Careers in Quality

Description

PURPOSE OF POSITION: To learn to conduct independent research and support the independent research of others in a Medical Center dedicated to the care of infants; children; and adolescents.

There is an immediate opening for a postdoctoral Research Fellow or Research Associate position in the Division of Clinical Pharmacology at Cincinnati Children's Hospital Medical Center. The research is focused on the application of pharmacokinetic/pharmacodynamic/pharmacogenetic and disease modeling and clinical trial simulation to facilitate pediatric drug study design and improve individualized patient care. The emphasis of the position is to conduct population PK/PD modeling and clinical trial simulation analyses in close collaboration with clinical research teams and corporate sponsors for ongoing precision medicine projects across different therapeutic areas. The research fellow/associate will conduct PKPD modeling and simulation analyses in support of drug development and dose optimization using model-informed precision dosing strategies for pediatric and adult clinical studies. The ideal candidate should have a strong interest in model-informed drug development (MIDD), pharmacometrics and biostatistical approaches (such as nonlinear mixed effects modeling and Bayesian statistics) to evaluate and optimize pharmacotherapy.

REPRESENTATIVE RESPONSIBILITIES

???Perform analysis and experiments
Design, execute, and record analysis and experiments; apply standard scientific protocols to research, and improve current methods and evaluate innovative techniques. Develop and implement human subject research protocols, and design experimental procedures and documentation in accordance with the relevant laws and regulations. Prepare, clean and analyze data. Maintain optimal protocol and accuracy by conducting regular quality and reproducibility checks.

???Communicate results/findings
Draft, write, and edit scientific reports, papers, journal articles, and abstracts. Present information on research and department work to others at department meetings, journal clubs, and seminars. Present results and discuss relevant insights with Faculty and provide useful recommendations and analysis. Assist in grant applications as needed.

???Innovate and advance departmental capabilities
Independently reproduce, evaluate, research, and improve techniques currently used. Adapt new methods to existing procedures and modify current analysis/experiments through scientific knowledge and intuition. Maintain accurate and detailed records of all analysis and experiments. Develop, set-up, and verify new procedures in the department. Standardize and establish new published procedures; evaluate innovative techniques. Develop new protocols; design formats. Maintain an integral role in the department's meetings, presentations, and publications. Troubleshoot and correct erroneous results or problems with department software/equipment. Maintain and repair software/equipment; monitor proper use by personnel.

???Education and Training
May serve as course master and develop new courses at the undergraduate and graduate level, including appropriate plans for evaluating student performance; may deliver lectures as a guest lecturer in courses organized by other faculty. Assist in the training of new employees. Serve as a resource and/or mentor to coworkers. Assist in the development and presentation of department training. Identify training needs and provide necessary coaching.

Qualifications

EDUCATION/EXPERIENCE

Required:

PhD, PharmD, or MD in Pharmacokinetics, Pharmaceutical sciences, Pharmacy, Biostatistics or related discipline at the time of appointment.

Preferred:

??? PhD, PharmD, or MD in Pharmacokinetics, Pharmaceutical sciences, Pharmacy, Biostatistics or related discipline Working knowledge of PK/PD modeling and simulation, and related software packages,
??? Understanding of statistics (nonlinear mixed effects modeling, Bayesian statistics, and clinical trial simulation)
??? Strong programming skills in R language
??? Prior experience and knowledge related to PBPK software such as Simcyp and to pharmacometrics approaches in the development of biologics and therapeutic proteins would be a plus.
??? Excellent communication skills and capability of working in a multi-disciplinary team and to learn and integrate knowledge across different therapeutic areas.

Unique Skills:

???Scientific Writing
Strong scientific writing abilities

???Programming - Basic
Working knowledge of computer programming

???Organization
Strong organizational and project management skills to handle projects independently.

???Time Management
Prioritization and time-management skills sufficient to meet deadlines in a fast-paced environment

???Analysis
Strong analytical skills with the ability to make judgments and recommendations based on statistical analysis

???Statistics - Intermediate
Familiarity with statistical software, statistical techniques, statistical process control principles, and graphical data display

???Research Methods Skills
Designing and conducting effective research studies that address measurement, data collection, and validity issues; identifying or developing appropriate, accurate, relevant, and reliable measurement methods; drawing appropriate conclusions from study results

???Communication - Advanced
Excellent verbal, written and interpersonal communication skills.