Senior Simulation Scientist building Workbench’s warehouse simulation engine for Fulfillment IQ, a supply chain engineering company. Leading zero - to - one modeling, product integration, and simulation team growth.
About the role
- PK Scientist II conducting PK/PD analyses and modeling for Everest, a global clinical research CRO. Supporting clinical trials, regulatory submissions, and pharmacology documentation.
Responsibilities
- Conduct PK/PD data analysis using non-compartmental analysis
- Support PK/PD modeling and simulations using Phoenix WinNonlin, NLME, Monolix, R, and related software
- Apply strategic direction and vision on PK/PD data analysis to support clinical trial designs, compound development plans, and regulatory submissions
- Generate predictive simulations and provide input into trial protocol development
- Provide input into clinical trial Statistical Analysis Plans and mock tables, listings, and graphs shells, including PK/PD analysis components
- Author standalone PK/PD Analysis Plans, including PK/PD mock shells
- Author and/or review PK/PD-related documents and reports, including protocols and PK Study Reports
- Contribute to clinical pharmacology sections of protocols, clinical study reports, Investigator's Brochures, briefing documents, and IND/NDA/ANDA submissions
- Work with regulatory affairs personnel to provide PK/PD data for regulatory communications and presentations as needed
- Maintain and adhere to divisional SOPs, guidelines, therapeutic-area standards, and conventions
- Keep current with pharmaceutical drug trial regulator and ICH requirements or guidelines
- Plan and carry out professional development
Requirements
- Advanced degree, Ph.D., or M.Sc. in Clinical Pharmacology (including Pharmacokinetics, Pharmacodynamics), Pharmacy, Biopharmaceutics, or related field
- At least 2 to 4 years’ experience as a PK Scientist or related role in the pharmaceutical clinical trial environment
- Experience in multiple therapeutic areas and Phase I through IV clinical trials is preferred
- Proficient in using WinNonlin, or equivalent
- Other relevant pharmacometric software for non-compartmental analysis, PK/PD analysis, and modeling is preferred
- Familiarity with SAS and/or R is preferred (or willingness to learn and master SAS skills)
- Excellent understanding of clinical trials and common clinical trial statistical analysis methods is preferred
- Skilled in scientific writing and data interpretation is preferred
- Demonstrated ability to understand PK results
- Able to communicate effectively, orally and in writing
- Demonstrated ability for logical thinking, vision, and creativity necessary to function effectively with a large degree of independence and little supervision
- Experience with client relationship management is preferred
- Ability to multi-task and manage multiple projects with competing and aggressive timelines
- Excellent interpersonal and teamwork skills; detail-oriented, customer-, and quality-focused
- Well organized and able to work independently
- Strong understanding of fundamental PK/PD and statistical principles
Benefits
- Medical, dental, and vision coverage
- Life and AD&D insurance
- Short- and long-term disability
- Tuition reimbursement
- Fitness reimbursement
- Employee assistance program (EAP)
- Pension plan
- Generous paid time off and sick leave
- Opportunity to earn a performance based bonus
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