Principal Investigator/Senior Scientist, Drug Metabolism Pharmacokinetics (DMPK)

 Principal Investigator/Senior Scientist, Drug Metabolism Pharmacokinetics (DMPK)

Job Code: DMRHPI040108

We are Archemix Corp., a vibrant growing biotech organization where every day matters. Fueled by innovation and guided by compassion, we create aptamer therapeutics that improve the quality of human life. 

Based in Kendall Square in Cambridge, MA, we are focused on discovering, developing, and commercializing aptamer therapeutics.  Currently, Archemix and its licensees are evaluating five different aptamer product candidates in human clinical trials. We have numerous licensing partnerships with well established and scientifically respected biotechnology and pharmaceutical companies. At Archemix, we are developing aptamers as an exciting new class of oligonucleotide-based therapeutics.

Overview: The Drug Metabolism and Pharmacokinetics (DMPK) department at Archemix is seeking a highly motivated individual with proven abilities who will be involved in the design, execution, supervision, interpretation and communication of PK/ADME and bioanalytical studies. These studies will enable the optimization and selection of aptamer for drug development candidates, and provide assessment of their PK/ADME characteristics to support drug development.

Reports To: Director, DMPK

Direct Reports: 2, possibly 3 direct reports

Responsibilities:

· Provide expert level guidance and work independently as the study director in the design, implementation, data analysis and interpretation of PK/ADME, PK/PD and bioanalytical studies

· Perform and implement both in vitro and in vivo experiments to acquire aptamer PK, PK/PD and ADME properties.

· Perform PK and PK/PD data analysis, modeling, simulation and prediction to provide human dose projection and exposure based on extrapolation from in vivo or in vitro data.

· Represent DMPK in interdisciplinary project teams and provide guidance to implement strategies to enable programs to select drug candidates for nomination into development. 

Requirements:This position will require knowledge of Pharmacokinetic/Pharmacodynamic modeling to facilitate prediction of the exposure required in humans. The candidate must be able to work both independently and successfully collaborate internally in  a matrix team environment, and externally with partner companiesHe /she must be able to write reports for IND and NDA filings including the writing of SOP’s. The position requires the mentoring /leading of lesser experienced scientists and staffHe/she must be able to monitor internal and external PK/ADME and Bioanalytical non-GLP and GLP studies.The successful candidate will have a PhD degree in Pharmacokinetics, Drug Metabolism, or related field with a minimum of  4+years of industrial experience in the evaluation of oligonucleotide-based or small molecule therapeuticsThe ability to demonstrate excellent knowledge in PK and drug metabolism principles is a must, as is a working knowledge of PK/ADME science as it relates to drug discovery, development, delivery or general disposition.Experience in PK, and PK/PD data analysis including PK modeling, simulation and prediction is requiredFamiliarity with various PK software packages, such as WinNonLin, ADAPT, SAAMI and NONMEM is necessary. The candidate must have working experience and proficiency with HPLC and LCMS instrumentation.  The candidate must be familiar with laboratory techniques such as in vitro/in vivo metabolism and PK experiments, analysis of drugs and metabolites in biological fluids. 

Preferences:

·  Prior experience with writing IND’s, BLA’s and/or NDA’s is  highly desired 

·  The candidate should be organized, highly motivated, and have excellent written and oral communication skills. He/she should be detail oriented with the ability to multitask. 

PLEASE APPLY ON LINE BY VISITING OUR WEBSITE at www.archemix.com

 Archemix is an equal opportunity employer, welcoming diversity in our workforce.