Principal Pharmacometrician, FSP

Why DSSS?

Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This affords all the benefits of working for an industry leading global CRO while operating within a sponsor team and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech companies offering you a unique opportunity to work on a team where your role is both challenging and rewarding, alongside colleagues who are passionate about influencing the future of medicine and advancing therapies. With IQVIA's DSSS, you become a core part of a dynamic team dedicated to reshaping the future of healthcare.

Additional Benefits:

• Home-based, remote work opportunities.
• Work/life balance.
• Collaborate on projects and innovations with industry leaders in the Pharma and CRO sectors.
• Cohesive team environment fostering a collaborative approach to study work.
• Variety of therapeutic areas, indications, and study phases.
• Job stability; long-term engagements and development opportunities.
• Career advancement opportunities.

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.

Qualifications:

• 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.

#LI-Remote

#LI-NITINMAHAJAN

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe