Senior Medical Director, Principal Patient Safety Physician

3 weeks ago


Gaithersburg, United States AstraZeneca PLC Full time

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.



  • Gaithersburg, United States AstraZeneca, plc Full time

    As a Medical Director, Senior Patient Safety Physician in Gaithersburg, UK youll 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 innovat Medical Director, Patient, Director, Senior, Medical, Physician


  • Gaithersburg, 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...


  • 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...


  • Gaithersburg, 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...


  • Gaithersburg, United States AstraZeneca PLC Full time

    Job Title: Director Principal Patient Safety Scientist Location: Gaithersburg MD At AstraZeneca, we deliver life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Crafting a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. Our strategy and...


  • Gaithersburg, United States AstraZeneca PLC Full time

    Role: Medical Director, Patient Safety Physician Location: Onsite 3 days 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...


  • Gaithersburg, United States AstraZeneca, plc Full time

    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. Thats why we work, on aver Medical Director, Patient, Director, Oncology, Medical, Physician


  • Gaithersburg, United States AstraZeneca Full time

    Associate Director, Patient Safety Scientist Location: Onsite 3 days in Gaithersburg This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programmes, spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists and Physicians play a strategic role in developing our medicines and the...


  • Gaithersburg, United States AstraZeneca Full time

    Join our globally-renowned Oncology area, which is owning the rapid business growth of our enterprise and ever-evolving industry. As the Senior Director, Medical Diagnostics – Oncology, you will ensure the timely, high-quality input into development and lifecycle plans, supporting efficient companion diagnostics/testing solutions to enable efficient...


  • Gaithersburg, United States AstraZeneca PLC Full time

    Join our globally-renowned Oncology area, which is owning the rapid business growth of our enterprise and ever-evolving industry. As the Senior Director, Medical Diagnostics - Oncology, you will ensure the timely, high-quality input into development and lifecycle plans, supporting efficient companion diagnostics/testing solutions to enable efficient...


  • Gaithersburg, United States AstraZeneca PLC Full time

    Job Title: Senior Scientist, Oncology Safety Science Introduction to role: Are you ready to contribute to the discovery of novel oncology medicines? We are seeking a highly motivated Senior Scientist to join our team. This role will design and execute experimental strategies to enhance our investigative toxicology capabilities and drive our safety science...


  • Gaithersburg, United States AstraZeneca PLC Full time

    Director / Associate Director - Oncology Safety Science & Discovery, Tumor Targeted Delivery Location: Gaithersburg, Maryland At AstraZeneca, it is our bold ambition is to eliminate cancer as a cause of death. This is underpinned by our rich pipeline aimed to deliver innovative treatment options for patients. Oncology Safety colleagues contribute to this...


  • Gaithersburg, United States AstraZeneca PLC Full time

    Are you an expert within Safety Pharmacology with extensive knowledge in designing and interpreting high quality studies, translating scientific findings into applicable information in a drug development environment? Be part of a dedicated Research & Development team. Fuelled by our commitment to help more patients, strengthen our pipeline and grow our...


  • Gaithersburg, United States AstraZeneca PLC Full time

    Job Title: Associate Director, Oncology Safety Science Introduction to role: Are you ready to make a significant impact in the world of oncology? We are seeking a highly motivated Associate Director to support the development of novel oncology medicines with a focus on T Cell Engagers for haem and solid tumor indications. This is your chance to be part of...


  • Gaithersburg, United States FPC of Atlanta Full time

    Highly respected Biopharmaceutical Company seeks a Senior Director of Engineering to direct engineering and maintenance activities at this commercial scale biopharmaceutical manufacturing facility, ensuring compliance with regulations, driving continuous improvement, and managing site investments for the long term.Responsibilities:Lead engineering and...


  • Gaithersburg, United States FPC of Atlanta Full time

    Highly respected Biopharmaceutical Company seeks a Senior Director of Engineering to direct engineering and maintenance activities at this commercial scale biopharmaceutical manufacturing facility, ensuring compliance with regulations, driving continuous improvement, and managing site investments for the long term.Responsibilities:Lead engineering and...


  • Gaithersburg, United States FPC of Atlanta Full time

    Highly respected Biopharmaceutical Company seeks a Senior Director of Engineering to direct engineering and maintenance activities at this commercial scale biopharmaceutical manufacturing facility, ensuring compliance with regulations, driving continuous improvement, and managing site investments for the long term.Responsibilities:Lead engineering and...


  • Gaithersburg, United States Cartesian Therapeutics Full time

    **Summary**: The Director of QC Microbiology oversees the execution of the microbiology program supporting lot release and environmental monitoring for Cartesian. They will have proven leadership skills and success working well in a team environment as they will be tasked with building out the QC Microbiology team. **Principal...


  • Gaithersburg, United States AstraZeneca, plc Full time

    Do you have expertise in, and a passion for, improving patient access, awareness, and inclusion in clinical trials? Would you like to apply your expertise to craft the future of innovative patient recruitment in a company that follows science and tur Director, Patient, Healthcare, Patient Access, Operations, Clinical Research


  • Gaithersburg, United States Selecta Biosciences Full time

    Summary The Director of QC Microbiology oversees the execution of the microbiology program supporting lot release and environmental monitoring for Cartesian. They will have proven leadership skills and success working well in a team environment as they will be tasked with building out the QC Microbiology team. Principal Duties/Responsibilities: *...