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Research Director Pharmacokinetics

5 - 10 years

5 - 10 Lacs

Bengaluru Karnataka India

Posted:1 month ago| Platform: Foundit logo

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Skills Required

PK/PD analysis population modeling WinNonlin/NONMEM clinical pharmacology strategy Regulatory Submissions

Work Mode

On-site

Job Type

Full Time

Job Description

  • As a project PK Scientist develop or oversee the development of protocols, statistical analysis plans, PK/PD analysis, PK/PD tables, listings and figures, and clinical study reports for Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies.
  • Consult with clients, external IQVIA divisions, and Clinical Pharmacology staff on study design, or other aspects of Clinical Pharmacology projects, and clinical development plans.
  • Prepare PK/PD sections of global dossiers for product registration and communicate with local regulatory agencies.
  • Ensure quality and timely delivery of the project PK/PD deliverables to IQVIA clients.
  • Provide update to the IQVIA Project Manager on status of project PK/PD deliverables.
  • Participate on project-related cross functional teams that include Project Manager, CRA, Data Manager, Biostatistician, Programmer, and/or Medical Writer.
  • Consult and interact with clients, other IQVIA divisions, and third-party vendors.
  • Provide technical training, guidance, and mentorship to lower level and new staff.
  • Participate in proposal and budget development for Clinical Pharmacology PK/PD components of business proposals.
  • Recommend and assist in implementation of quality control (QC) assessment and procedures and scientific review.
  • Assist management in implementing strategic initiatives.
  • Maintain awareness of overall developments in the field of Clinical Pharmacology and PK/PD based on current literature, application of new technology, attendance at professional meetings, etc.
  • Perform other duties as assigned by Clinical Pharmacology Management.

  • Qualifications

  • Ph.D. or educational equivalent in Pharmacokinetics, Pharmaceutics, or related field Req Or
  • Masters Degree or PharmD in Pharmacy or related field Req
  • 5 years experience Req Or
  • 7 years experience Req Or
  • Equivalent combination of education, training and experience Req
  • Sound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling as required, current therapeutic environment and drug development trends
  • Sound knowledge of appropriate PK/PD standards and processes
  • Strong understanding of the principles of the drug development process, ICH GCP, and applicable International and national regulatory requirements
  • Good coaching and mentoring skills
  • Good problem solving and analytical skills
  • Excellent computer skills, including proficiency with Microsoft Office, WinNonlin, and SigmaPlot graphics, as well as NONMEM, SPlus and basic SAS programming, as required
  • Excellent verbal and written communication skills and highly effective interpersonal, and organizational skills
  • Ability to work within a matrix team environment
  • Ability to prioritize, and independently coordinate and manage PK/PD component of complex projects
  • Ability to interact in a cross-functional and multi-cultural team environment
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

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Iqvia Biotech logo
Iqvia Biotech

Pharmaceuticals / Biotechnology

Nashville

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