Director Clinical Pharmacology & Pharmacometrics (Clinical Pharmacology) at AstraZeneca in Waltham, Massachusetts

Job Description:

Director Clinical Pharmacology & Pharmacometrics (Clinical Pharmacology)


Introduction to role:
Join us as a Director Clinical Pharmacology & Pharmacometrics, a scientific role that works closely with the clinical team to create a clinical pharmacology development program. This role provides differentiated medicine and the right dose to patients. You 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.


Accountabilities:
As a Director, you will be accountable for planning and implementing innovative clinical pharmacology programs with direct value on specific projects including go/no-go decision making. You will be responsible for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at internal (project/governance) and external interactions (investigator meeting/conference/health authorities). You will also contribute to the identification and development of drug-disease models and other modeling approaches to support internal and external decision making in collaboration with internal and external partners (when relevant).


Essential Skills/Experience:
- Expert knowledge of pharmacokinetics and Model-InformedDrug Development (T)
- Expert knowledge in pharmacology, drug targets and core disease areas (T,D)
- Demonstrated broad translational and clinical development expertise and experience exemplified by at least 6 years of drug development experience, with emphasis on Clinical Pharmacology
- Demonstrated ability to identify, develop and execute clinical pharmacology activities at a project level
- Excellent oral and written communication skills
- A demonstrated knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology (T)
- PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required
- Relevant regulatory experience (written/oral)
- Training and experience with PK software (Phoenix, WinNonlin)


Desirable Skills/Experience:
- 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 the field of MBDD (e.g. SIMCYP, R, NONMEM) (T)
- Good leadership capabilities, in particular with regards to influencing skills


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.


Why AstraZeneca?
At AstraZeneca's Biopharmaceuticals R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. We are driven by our shared belief in what science can do, a belief in its potential to redefine what's possible.


Join us and work with curious minds in an inclusive culture where all doors are open, and every voice is heard. From working side-by-side with academia to innovating with biotech, we are forever expanding our horizons. By sharing and increasing our knowledge we are empowered to be the best we can be and accelerate progress.


Ready to make a difference? Apply today and join us in our mission to push the boundaries of science to deliver life-changing medicines!


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.