Associate Director, Pharmacokinetics position at Synteract

Dear Colleagues, An "Associate Director, Pharmacokinetics" position is open at Synteract. The position can be office-based or remote-based in the US. *Who We Are*Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. *Position Overview* The Associate Director, Pharmacokinetics will be responsible for conducting PK/PD modeling and population PK analyses using WinNonlin, NONMEM and/or PKSim with a focus on designing optimal dosing regimens for adult, pediatric and other special patient populations. Provide pharmacology, pharmacokinetic consulting to clients with a specialization on pediatric patient populations. Design, analyze and report pre-clinical and clinical pharmacokinetic, PK/PD modeling and trial simulation studies. *Specific tasks would include:* - Conduct PK/PD analyses, modeling and simulation in WinNonlin, NONMEM and/or PK-Sim for adult, pediatric and other special patient populations requiring dose regimen modification. - Assist clients in the design and development of pre-clinical and clinical protocols with respect to toxicokinetic and pharmacokinetic analyses - When the lead PK Scientist on assigned projects, act as the project manager to include functioning as the principal liaison with key clients, vendors, and internal team members. - When the lead PK Scientist, will create trust and confidence amongst clients, vendors and team members while delivering on-time, and on-budget programs that leverage the various resources, expertise and cross function knowledge available within Synteract. - Work with client’s data management group to prepare data sets for import and analysis in WinNonlin and/or NONMEM. - Conduct non-compartmental (NCA) and compartmental PK analysis is Phoenix WinNonlin -PKSo. - Responsible for locking and unlocking studies/scenarios in the PKSo database following management authorization. - Writing stand-alone PK reports and PK study report sections for CSR’s - Responsible for ensuring study data and study reports are retained according to the corporate records retention policy. - Ensuring corporate quality policies and SOPs are followed during the analysis and reporting of PK studies - Provide pharmacology, pharmacokinetic and drug development consulting services to clients with a specialization in pediatric drug development. *Qualifications*: - Ph.D./ Master's Degree in Pharmacokinetics or Pharmaceutical Sciences, plus knowledge of how to support pediatric Pharmacokinetic/Pharmacodynamic modeling and simulations, specifically population PK and/or PBPK with 2-5 years of experience (including Industrial or academic post-doctoral training). - Candidate must have knowledge of nonlinear mixed effect modeling and hands-on modeling experience using NONMEM - Intermediate knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations. - Intermediate proficiency in Microsoft Word, MS Project, Excel, and PowerPoint, Outlook. - Effective verbal and writing skills, English + local language, if relevant. If you’re passionate about bringing clinical trials to life, we encourage you to apply today! Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying, and verification of employment eligibility will be required as a condition of hire. Please apply at https://www.synteract.com/Careers/Career-Opportunities Best regards, *Amir Youssef, MS, PhD* Senior Director, Pharmacokinetics |*Synteract*® 430 Davis Drive, Suite 500 Morrisville, NC 27560 T: +1 919 674 8080 [email protected] *BRINGING CLINICAL TRIALS TO LIFE*™