Principal Pharmacometrician, FSP at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, CROIndustries

Requirements

PharmD, Ph.D. in Pharmacology, Pharmacy, Pharmacokinetics, Pharmaceutics, Biology, or similar required
Minimum of 3 years’ experience in Pharmacokinetics or Pharmacology for Clinical Research Organization or pharmaceutical environment
Expert knowledge of pharmacometric concepts, including noncompartmental analysis and population PK modeling, current therapeutic environment, and drug development trends
Strong understanding of the principles of the drug development process, ICH GCP, and applicable international and national regulatory requirements
Good problem solving and analytical skills
Excellent computer skills, including proficiency with Microsoft Office, WinNonlin, and graphing, as well as NONMEM, R, and basic SAS programming
Excellent verbal and written communication skills and highly effective interpersonal, and organizational skills
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

Responsibilities

Contribute to 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 Clinical Pharmacology staff on study design, clinical development plans
Review analyses and documents prepared by CROs to help ensure accuracy and appropriateness
Prepare or review PK/PD sections of dossiers for product registration and communicate with regulatory agencies
Ensure quality and timely delivery of project PK/PD deliverables
Collaborate in cross functional teams that include Project Manager, CRA, Data Manager, Biostatistician, Programmer, and/or Medical Writer
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

Skills

Pharmacometrics

PK/PD analysis

Population PK/PD

Statistical analysis plans

Clinical study reports

Study design

Clinical pharmacology

Regulatory dossiers

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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