POSITION OBJECTIVE: Perform and lead pharmacokinetic (PK) and/or pharmacodynamic (PD) modeling and analysis of Athenex’s drug pipeline to support nonclinical, clinical and clinical pharmacology development. Provide expertise and interpretation of PK/PD results to Clinical, Nonclinical, and Biostatistics teams for drugs ranging from early clinical development to Phase III.
A candidate has already been identified but all qualified applicants are encouraged to apply.
Essential Job Functions
The Clinical Pharmacology, PK/PD Scientist will apply pharmacokinetic/pharmacodynamics and modeling & simulation (M&S) approaches to characterize drug absorption and disposition, and assess the dynamics of drug effect to inform drug candidate selection and dose selections., The incumbent will work with preclinical and clinical internal teams and external CROs to conduct and monitor clinical and nonclinical studies, maintain study records and ensure study completion along program timelines. Finally, the incumbent will contribute to program clinical pharmacology strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.
Duties & Responsibilities
· Perform PK analysis of ongoing and completed studies using noncompartmental and/or compartmental approaches.
· Responsible for conducting, summarizing and interpreting results of pharmacokinetic/pharmacodynamic analyses with respect to their impact on development and clinical use of drugs.
· Responsible for preparing documentation intended for regulatory submissions, including the relevant sections of INDs and NDAs.
· Interface with preclinical and clinical groups to establish project objectives and ensure they are achieved to support clinical development.
· During the pre-clinical stages of drug development works with Research to ensure that sufficient preclinical PK-PD knowledge exists to underwrite safe human administration.
· Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology knowledge in terms of both medical background and clinical trial design.
Required Education & Qualifications
· PhD or PharmD with 0-5 years of experience in the pharmaceutical/biotech industry in pharmaceutical sciences, biostatistics, pharmacy or a related discipline.
· Excellent written and oral communication, interpersonal and problem solving skills.
· Extensive hands-on experience and detailed knowledge of PK software (e.g. WinNonlin, ADAPT II, Berkeley Madonna, NONMEM, etc.).
· Experience with statistical analysis software (e.g. R, SAS, etc.) and scientific graphing and analysis software (Sigma plot, GraphPad, etc.).
· Strong understanding of the drug development process with experience managing data, writing clinical pharmacology/pharmacokinetic reports and regulatory submissions and performing quality control.
· Understanding of regulatory guidance.
o Experience in oncology and immuno-oncology is beneficial
o Resourcefulness, pragmatism, and an independent work ethic
o Can manage multiple projects under tight timelines working independently and collaboratively on teams
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.