratory (Gaithersburg, MD)
As a Clinical Research Physician, you will support the clinical project team and assist the Global Clinical Lead (GCL) with the design & interpretation process, establishing clear design objectives for clinical programs and studies.
You will provide medical input into the content of core labeling texts and medical support for commercial activities, as well as the scientific component of the pricing and value strategy.
You will also provide medical and scientific expertise as well as tactical and strategic medical input to the development of AstraZeneca’s compounds;
primarily from Phase II to Phase IV.
In the Biopharma R&D unction, you will be given the opportunity to work in a truly international working environment, with opportunities to meet and discuss with key opinion leaders, other medical colleagues and experts in basic science, as well as commercial and regulatory functions.
Our therapy area aligned groups of physicians and scientists provide clinical guidance and scientific leadership for clinical development programs within AstraZeneca's global organization.
The successful candidate will work in a wide range of aspects in pharmaceutical medicine, and due to the global responsibilities, there will be a multitude of contacts with health authorities, colleagues and marketing companies within AstraZeneca.
This is an opportunity to take on the challenges of clinical development in a group of positive, focused and highly motivated colleagues.
Typical accountabilities :
In this position, you will be involved in providing medical and scientific leadership in the global development of new medicines targeted at indications in the field of respiratory disease.
You will have an important role providing medical and scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programmes.
You will be involved in building strong relationships with a network of external scientific experts and opinion leaders.
You will work closely with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations.
You will be involved primarily in late stage (Ph2b and later) clinical programs, but will also be expected to collaborate with clinical colleagues supporting early stage programs as well as medical affairs colleagues.
You will provide expert medical input into the preparation of regulatory documents and interactions with regulatory authorities.
You will provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature.
You will participate in the preparation of publications and presentations at scientific meetings and congresses.
Essential Requirements :
You are a fully qualified physician (MD or MD PhD) with pharma industry experience in late stage clinical drug development.
You have significant experience in the design, execution and interpretation of clinical trials. Your background in one or more of the following therapeutic areas inflammatory disease, respiratory, oncology, immunology, gastroenterology, rheumatology, cardiology but also other specialties could qualify.
You have good teamwork and collaboration skills
You have good verbal and written communication skills in English
You are able to travel nationally and internationally