Location:Redwood City, California, United StatesJob reference:
Mar. 06, 2017
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 Senior Scientist -- DMPK primary duties will encompass working closely with internal departments and external vendors as a subject matter expert in pharmaceutical bioanalysis, pharmacokinetics, modeling and simulation and population PK analysis. You will also characterize drug absorption and disposition and assess the dynamics of drug effect to inform dose selection and go/no-go decisions.
Acerta's Translational Science organization is an efficient and highly collaborative team with responsibility for executing Translational Research programs for clinical and preclinical assets in oncology. Acerta has a fast-paced, interactive, science-driven work environment that requires a willingness to take on new challenges and work independently to achieve corporate goals on an aggressive schedule.
The Senior Scientist -- DMPK is responsible for working as a pharmacokineticist/pharmacometrician to perform pharmacokinetic analysis of data from clinical studies in healthy volunteers and patient studies and provide result summaries for review by the DMPK/clinical pharmacology department. Reviewing of documents for clinical studies such as data review listings, tables and figures listings, statistical analysis plans, bio-analytical workplan, pharmacokinetic analysis plans and pharmacokinetic reports. Contributing to pharmacokinetic/pharmacodynamics (PK/PD) modeling & simulation (M&S) effort by reviewing pharmacokinetic data and identifying issues that need research.
Additionally, the Senior Scientist - DMPK is responsible for working with clinical operations and data management to resolve the issues related to PK data. Working with external vendors such as pharmacokinetic consultants and bio-analytical laboratories to review the project workplan and project contracts. Contributing to clinical study design and implementation of phase 1 and phase 2 studies such as first-in-human trials, dose-escalation trials and drug-drug interaction trials. Participating in clinical study management teams to represent clinical pharmacology group and stay informed of study progress, ongoing PK and/or PD activities in the clinical study, clinical database timelines, CSR timelines etc. Also addressing study team questions related to PK collection or sample shipment, and sample stability. Contributing to program clinical pharmacology strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.
* PhD or PharmD with 2+ years' experience in the pharmaceutical/biotech industry in clinical pharmacokinetics or a related discipline
* MS with 10+ years of experience in DMPK/Clinical pharmacology, pharmacokinetics or a related discipline
* Excellent written and oral communication, interpersonal and problem solving skills
* Can manage multiple projects under tight timelines working independently and collaboratively on teams
* 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
* Resourcefulness, pragmatism, and an independent work ethic
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.