Pharmacokinetics Laboratory Associate Director

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

• With the Laboratory Director, is responsible for the scientific and technical oversight of a clinical/bioanalytical laboratory, which is specialized in Therapeutic Drug Monitoring (TDM). Must ensure compliance with all applicable regulations to ensure high quality testing and patient safety.
• Must be able to work independently and collaboratively with the Pharmacokinetics (PK) Laboratory team and upper administration.
• Must be accessible to provide oversight of pharmacokinetic modeling of busulfan and subsequent dose recommendations, pharmacogenetics test results, and any other active assays.

Responsibilities

• Ensure that testing systems and methodologies developed and performed for drug concentration analyses meet all quality requirements under CLIA/CAP guidelines.
• Ensure that testing reports include necessary information required for attending physicians to choose the optimal dose to attain the desired target exposure as determined by the physician.
• Be accessible to the laboratory to provide onsite, telephone, or electronic consultation to laboratory staff and clients during laboratory operating hours.
• Evaluate opportunities and lead expansion of billable tests for the Laboratory.
• Work with PK Laboratory Director, Manager, and team to optimize existing and new assay methods. Ensure standard operating procedures (SOPs) are written and consistent with the methods performed in the laboratory and are adequate to determine the reliability, accuracy, precision, and other relevant characteristics of test methods. Ensure the establishment and maintenance of acceptable levels of analytical performance per SOP for each testing system and method. Ensure all necessary remedial actions taken are documented whenever significant deviations occur from the laboratory's established performance standards.
• Provide consultation to physicians and investigators in developing new treatment plans and clinical research protocols relating to personalized drug dosing and clinical pharmacology. Participate in preparing related publications as primary or contributing author.
• Provide opportunities for ongoing education and training for laboratory staff to maintain and enhance expertise in pharmacokinetics and pharmacogenomics testing. Provide education to clinicians and other groups, as appropriate.
• Stay up to date with the research and technology and continue to push scientific boundaries in the field of precision medicine.

Qualifications

Required:

• Earned doctoral degree (PhD) in a chemical, physical, biological or clinical laboratory science or an MD, DO, DPM, DMD, or DCLS degree, at least one year of clinical laboratory experience.
• At least 2 years of working experience after terminal degree
• Must be eligible for licensure in the State of Washington.
• Must have or be eligible for HHS-approved board certification. Must meet the qualifications as a laboratory director of a laboratory performing high complexity testing under the CLIA '88 regulations, Subpart M, Section 493.1443.
• Experience/knowledge in/of pharmacokinetics, pharmacodynamics, pharmacogenomics, and/or pharmacometrics.
• Stro