Role: Medical Director, Senior Patient Safety Physician
Location: 3 days onsite in Gaithersburg
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's outstanding skills with those of people from all over the globe!
As a Medical Director, Senior Patient Safety Physician in Gaithersburg, UK you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives. Oncology R&D global development drives our innovative pipeline, redefining science into valued new medicines and ensuring patients around the world can access them.
AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with a broad pipeline of next-generation medicines. Our pipeline is focused principally on four disease areas - breast, ovarian, lung and haematological cancers. As well as other tumour types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates. All of this delicious new science is underpinned by personalized healthcare and biomarker technologies.
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, modelling 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 SERM activities for all products in area of responsibility.
Essential Education, Experience and Skill Requirements
Medical degree (e.g. MD, MBBS).
At least 2+ years of clinical experience post-registration, industry experience is preferred
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.
Preferred Education, Experience and Skills
MSc/PhD in scientific field
Able to work across TAs and Functions
Experience managing Patient Safety colleagues
A demonstrated ability to understand epidemiological data
The annual base pay 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.
In Office Requirement:
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
So, what's next:
Are you already envisioning yourself joining our team? Good, because we can't wait to hear from you!
Why AstraZeneca?
At AstraZeneca's Oncology R&D business area, you'll be part of a team playing a critical role in driving meaningful change in the way we predict, prevent and treat patients' conditions. We're actively embracing and investing in technology, harnessing digital, data and analytics to reimagine the future of healthcare and deliver improved outcomes to patients beyond core medical. We're shaping the future, improving and speeding up portfolio development, improving the patient experience and outcomes at clinical trials. Join the team that is co-creating a digital ecosystem with patients at its core.
Date Posted
04-Nov-2024Closing Date
23-Nov-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
