Associate Director, Pharmacometrics

Job not on LinkedIn

🔥 2 minutes ago

🏄 California, Pennsylvania – Remote

🏄 California – Remote 🔔 Pennsylvania – Remote

💵 $164k - $246k / year

⏰ Full Time

🟠 Senior

👔 Director

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• Develop pharmacometrics strategies for multiple programs • Design, perform, interpret, and report population PK, PK/PD, and exposure-response analyses • Provide hands-on population PK and PK/PD modeling and simulation support for development projects, including dose selection and optimization • Design clinical study protocols and analyze and interpret study data • Prepare clinical study reports and regulatory documents, including INDs, NDAs, and IBs • Determine scope, design, planning, and analysis of Phase 1–4 pharmacokinetic and pharmacodynamic studies • Develop appropriate population PK models and PK/PD analyses to support development and regulatory objectives through commercialization • Plan, prepare, and review drug development plans and regulatory filings • Contribute relevant sections to IND and NDA/BLA regulatory submissions • Address regulatory agency queries during reviews and inspections • Identify and manage consultants and vendors supporting pharmacometrics analyses • Participate effectively on cross-functional teams to integrate Model Informed Drug Development principles

🎯 Requirements

• PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences • 5+ years of experience with clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data analysis • Strong understanding of clinical pharmacology and pharmacometrics principles and the drug development process • Experience performing modeling and simulation tasks using software for PK/PD analysis, such as NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, or PK Sim • Experience in regulatory agency interactions is a plus • Ability to work independently and collaboratively in a multidisciplinary team environment • Ability to navigate and succeed in a fast-paced, highly matrixed work environment • Excellent written and oral communication skills, including presentation skills • Embody and model Jazz core values

🏖️ Benefits

• Discretionary annual cash bonus or incentive compensation, depending on the role • Discretionary equity grants under Jazz’s Long Term Equity Incentive Plan • Medical insurance • Dental insurance • Vision insurance • 401k retirement savings plan • Flexible paid vacation

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