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*™