Medical Director, Patient Safety Physician at AstraZeneca in Gaithersburg, Maryland

Job Description:

At AstraZeneca, Global Patient Safety (GPS) is at the forefront of defining and optimizing the safety profile of our medicines across their lifecycle in all therapeutic areas. GPS leads the way in integrating science, data, and technology to shape clinical safety strategies. From monitoring and detection to characterization and reporting of adverse events, GPS plays a critical role in ensuring the safety of our medicines for patients worldwide.


As a Medical Director, Patient Safety Physician in Patient Safety BioPharma, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. BioPharma Global R&D drives our innovative pipeline, redefining science into valued new medicines and ensuring patients around the world can access them.



Main Duties and Responsibilities:



In this role, you'll be responsible for the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level. Essentially, the continued safety assessment, evaluation and risk management of AZ products or product groups in various stages of clinical development and/or the post-marketing setting as well as the continuous efficient evaluation of adverse event and all other safety information will be within the remit and scope of this role.


You will provide consistent communication of safety topics across all regulatory safety documents, e.g. Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs) and Development Safety Update Reports (DSURs), for assigned product(s)/program(s).


You will proactively evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature to predict / establish the safety profile of compounds in clinical development. This process includes employing expert groups and methodologies such as Safety Knowledge Groups (SKG's), Safety Science, Informatics expertise, modeling and simulation to manage the risk to patients. Additionally, you'll be involved in all safety surveillance activities, that may include: medical review of individual safety cases (providing medical expertise and judgment), signal detection, evaluation and safety information review committee activities for all products in area of responsibility.


This role will also require your medical input and review of periodic reports (e.g. PBRERs, PSURs, or DSURs) and renewal documentation submitted to regulatory agencies and the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc.) for new products, formulations or indications.



Essential Education, Experience and Skill Requirements

• Medical degree (e.g. MD, MBBS).


• At least 2+ years of clinical experience post-registration


• High level of medical competence, with an ability to balance this with industry standards to achieve business goals.


• At least 2+ years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery.


• Ability to work effectively in an advanced matrix structure


• Proficient in written and verbal English

Preferred Education, Experience and Skills

• MSc/PhD in scientific field


• Experience managing Patient Safety colleagues


• A demonstrated ability to understand epidemiological data

The annual base pay (or hourly rate of compensation) for this position ranges from $233,290 to $349,935. 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. Apply Now