MedImmune Clinical Pharmacokineticist in South San Francisco, California
South San Francisco,California,United States
Job reference: R-027586
Posted date: May. 07, 2018
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. We are seeking a Clinical Pharmacokineticist to work in our South San Francisco office.
The pharmacokinetist functions as the Global PKPD & Bioanalysis project leader and team representative for biotherapeutic products at various stages of research and clinical development. The scientist will be responsible for all aspects of PK-related support for biotherapeutic products, including design of studies, analysis and preparation of toxicokinetic reports, clinical PK sub-reports, pre-clinical and clinical protocols; perform non-compartmental PK analysis, dataset preparation for NONMEM analysis, simple NONMEM analysis and reporting of data, and communication of data in regulatory documents and meetings. The scientist is also expected to use advanced PKPD modeling tools to support the therapeutic target evaluation, the design of in vivo animal efficacy studies, starting dose recommendation for first-in-human studies, the assessment of clinical PKPD data, and the optimal design of clinical trials.
Major Duties and Responsibilities:
Represent Global PKPD & Bioanalysis on cross-functional project teams involved in the nonclinical and clinical development of biotherapeutics.
Plan, coordinate, initiate, and monitor outsourced nonclinical pharmacokinetic (PK) and pharmacodynamic (PD) studies; Prepare PK/PD reports for outsourced studies; review and finalize study reports
Collaborate with toxicologists on the design and reporting of nonclinical safety studies; prepare TK reports; Comply with GLP regulations for GLP studies
Prepare PK/PD and bioanalytical subr-reports for outsourced studies; review and finalize study reports
Collaborate with biostatisticians, clinicians and clinical operation managers for the optimal design of Phase I-IV studies; contribute to the clinical study protocols and reports;
Use translational simulations to project the human PK/PD for the starting-dose selection for first-in-human studies. Perform population- and/or mechanism-based modeling to characterize the PK and PD of candidate drugs. Perform clinical trial simulations to support development decisions.
Prepare relevant sections of regulatory documents; participate in regulatory meetings if requested.
Present and report data in approved external meetings and publications
Education & Experience:
Bachelor's degree in pharmaceutical sciences, biological sciences, chemistry or related field with 5-10 years of experience; OR
Master’s Degree in pharmaceutical sciences, biological sciences, chemistry or related field with 2-8 years of experience; OR
Pharm D with clinical pharmacology fellowship training or relevant industry experience (3-5 years)
PhD in pharmaceutical sciences or a related field (0-3 years of experience)
Strong analytical and technical writing skills are required for this position. Good communication/organization skills, a full understanding of basic PK concepts, and familiarity with WinNonlin and GLP regulations are essential. Prior modeling/simulation experience and knowledge of Splus/R and SAS/JMP are highly desirable.
Familiarity with standard noncompartmental data analysis software. Experience with standard population modeling and associated software (NONMEM, R/Splus, SAS) is highly desirable. Prior training in statistics, numerical method and computer programming is a plus.
Good communication skills and ability to work in a cross-functional team environment; Experience in regulatory filings and knowledge of GLP regulation are desired
Function with minimal supervision