Director of Pharmacokinetics
Director of Pharmacokinetics
Office-based or Remote-based
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.
The 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. This role could be an Executive Director depending on the experience of the candidate.
Specific tasks would include:
- Assist pharmaceutical clients in the design and development of pre-clinical and clinical study 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 functional knowledge available within the Company.
- Work with client’s data management group to prepare datasets for import and analysis in WinNonLin, NonMem and PK-Sim
- Conduct non-compartmental (NCA) and compartmental PK analysis in Phoenix WinNonLin-PKSo and interpret the results.
- Responsible for locking and unlocking studies/scenarios in the PKSo database following data management authorization.
- Writing stand-alone PK reports and PK study report sections for Clinical Study Report’s (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.
- Conduct PK/PD analyses, modeling and simulation in WinNonLin, NonMem and PK-Sim for pediatric patients’ and other special patient populations requiring dose regimen modification.
- Perform gap analysis in pre-clinical metabolism and pharmacokinetic studies.
- Dose estimation or dose predictions in pediatric and healthy subjects and serve as subject matter expert on pediatric dosing methodologies including PBPK and allometric scaling approaches.
- Supervisory responsibilities include but are not limited to providing technical and operational guidance and direction, training, mentoring, and development of staff, ensuring quality and accuracy of work, ensuring deliverables timelines are met, and administering company policies including performance management.
- Manages and supports the coordination of department operations and project deliverables; continued growth through the development and management of the department ensuring optimal performance; continued improvement through implementation of processes and technologies.
- Anticipates problems and identifies solutions. Reports regularly to senior leadership as appropriate.
- Subject matter expert on pediatric dosing metholodies including allometric scaling approaches.
- Ph.D. / Master’s Degree in Pharmacokinetics or Pharmaceutical Sciences, plus knowledge of how to support pediatric Pharmacokinetic/Pharmacodynamics modeling and simulations, specifically population PK. 7+ years of experience effectively managing results in terms of costs and/or methods and employees with a minimum of 1-2 years effectively contributing to the business plan at both the tactical and strategic level.
- Intermediate knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Intermediate proficiency in Microsoft Word, MS Project, Excel, and PowerPoint, Outlook. Hands on training on WinNonLin, NonMem and/or PK-Sim
- Effective verbal and writing skills; English + local language, if relevant.
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