Location: Gaithersburg (3 days on site)Are you ready to bring your deep clinical understanding and judgement to a senior leadership role within Patient Safety at AstraZeneca? As a Senior Medical Director, Principal Patient Safety Physician, you will play a pivotal role in shaping the culture of our department and mentoring our junior staff. Your expertise will ensure our projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. Are you up for the challenge? Whe... more details
Senior Medical Director, Principal Patient Safety Physician - Oncology!
Location: Gaithersburg (3 days on site)
Are you ready to bring your deep clinical understanding and judgement to a senior leadership role within Patient Safety at AstraZeneca? As a Senior Medical Director, Principal Patient Safety Physician, you will play a pivotal role in shaping the culture of our department and mentoring our junior staff. Your expertise will ensure our projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. Are you up for the challenge?
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.
What you'll do
In this role, you will be responsible for providing strategic Patient Safety input to drug development and post-marketing programs. You will collaborate with team members to undertake safety surveillance activities and prepare high-quality evaluation documents to describe safety findings. You will also ensure experienced input to all elements of design and interpretation, including efficient use of tools and methodology (e.g. modelling and simulation). You will provide leadership to support project discussions with governance boards, including interactions with Patient Safety Peer Review Committee. You will lead the safety strategy for regulatory communication and provide oversight of higher-level documents to support submission activities. Lastly, you will lead medico-scientific contributions to RMPs for assigned products and to Periodic Reports, including PBRERs, DSURs.
More broadly you are expected to participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external collaborators.
Essential for the role
Degree in medicine and experience as a physician or academic clinician
Extensive experience in Pharmacovigilance, with clear evidence of delivering to a high standard
Detailed understanding of pharmaceutical safety, reporting and surveillance processes and strong experience of Patient Safety, as it relates to clinical trials and marketed products in any relevant field such as pharma, Regulatory Agency or Public Health agency
Experience in designing, monitoring and implementing clinical trials and interpreting trial results
Strategic leadership of complex drug projects
Understanding of the medico-legal aspects of pharmacovigilance
Shown leader of cross-functional delivery teams.
Demonstrated ability to influence key business partners within and outside of company
Proficiency with both written and verbal communications
Desirable for the role
PhD in scientific field
Therapeutic area expertise and commercial understanding
Extensive general medical knowledge
Able to work across TAs and Functions
Research background, including peer reviewed publications
Why AstraZeneca
At 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 ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Date Posted
17-Apr-2024
Closing Date
06-May-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.
