Senior Clinical Pharmacometrician

AstraZeneca - Gaithersburg, MD - Senior Clinical Pharmacology Scientist/Pharmacometrician Location: Gaithersburg, MD Do you have experience in the clinical pharmacometric aspects of drug development, with model-informed drug development? AstraZeneca is seeking a proven Senior Clinical Pharmacometrician that will support small and large molecule projects within Oncology. 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! The Senior ClinicalPharmacometrician primarily will oversee pipeline programs in Oncology life cycle management and direct the clinical pharmacology and pharmacometrics contributions for the assigned projects. You will work collaboratively with other scientists in clinical pharmacology and cross functionally with other groups within AstraZeneca. Activities will include management of clinical pharmacology-related sections of clinical trial protocols and externally-placed research, and representation on related project teams. You will also lead submission teams for the Clinical Pharmacology and Quantitative Pharmacology (CPQP) Department and interact with world health authorities regarding submissions and subsequent queries, and license to operate activities. Model-based analysis in support of Oncology life cycle management projects will also be part of the Associate Director's duties. The position reports to the CPQP Post Market and Lifecycle Management Lead. Responsibilities: Accountable for Clinical Pharmacology and model-informed drug development scientific input into post-approval development plans Represent CPQP on life-cycle management project teams Manage and deliver relevant sections of clinical protocols, externally placed research, academic partnerships, and clinical study reports by working with other scientists in CPQP in a matrix environment Oversee related sections of externally placed clinical trials Lead submission teams and coordinate contributions of functions, including clinical pharmacology, pharmacometrics, statistical sciences, drug metabolism and pharmacokinetics, biopharmaceutics, and bioanalytical/biomarkers Interact with world health authorities for life-cycle management Oncology projects Collaborative review and approval of clinical documents including IB, CSR, PIP, PSP, marketing application sections, health authority briefing documents, and regulatory responses Leads, mentors and coaches staff in CPQP within a matrix environment Coordinates and coauthors external presentations and publications Support evaluation of candidates for in/out-licensing Participates in or lead Department- or Company-level initiatives and/or cross-functional Advisory Teams This position is located in Gaithersburg, MD Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 specialists in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration. ​ The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. Essential requirements: Education Required: Ph.D., PharmD with Industry experience, M.D, or equivalent in a related subject area. Experience Required: At least 8 years in combined industry and/or Regulatory and postdoctoral experience in the field of clinical pharmacology and pharmacometrics. PhD or PharmD with significant clinical research or Regulatory experience in pharmacokinetics, pharmacology or a related field in the biological sciences. Experience in the late stage development of small molecules and/or biologics is highly desirable. Strong understanding of the drug development process at preclinical and clinical stages. ​Experience in the Oncology therapyarea is essential. Experience with health authority interactions and submission of world-wide marketing applications. Broad knowledge of related subject areas including pharmacometrics, statistics, bioanalysis, and translational science. Excellent record of external presentations and publications. Special Skills/Abilities: Experience with Clinical Pharmacology, PK-PD modeling and Pharmacometrics in the Oncology therapy area 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. Job Complexity: Regularly deals with very complex problems and provides creative solutions. Level of Supervision Required: Work is performed with minimal supervision. You'll need real passion for your subject, along with a high level of integrity, plus demonstrated ability to work in multi-disciplinary global teams. Benefits: 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 driven. Why AstraZeneca? 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 cutting edge methods and bringing unexpected teams together. Come and join our journey - Apply today! Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram #clinicalpharmaclogy #pharmacometrician... - Permanent - Full-time

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