Location:Redwood City, California, United StatesJob reference:
Oct. 14, 2016
Acerta Pharma is a leader in the field of covalent binding technology and is applying this technology to create novel, highly selective therapies for cancer. In February 2016, AstraZeneca acquired a majority share of Acerta Pharma via a USD $4 billion investment and is a committed partner to the development of these innovative drug candidates.
Acalabrutinib is Acerta's lead program which was developed based on our discovery efforts. It is an investigational covalent Bruton tyrosine kinase (BTK) inhibitor currently under investigation in multiple Phase 3 clinical trials. The clinical program includes over 20 trials in hematologic malignancies and solid tumors. Over 1,800 patients have participated in these trials to date.
The Clinical Pharmacologist will work closely with Translational Sciences, Clinical Development, Clinical Biometrics, Clinical Data Management and Clinical Operations staff and external vendors as a subject matter expert in Clinical Pharmacology in support of Acerta clinical and nonclinical development programs. In addition, you will apply pharmacokinetic/pharmacodynamics (PK/PD) and modeling & simulation (M&S) approaches to characterize drug absorption and disposition and assess the dynamics of drug effect to inform drug candidate selection, dose selection and go/no-go decisions, and work with preclinical and clinical CROs and company scientists to conduct and monitor clinical and nonclinical studies, maintain study records and ensure study completion along program timelines. Finally, you will contribute to program clinical pharmacology strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.
* PhD or PharmD with two or more years' experience in the pharmaceutical/biotech industry in clinical pharmacokinetics 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
* Experience in oncology and immuno-oncology is beneficial
* Resourcefulness, pragmatism, and an independent work ethic
* Can manage multiple projects under tight timelines working independently and collaboratively on teams
Next Steps -- Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.