Senior Clinical Pharmacologist
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 Senior Clinical Pharmacologist you will work closely with the clinical team to create clinical-pharmacology development program to provide differentiated medicine and the right dose to patients.
The Senior Clinical Pharmacologist will apply state-of-the-art Clinical Pharmacology and Model-informed Drug Development (MIDD) approaches to influence study designs and internal/external decision making at the project level. You will support global initiatives to develop the clinical pharmacology discipline and at times mentor junior staff. You will work closely with project colleagues to ensure appropriate implementation of state-of-the-art clinical pharmacology program based on MIDD.
Accountable for planning and executin state-of-the-art clinical pharmacology program with direct value on specific projects including go/no go decision making
Accountable for data integration, analysis, interpretation, and reporting of clinical pharmacology results at internal (project/governance) and external interactions (investigator meeting/conference/health authorities)
Jointly accountable with the pharmacometrician for providing a scientific justification for the dose selection
Contribution to the identification and development of drug-disease models and other modelling approaches to support internal and external decision making in collaboration with internal and external partners (when relevant)
Support evaluation of candidates for in/out-licensing
Contribute to internal initiatives to develop the clinical pharmacology discipline including its processes
Participation in and accountability for peer review of ongoing activities, reports and presentations
Supervision of clinical pharmacology work performed by external contractors and more junior clinical pharmacologists, graduate students and post-docs
Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance's
PhD degree preferred; M.Sc. / Pharm.D. required
Demonstrated broad translational and clinical development expertise and experience exemplified by at least 6 years of drug development experience, with emphasis on Clinical Pharmacology
Advanced knowledge of pharmacokinetics and Model-Informed Drug Development (T)
Advanced knowledge in pharmacology, drug targets and core disease areas (T,D)
Demonstrated ability to identify, develop and execute clinical- pharmacology activities at a project level
Excellent oral and written communication skills
Proven knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology (T)
Relevant regulatory experience (written/oral)
Training and experience with PK software (Phoenix, WinNonlin
International scientific reputation gained from scientific publishing in the field of DMPK/Clinical Pharmacology
Experience in early and late-stage drug development
Experience with relevant software and tools within MBDD (e.g. SIMCYP, R, NONMEM) (T)
Good leadership capabilities, with regards to influencing skill
This position is in Gaithersburg, MD
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, offers valuable choices, and is highly competitive.
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 recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next?
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