- Experience Level
- Experienced (non-manager)
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost 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 exceptional skills with those of people from all over the globe!
We pride ourselves on making sure that each decision we make puts patient needs first! This mentality means that our people have permission to take the more unusual path. If they can think of a better, smarter way in which we can change lives through science, at we want to hear it.
As the Principal Clinical Pharmacologist/Pharmacometrician, you will coordinate Oncology programs in clinical development and life cycle management and direct the clinical pharmacology and pharmacometrics contributions for the assigned projects. You will work collaboratively and cross functionally with other groups within AstraZeneca. Activities will include management of clinical pharmacology related sections of clinical trial protocols, study reports, filing documentation and externally-sponsored research, and representation on related project teams. You will also participate or lead submission teams and interact with world health authorities regarding submissions and subsequent queries.
- Represent CPQP on late-stage and/or life-cycle management project teams
- Lead and deliver relevant sections of clinical protocols, externally sponsored research, and clinical study reports by working with other scientists in clinical pharmacology in a matrix environment
- Supervise related sections of externally sponsored clinical trials
- Lead submission teams and coordinate contributions of functions, including clinical pharmacology, pharmacometrics, statistical sciences, drug metabolism and pharmacokinetics, biopharmaceutics, and bioanalytical
- Interact with world health authorities on marketing application-related meetings
- Collaborative review and approval of clinical documents including IB, CSR, PIP, PSP, marketing application sections, health authority briefing documents, and regulatory responses
- Coordinates and coauthors external presentations and publications
- Participates in Department-level initiatives
Education and Experience Required:
- Ph.D., M.D. in pharmacokinetics, pharmacology or a related field in the biological sciences.
- At least four years in combined industry and/or regulatory and postdoctoral experience in the field of clinical pharmacology and pharmacometrics.
- Experience in the early and late stage development of small molecules and/or biologics is highly desirable. Good understanding of the drug development process at preclinical and clinical stages. Experience across disease areas is desirable. Experience with health authority interactions and submission of world-wide marketing applications. Knowledge of related fields including statistics, bioanalysis, and translational science is highly desirable. A record of external presentations and publications is highly desirable.
- Experience with PK-PD modeling and pharmacometrics
- Teammate works with others respectfully and cordially.
- The ability to adapt, work through conflicts, and persuasively influence outcomes.
- Effectively cope with change and is comfortable changing direction and acting without complete information.
- Demonstrated ability to develop and present sound proposals and recommendations and influence and motivate others to achieve objectives.
- Ability to develop and deliver effective presentations and written/oral communications.
- Thrives in a fast-paced business environment.
The AstraZeneca Gaithersburg campus employs more than 3,500 specialists in our field and is only a short drive from Washington, DC. This green, sustainable, modern, vibrant scientific campus is where we host some of the most cutting-edge technology and lab spaces. Newly designed, state of the art research spaces and open seating floor plans are just a couple of ways we work cross functionally and collaboratively.
The Gaithersburg campus also provides an award winning café, free garage parking with electric car charging stations, bike racks, free fitness center to include classed and personal training game rooms, outdoor patio, bocce ball court, arcade games and game tables, recharge Pod's, library, walking trails, onsite dry cleaning pickup, haircutting service, health and wellness center, starbucks café, and much more!
AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It's our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees' varying needs, and offers valuable choices.
Are you already imagining yourself joining our team? Apply today!
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.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential.
Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.
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