REPORTS TO (POSITION): Senior Director
LOCATION: South San Francisco, CA
DEPARTMENT NAME: Quantitative Clinical Pharmacology
HR DESIGNATIONS: PAY STATUS – EXEMPT
Objective of Position
The Principal Scientist/Associate Director/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 proactively lead on new challenges in hematology/oncology drug development 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 subject matter expert in oncology quantitative clinical pharmacology and pharmacometric modeling and simulation.
- Apply hands on expertise in non-compartmental pharmacokinetic analysis, oncology pharmacokinetic/pharmacodynamics (PK/PD) and pharmacometric modeling & simulation (M&S) to characterize drug absorption and disposition and assess the dynamics of drug effect to inform dose selection and go/no-go decisions.
- Work with CROs and company scientists to conduct and monitor clinical and nonclinical studies, maintain study records and ensure study completion along program timelines.
- Work effectively as the clinical pharmacology representative on study teams.
- Contribute dynamically to program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.
- Excellent written and oral communication, with high level interpersonal and problem-solving skills.
- Experience in oncology and immuno-oncology model development and application is essential, experience in translational aspects of hematology/oncology drug development is preferred.
- Can manage multiple projects under tight timelines. The ability to independently and actively initiate, build and maintain, collaborative scientific relationships within and across Acerta and AZ teams is essential.
- Experience managing data transfer processes and timelines.
- A solid understanding of foundations of regulated bioanalysis, drug metabolism, drug interactions, PBPK modeling, biomarkers and biostatistics.
- Experience writing clinical pharmacology/pharmacokinetic/pharmacometric reports and regulatory submissions and performing quality control.
- Solid knowledge of regulatory requirements governing drug development.
- Resourcefulness, pragmatism, creativity and an independent work ethic.
- PhD or PharmD with 3+ years' experience as a Clinical Pharmacologist/Pharmacometrician in the pharmaceutical industry or related field.
- 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 and substantial experience building NONMEM datasets.
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.