Reports To (Position): Director/Senior Director
Location: South San Francisco, CA
Department Name: Quantitative Clinical Pharmacology
HR Designations: Pay Status – Exempt
Objective of Position
Seeking a passionate Scientist who wishes to merge disciplines of Clinical Pharmacology, Quantitative Pharmacology, and Precision Medicine to support early through late-stage oncology drug development as part of Acerta Research and Development (aRED). Acerta Pharma (a member of the AstraZeneca Group) has a fast-paced, interactive, science-driven work environment that will require a willingness to conquer challenges in hematology/oncology drug development and to work cross-functionally to achieve corporate goals.
Essential Duties/ Responsibilities
- Work collaboratively with Translational Sciences, Technology Innovation and Delivery, DMPK, Clinical Biostats, Clinical Development, Drug Safety, Project Teams and Program Management as a subject matter expert in quantitative clinical pharmacology (QCP)
- Apply hands-on expertise in non-compartmental pharmacokinetic analysis, oncology pharmacokinetic/pharmacodynamics (PK/PD), and pharmacometrics to characterize drug disposition and assess the dynamics of drug response to inform dose selection, schedule, combination, and go/no-go decisions
- Work with global drug development team members to design, conduct, analyze, and integrate date from clinical 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
- Demonstrate excellence in science (publications and grantsmanship) with exposure to drug development (preferred)
- Ability to manage projects under tight timelines is critical. Must possess ability to independently and actively initiate, build, adapt, and maintain collaborative scientific and programmatic relationships within and across Acerta and AZ teams
- Broad understanding of foundations of pharmaceutical sciences as they apply to: drug absorption, drug metabolism, drug-drug interactions, pharmacogenetics, PBPK modeling, biomarkers, diagnostics, quantitative systems pharmacology, biostatistics, and regulated bioanalysis
- Desired to have experience in authoring and/or reviewing clinical pharmacology/PK/PD reports and regulatory submissions
- Keen awareness to uphold local and global laws and best practices (ie General Data Protection Regulation (GDPR)), Code of Ethics, and awareness of CFR and global regulatory requirements governing drug development
- Resourcefulness, pragmatism, creativity and a strong independent work ethic is a must
- PhD or PharmD with 0 to 3+ years post-doctoral experience as a Clinical Pharmacologist/ Pharmacometrician in the pharmaceutical industry or related field.
- 5-10+ years’ relevant experience post Baccalaureate or Masters degree
- Hands-on experience with NCA and modeling and simulation (knowledge of WinNonlin®, NONMEM®, R/S+, SAS®, MATLAB® or similar modeling software)
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.