Sr. Clinical Pharmacologist (DMPK)
The Sr Clinical Pharmacologist (DMPK)
This selection will bring experience in oncology quantitative pharmacology and pharmacometric modeling and simulation to AstraZeneca’s project teams. Acerta Pharma (a member of the AstraZeneca Group) has a fast-paced, interactive, science-driven work environment that will require a willingness to lead on new challenges and to work cross-functionally to achieve corporate goals.
Essential Duties/ Responsibilities
- Work closely with AstraZeneca Early Development as a leader and subject matter expert in oncology quantitative pharmacology and pharmacometric modeling and simulation.
- Apply pharmacokinetic/pharmacodynamics (PK/PD) and pharmacometric modeling & simulation (M&S) approaches to characterize drug absorption and disposition and assess the dynamics of drug effect to inform dose selection 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.
- Contribute to program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.
- Excellent written and oral communication, interpersonal and problem-solving skills.
- Experience in Hematology, oncology or immuno-oncology drug development is desired
- Ability to work across functions such as, clinical, regulatory, statistics, and clinical operations.
- Can work on multiple project under tight timelines working both independently and collaboratively on teams.
- Experience writing clinical pharmacology/pharmacokinetic/pharmacometric reports and regulatory submissions and performing quality control desired.
- Knowledge of regulatory requirements governing drug development desired.
- Resourcefulness, pragmatism, creativity and an independent work ethic.
- PhD or PharmD preferred with 2+ years' experience (depending on level) as a Clinical Pharmacologist/Pharmacometrician in the pharmaceutical industry or related field/experience. Experience in drug metabolism (DMPK) a plus.
- Experience in noncompartmental analysis and pharmacometric modeling and simulation including use of WINNONLIN and NONMEM or similar statistical modeling software desired.
- Knowledge of R, SAS, MATLAB or similar modeling software with applications of quantitative pharmacology principles desired.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.