Medical Director, Senior Patient Safety Physician

4 weeks ago

Gaithersburg, Maryland, United States AstraZeneca plc Full time

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, eg 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.

This role will also require your medical input and review of periodic reports (eg 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 (eg 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

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.

AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next:

Are you already envisioning yourself joining our team? Good, because we can't wait to hear from you

  • We will be reviewing applications and shortlisting on a rolling basis - as such we reserve the right to withdraw this vacancy ahead of the stated closing date

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package

Date Posted

14-May-2024

Closing Date

02-Jun-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.

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