Research Director Pharmacokinetics

Nanosep AB; Reading; On-site; GBP 60,000 - 100,000; Full time

Job summary

A leading clinical research organization is seeking a Research Director Pharmacokinetics to oversee Phase I-IV studies and drive innovative drug development strategies. The ideal candidate will hold a Ph.D. in Pharmacokinetics or related fields, possess extensive experience in clinical pharmacology, and demonstrate strong analytical and leadership skills. Join us at Nanosep AB to influence the future of drug development and improve patient outcomes globally.

Qualifications

• 5 years experience or 7 years experience in a related field.
• Knowledge of Pharmacokinetic concepts and PK modeling.
• Ability to prioritize and manage multiple projects.

Responsibilities

• Perform analysis and reporting of clinical pharmacology studies.
• Develop protocols and statistical analysis plans.
• Consult with clients on study designs.

Skills

Problem solving

Analytical skills

Coaching

Communication

Education

Ph.D. or educational equivalent in Pharmacokinetics, Pharmaceutics, or related field

Master's Degree or PharmD in Pharmacy or related field

Tools

Microsoft Office

WinNonlin

SigmaPlot

NONMEM

SAS programming

Job description

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Job Overview

Perform analysis and reporting of 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. Provide consulting on study design, or other aspects of Clinical Pharmacology projects, clinical development plans, and dossiers for product registration. Assist Clinical Pharmacology management in implementing strategic initiatives.

Job Overview

Perform analysis and reporting of 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. Provide consulting on study design, or other aspects of Clinical Pharmacology projects, clinical development plans, and dossiers for product registration. Assist Clinical Pharmacology management in implementing strategic initiatives.

Essential Functions

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

Master's 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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Medical and Diagnostic Laboratories

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