Associate Medical Director, Clinical Development Sciences
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
1-2 years of industry experience
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
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
The annual base pay for this position ranges from $177,699.20 - $266,548.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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.