AstraZeneca Pharmaceuticals LP Clinical Scientist, Respiratory Global Medicines Development in Warsaw, Poland
Clinical Scientist, Respiratory Global Medicines Development
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
The Clinical Scientist will provide scientific and clinical input to all aspects of late stage product development. This includes but is not limited to the, design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of Respiratory products in late stage development. The Clinical scientist ensures that the safety evaluation process for the pivotal phase III trials is seamless and complete.
In this role the clinical scientist would seek input from the appropriate functional experts and coordinates these activities in support of clinical studies and programs. The objectives of the Clinical Scientist will be set by the Group Director in agreement with the Clinical Global Lead(s). The current role will have a special focus on late stage clinical trials within the respiratory where the Clinical scientist will work in close collaboration with the study team physician with all aspects of scientific input, clinical data quality metrics and safety evaluation
Responsibilities will include:
You will have an important role providing scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs. Working 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 be expected to collaborate with clinical colleagues supporting early stage programs as well as medical affairs colleagues. Providing expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities.
Providing expert scientific analysis and interpretation of data from ongoing studies and in the literature. Leading development of quality metrics and data review plan for assigned studies. Supporting and contribute to medical monitoring of trials. You will assume other duties as assigned by the Group Director.
Scientific doctoral level degree (e.g. PhD or PharmD), relevant equivalent clinical qualification (MD or equivalent), or other relevant university degree with extensive experience from clinical development.
Strong and relevant pharmaceutical industry experience (multi-country clinical trials) is required.
Understanding of scientific and clinical issues related to the design and implementation of clinical trials and interpreting trial results.
Proven ability to work collaboratively in a cross-functional setting, particularly with patient safety, vendors, CRAs, Site staff and clinical operations.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law