Location:Redwood City, United StatesJob reference:
Sep. 14, 2016
Acerta Pharma was established in 2013 with a mission to discover and develop novel targeted molecules with the potential to improve patients' lives. At the core of our vision is a foundation based on cutting edge technologies, which enable the development of specific and selective drug candidates. Acerta's innovations translate to more effective and less toxic prospective therapies. As a member of the AstraZeneca group, Acerta is well positioned to rapidly achieve its first of hopefully several drug approvals to come.
Main Duties and Responsibilities:
You will work closely with Translational Sciences, Clinical Development, Clinical Biometrics, Clinical Operations staff and external vendors in pharmaceutical bioanalysis, in vitro and in vivo drug metabolism, preclinical and clinical pharmacokinetics and the design and conduct of clinical drug interaction and human [14C] metabolism studies.
In addition, you will apply in vitro and in vivo approaches to characterize drug ADME/PK and drug interactions to inform drug label development and go/no-go decisions, work with preclinical and clinical CROs and company scientists to conduct and monitor clinical and preclinical studies, maintain study records and ensure study completion along program timelines, and contribute to program DMPK strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.
* PhD or PharmD with experience as a DMPK scientist in the pharmaceutical industry
* BS or MS with five or more years' experience working as a DMPK scientist in the pharmaceutical industry
* Experience in Non Compartmental Analysis PK analysis using WINNONLIN.
* Experience managing data transfer processes and timelines
* Experience writing DMPK/clinical pharmacology/pharmacokinetic reports and regulatory submissions and performing quality control
* Working knowledge of regulatory requirements governing drug development activities
* Excellent written and oral communication, interpersonal and problem solving skills
* Can manage multiple projects under tight timelines working independently and collaboratively on teams
* 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