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Bioanalytical Study Director

Drug Metabolism/Pharmacokinetics

SUMMARY:

The Study Director is responsible for the execution of bioanalytical protocols that meet stated timelines and quality standards in a GLP environment. These bioanalytical studies are performed at Accium in support of a Sponsor’s Phase 1 clinical study, including pharmacokinetics, absolute bioavailability, metabolite profiling, mass balance and microdosing studies. Clinical studies are conducted using compounds that are lightly labeled with 14C isotope. These Phase 1 studies are typically performed in 6-18 healthy volunteers over several days at a single clinical site. The clinic submits the samples to Accium BioSciences for processing and quantitation on Accium’s 0.5 mV Accelerator Mass Spectrometer (AMS), an ultra-sensitive mass spectrometer capable of quantifying drugs present at attomole (10^-18 M) concentration. The Study Director is the primary point of contact with the Sponsor, initially helping to conceptualize the study, writing the Bioanalytical Protocol, scheduling internal resources, training and managing laboratory staff and then overseeing the proper conduct of the study as described in the protocol. The Study Director works in the front end of the process where sample preparation, HPLC and processing are performed prior to transfer to Graphitization and AMS Laboratories. The position reports to the President and Scientific Director.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Communicate with pharmaceutical Sponsors and help develop and a bioanalytical protocol
Write the Bioanalytical Protocol, provide training and obtain approval by
Help generate cost and time estimates for the study
Manage resources, equipment and staff to meet stated timelines
Oversee the receiving and documentation of study samples submitted to Accium for analysis from outside clinics (typically 100-250 samples per study)
Schedule day-to-day laboratory activities and, with the aid of laboratory staff, perform all laboratory procedures, including documentation compliance with Quality Standards in a GLP environment
Ensure laboratory equipment is being maintained and/or calibrated according to SOPs
Manage consumable and supply inventory
Primary person responsible for assembling all study data and transferring results to Sponsor as described in Study Protocol
Closely co-ordinate activities with Graphitization Laboratory, AMS Laboratory, Purchasing, Senior Management, Quality Assurance and Sponsor.
Participate in the evaluation, training and refining of departmental SOPs and guidelines, and the development of standard reports, templates and forms.
Problem-solve logistical issues related to Project Management

Requirements:

Ph.D. in chemistry, analytical chemistry or similar discipline
6+ years laboratory experience
Management experience overseeing small team
GLP or GMP experience
Strong oral and written communicator
Time-management skills
Must work methodically on time-critical study elements

About Accium BioSciences:

Accium BioSciences is a privately-held contract research company offering ultrasensitive bioanalytical services in support of early-phase clinical trials. The company’s clients are primarily large pharmaceutical companies investigating the bioavailability, pharmacokinetics and metabolism (PK/ADME) of new chemical entities. Our services are based on accelerator mass spectrometry (AMS), a detection platform for quantifying drugs and metabolites in clinical samples with unprecedented sensitivity. In April 2006, Accium BioSciences launched the first US-based AMS Facility in the U.S dedicated to pharmaceutical services. The company is based in Seattle, Washington.

For more information, please visit www.acciumbio.com, or call Ali Arjomand (206) 281-3915, e-mail arjomand@acciumbio.com.