Safety Director jobs in Gaithersburg, MD

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.

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.