Medical Director, Senior Patient Safety Physician

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, MD, you’ll play a pivotal role in channeling 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 hematological cancers. As well as other tumor 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, 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 SERM 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 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.
  
  

Desirable Requirements:

• MSc/PhD in scientific field.
• Able to work across TAs and Functions.
• Experience managing Patient Safety colleagues.
• A demonstrated ability to understand epidemiological data
  
  

Employer of choice

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.

Are you intrigued by what you'd be doing in this role? Do you have the creds required? If so, we can't wait to hear from you! And wait, there's more...

We offer a world class Total Reward program including a market driven base salary, bonus and long term incentive awards. We also provide a generous paid time off program and a comprehensive full scope benefits package.

AstraZeneca aligns with all applicable laws and regulations on inclusivity in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

To safeguard the health and wellbeing of our employees, customers and communities, AstraZeneca is mandating COVID-19 vaccination for all US-based AstraZeneca and Alexion employees. We will provide accommodations for those unable to be vaccinated based on applicable law, such as those who cannot get vaccinated due to a medical or religious reason. We continue to work diligently to ensure the health and safety of our employees and workplaces and have in place a number of safety measures and guidelines, including providing access to personal protective equipment and COVID-19 testing.