Director, Quantitative Clinical Pharmacology
Department Name: Quantitative Clinical Pharmacology
Objective of Position
The Director, Clinical Pharmacology and Pharmacometrics will bring extensive experience in oncology quantitative pharmacology and pharmacometric modeling and simulation to Acerta project teams. Acerta Pharma (a member of the AstraZeneca Group) has a fast-paced, interactive, science-driven work environment that will require a willingness to lead on new challenges and to work cross-functionally to achieve corporate goals.
Essential Duties/ Responsibilities
- Work closely with Acerta Research and Early Development, Acerta Development, and with AstraZeneca as a leader and subject matter expert in oncology quantitative pharmacology and pharmacometric modeling and simulation.
- Apply pharmacokinetic/pharmacodynamics (PK/PD) and pharmacometric modeling & simulation (M&S) approaches to characterize drug absorption and disposition and assess the dynamics of drug effect to inform dose selection and go/no-go decisions.
- Work with preclinical and clinical CROs and company scientists to conduct and monitor clinical and preclinical studies, maintain study records and ensure study completion along program timelines.
- Contribute to program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.
- Excellent written and oral communication, interpersonal and problem-solving skills.
- Experience in oncology and immuno-oncology model development is essential, experience in translational aspects of hematology/oncology drug development is preferred.
- Ability to inspire and lead a group of pharmacometricians and clinical pharmacologists.
- Can manage multiple projects under tight timelines working both independently and collaboratively on teams.
- Experience managing data transfer processes and timelines.
- Experience writing clinical pharmacology/pharmacokinetic/pharmacometric reports and regulatory submissions and performing quality control.
- Knowledge of regulatory requirements governing drug development.
- Resourcefulness, pragmatism, creativity and an independent work ethic.
- PhD or PharmD with 10+ years' experience as a Clinical Pharmacologist/Pharmacometrician in the pharmaceutical industry or related field/experience.
- Extensive experience in noncompartmental analysis and pharmacometric modeling and simulation including use of WINNONLIN and NONMEM or similar statistical modeling software.
- Knowledge of R, SAS, MATLAB or similar modeling software with applications of quantitative pharmacology principles.
To apply for this position, please send your resume to email@example.com
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.
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