Location: Waltham, MA (USA)
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!
The Clinical Pharmacologist/Pharmacometrician primarily will be responsible for the study related program activities in Oncology drug development and conduct the clinical pharmacology and pharmacometrics contributions for the assigned projects. The clinical pharmacologist/pharmacometrician will work collaboratively with other scientists in clinical pharmacology and cross functionally with other groups within AstraZeneca. Activities will include understand and develop clinical pharmacology-related sections of clinical trial protocols and externally-placed research, and representation on related project teams. The incumbent will also conduct submission related activities working with the project leads of the Clinical Pharmacology and Quantitative Pharmacology (CPQP) Department and interact with world health authorities regarding submissions and subsequent queries, and license to operate activities. Conducting hands-on Model-based analysis in support of Oncology projects will also be part of the incumbent's duties.
- Accountable for the conduct of Clinical Pharmacology and model-informed drug development scientific activities and help in input into clinical development plans
- Represent CPQP on project teams
- Conduct, manage and deliver relevant sections of clinical protocols, externally placed research, academic partnerships, and clinical study reports by working with the CPQP project leads and/or other scientists in CPQP in a matrix environment
- Oversee related sections of externally placed clinical trials
- Conduct submission related activities and manage contributions of functions, including clinical pharmacology, pharmacometrics, statistical sciences, drug metabolism and pharmacokinetics, biopharmaceutics, and bioanalytical/biomarkers
- Interact with world health authorities (with experience) for Oncology projects
- Collaborative conduct, writing, review and approval of clinical documents including IB, CSR, PIP, PSP, marketing application sections, health authority briefing documents, and regulatory responses
- Conducts, coordinates and coauthors external presentations and publications
- Participates in Department level initiatives and/or cross-functional teams
Ph.D., PharmD with Industry experience, M.D or equivalent in a related discipline.Experience Required:
0 -7 yrs experience considered 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. Title commensurate with experience
Experience in the oncology drug development of small molecules and/or biologics is highly desirable. Fundamental understanding of the drug development process at preclinical and clinical stages. Fundamental knowledge of related disciplines including pharmacometrics, statistics, bioanalysis, and translational science. Adequate record of external presentations and publications.Special Skills/Abilities
- Experience with Clinical Pharmacology, PK-PD modeling and Pharmacometrics in the Oncology therapy area
- Team player works with others respectfully and cordially.
This position is located in Waltham, MA
- The ability to adapt, work through conflicts, and persuasively influence outcomes.
- Effectively cope with change and is comfortable changing direction and acting withoutcomplete information.
- 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 R&D Waltham site is dedicated to cutting edge drug discovery, the facility is now a dynamic center where scientists from a variety of companies come together to share ideas and push the boundaries of science, with more buzz and more people than ever before!
Th Waltham site is one of three AstraZeneca R&D sites to be transformed into a BioHub, along with Molndal, Sweden and Alderley Park, UK, where AstraZeneca researchers are working side-by-side with scientists from academic institutions to make strides in scientific discovery. AstraZeneca believes in what science can do and values the partnerships that contribute to the discoveries that ultimately help patients.More information
Please contact: Karthick Vishwanathan at Karthick.email@example.comBenefits:
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.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 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!Where can I find out more?
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#pharmacometrics #oncology #pharmacometricianAstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.
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