Director Clinical Pharmacologist/Pharmacometrician
Are you looking for a hybrid role in clinical pharmacology and pharmacometrics? Are you interested in working within a large international global team?
At AstraZeneca, we win through science, it’s at the heart of our every success. That science is only possible when we all work together – we’ll always make sure you’re clear about how your role is connected to our wider mission to really show what science can do!
Position Summary and Responsibilities
You will define a fit-for-purpose program to understand the Clinical Pharmacology aspects of the drugs and to meet regulatory requirements, consistent with the projects milestones and timelines across all phase in development. You will be accountable for Clinical Pharmacology input to Study Designs/Protocols for studies as part of development program, and be accountable for the design and delivery of clinical pharmacology studies to projects and acts as the Quantitative Clinical Pharmacology interface with the projects organization.
You will integrate the Clinical Pharmacology knowledge and ensure that it meets all relevant regulatory standards to support the appropriate use of the drug in the target population. You will evaluate and interpret Clinical Pharmacology data to prepare for internal governance bodies, interpret and prepare the Clinical Pharmacology part of project and regulatory documents (e.g. IND, IMPD, IB, NDA BLA CTD), defend the clinical pharmacology package in interactions with Regulatory Authorities, and represent the discipline in Due Diligence and in-licensing activities.
Finally, you will be jointly accountable with the pharmacometrician for providing a scientific justification for the dose selection, provide scientific training in Clinical Pharmacokinetics and clinical pharmacology and support internal review processes, collaborate with Pharmacometricians in the modeling of emerging PK/PD data, publish scientific papers describing the PK and clinical pharmacology of their project, communicate Clinical Pharmacology perspective, results and implications to teams and work collaboratively with the DMPK Functional Project Leaders to ensure an adequate forward and back translation of Clinical PK/ADME data.
• PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required
• Broad background and a comprehensive understanding of Clinical Pharmacology aspects of drug development
• Significant experience in pharmaceutical R&D with at least seven years’ experience
• Expert knowledge of pharmacokinetics and Model-Based Drug Development
• Expert knowledge of drug absorption, metabolism and disposition
• Biological understanding of drug absorption and disposition
• Excellent oral and written communication skills
• Demonstration of significant international drug regulatory experience
• External scientific expertise demonstrated by scientific publishing in the field of clinical pharmacology
• Early and late phase clinical development experience
• Experience in Oncology
• Experience with small molecules, biologics, or other therapeutic modalities (e.g. antibody drug conjugates, cell therapy etc.)
Job Complexity: Regularly deals with very complex problems and provides creative solutions.
Level of Supervision Required: Independent contributor with minimal work being performed under supervision of senior CPQP members.
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.
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.
Come and join our journey - Apply today!
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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.
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 authorisation and employment eligibility verification requirements.