Principal Pharmacometrician, FSP

Location: Permanent Home-based - Europe

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, analysis plans, PK/PD analysis, and pharmacometric reports for pre-clinical or Phase I-IV clinical studies.
• Consult with Clinical Pharmacology staff on study design, analyses, clinical development plans.
• Plan and execute a wide range of pharmacometric analyses to inform clinical pharmacology and drug development decisions
• Prepare or review PK/PD sections of dossiers for product registration and communicate with regulatory agencies.
• Assess pharmacometric requirements for and ensure integration of pharmacometric information into drug development milestones and development decisions.
• 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 pharmacometrics and clinical pharmacology, based on current literature, application of new technology, attendance at professional meetings, etc.

Qualifications:

• PharmD, Ph.D. (or equivalent) in pharmacology, pharmacy, pharmacometrics, pharmaceutics, biology, mathematics, statistics, engineering, or a field with significant modeling-related content/training required
• Minimum of 3 years’ experience in Pharmacokinetics or Pharmacology for Clinical Research Organization or pharmaceutical environment
• Minimum of 2 years in applying model-based methods in pre-clinical and clinical drug development
• Expert knowledge of pharmacometric concepts, including compartmental and noncompartmental analysis, population PK modeling, current therapeutic environment, and drug development trends.
• Scientific skills demonstrated in facilitating the (early/full) clinical development strategy
• 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