Job Description The Scientist II/Senior Scientist will be responsible for the design, execution, interpretation and reporting of clinical pharmacology and clinical/nonclinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This includes the assessment of PK/PD relationships of recombinant protein and small molecule drug candidates that are situated throughout all stages of development (Phase 0-IV). The individual will assess and recommend dose levels and regimens for molecules in Phase 0-IV clinical development (including new indications for existing therapeutics) by working in close partnership with medical directors, clinical scientists, biostatisticians, bioanalytical research scientists, pharmacologists and toxicologists, , formulation and process scientists, and project teams. This assessment will require modeling, simulations and predictions of PK and PD, and make recommendations on dose regimen for drug candidates in clinical development. Population PK/PD and exposure-response analysis of drug candidates will be conducted as the programs progresses in clinical development.. The individual will be responsible for the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams, external collaborators, US and ex-US regulatory authorities and the scientific community. RESPONSIBILITIES · Design and interpret PK/PD studies in support of molecules in clinical and nonclinical development. · Model, simulate and predict nonclinical and clinical data to drive decisions on dose and frequency of dosing · Perform population PK analyses on drug candidates as they progress through clinical development · Provide expert PK/PD advice to cross-function project teams · Interact with pharmacologists, toxicologists, medical directors and regulatory affairs personnel within BioMarin for the timely completion of clinical and nonclinical studies and regulatory filings. · Represent the Pharmacological Sciences Department on multi-disciplinary drug development teams and lead departmental sub-teams. · Interact with external collaborators, multi-company project teams regarding and outside contractors · Write reports, sections to INDs, NDAs, etc. and publish findings at the appropriate time EDUCATION Ph.D. in a pharmaceutical science or related field. EXPERIENCE · At least 2 years for Scientist II or 5 years for Sr. Scientist of industry experience. · Required: Strong background in quantitative clinical pharmacology analysis, pharmacokinetics and/or statistics with extensive knowledge of drug development process · Required: Extensive hands-on experience with population PK/PD and exposure-response analysis using NONMEM/R/SPLUS software in clinical drug development · Required: Extensive hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin · Required: Excellent writing and verbal communication skills both cross-functionally within BioMarin as well as outside to various regulatory agencies. · Required: Hands-on experience with preparing clinical pharmacology/PK/PD related sections in regulatory submissions (i.e., IB, IND, NDA, MAA, BLA). · Required: Extensive clinical pharmacology and clinical/nonclinical PK/PD study design, implementation and interpretation; experience in modeling and simulation · Required: Experience with GLP procedures and documentation or equivalent familiarity with FDA guidance’s. · Preferred: In vitro/in vivo ADME experience · Preferred: Pharmacokinetic experience with biologics and the associated immunogenicity issues is a plus.
To apply: link to job posting: http://ch.tbe.taleo.net/CH04/ats/careers/requisition.jsp?org=BMRN&cws=1&rid=7464 Questions please contact: Yvonne Gwinnell Sr. Recruiter Work: 415-506-3241 Email: [email protected]<mailto:[email protected]> -- Yulan Qi Senior Scientist I, PK/PD BioMarin Pharmaceutical Inc. 105 Digital Dr. Novato CA 94949 Tel: 415-506-3511 Cell: 415-827-9107 Email: [email protected] This message is intended only for the confidential use of the intended recipient(s). If you have received this communication in error, please notify the sender by reply e-mail, and delete the original message and any attachments. Any unauthorized disclosure, copying, or distribution of this message (including the attachments), or the taking of any action based on it, is strictly prohibited.
