Associate Medical Director, Clinical Development Sciences

Boston, MA

Employer:	AstraZeneca
Job Type:	Full Time
Description
This is what you will do: Seeking a physician with 3-5 years of clinical research or clinical trials experience in industry or equivalent experience in academia or hospital system. The primary role is to work within the Hematology/Nephrology Clinical Development Department. This individual will serve as a medical monitor for the assigned study(ies) which are typically phase 1-4 clinical trials, or other studies as directed by the line management. This position additionally offers substantial opportunities for regulatory and commercial interactions and career advancement in the fast-moving area of rare disease. You will be responsible for: Medical Expert for clinical study team Medical Monitor for the assigned trials or studies Medical Data Review Protocol development from concept to final protocol Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring Strategic guidance to phase II/III development programs and oversight of global clinical trials/trial team (s) on assigned program(s) Presentation at academic congresses, investigator meetings and advisory meetings Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents Particiapte in or lead ad hoc clinical development projects as directed by line management You will need to have: Medical doctor (MD) or foreign equivalent physician education History of industry, academic or hospital-based clinical or basic science research Excellent written / oral communication skills Ability to think strategically Attention to detail Interest in career progression and taking and willingness to take on new responsibilities The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: Formal training or education in clinical trials, epidemiologic design, statistical methods and/or quantitative sciences. Master degree in clinical research or related field preferred 1-2 years of industry experience Previous clinical trial experience as medical monitor in industry setting Safety medical monitoring and reporting experience Protocol development experience Understanding of regulatory requirements related to clinical trials e.g. FDA, EMA, MHRA Publication in peer reviewed journals Presentation of conference abstracts in international conferences 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.

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Associate Medical Director, Clinical Development Sciences

Boston, MA

Description