Senior Global Development Medical Director

EMPLOYER:  AstraZeneca Pharmaceuticals LP

TITLE:  Senior Global Development Medical Director

LOCATION:   Gaithersburg, MD

HOURS:  Full-Time; Mon-Fri (40 hours/week)

DUTIES:  Manage global or regional therapeutic or research projects and serve as expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials.  Oversee development of the functional strategy or acting as a renowned expert in own field.  Design or manage the implementation of the Physicians strategy within Clinical Development both regionally and globally. Lead responses to complex technical issues for specific medical aspects in relation to current projects, new projects and various plans. Ensure qualified physicians are available for clinical testing. Lead regulatory communication and preparation of higher level documents.

REQUIREMENTS: Must possess a Doctorate degree, or foreign equivalent, in Medicine, Pharmaceutical Science or a related field, plus three (3) years of progressive, post-baccalaureate experience in the job offered, as a Study Physician, or in a related occupation. Must possess three (3) years of experience with all of the following: Designing, monitoring and implementing clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements; Conducting pre-clinical studies, epidemiological studies, diagnostic studies; Serving as a trial level physician and medical monitor for clinical studies; Developing pharmaceutical safety, reporting and surveillance processes to identify noncompliance; Leading risk assessment and re-evaluation of ongoing trials; Conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data; Drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions; Serving as a contributing author to scientific publications and data presentations at scientific conferences. 5% domestic travel required.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Click Apply to submit your application. No calls please.  EOE.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.