1 день назад
Associate Director, Quantitative Pharmacology, Clinical Pharmacology
169 222 - 253 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Quantitative Pharmacology, Clinical Pharmacology (PK/PD and Drug Development): Providing clinical pharmacology input across small- and large-molecule development from pre-IND through regulatory submissions with an accent on clinical study design, PK/PD analysis, and cross-functional drug development. Focus on developing model-based drug development strategies, interpreting exposure-response data, authoring regulatory documents, and coordinating pharmacology activities across bioanalytical, formulation, and pharmacometrics teams.
Location: Remote within the United States; travel up to 15%
Salary: $169,222–$253,000 annually, plus incentive opportunity
Company
is a pharmaceutical company developing small- and large-molecule medicines across multiple therapeutic areas.
What you will do
- Provide clinical pharmacology input across pre-IND, IND, Phase 1–3, PK, PK/PD, and regulatory activities.
- Lead clinical pharmacology work on cross-functional project teams, including study design, protocol development, execution, reporting, and data interpretation.
- Conduct translational and clinical PK and PK/PD analyses, including noncompartmental, correlation, exposure-response, and meta-analysis work.
- Support pharmacometrics, modeling and simulation, and model-based drug development strategies.
- Author clinical pharmacology sections for IND/NDA applications, investigator brochures, annual reports, pediatric development plans, and scientific publications.
- Coordinate bioanalytical, formulation, outsourcing, budget, statement-of-work, and invoice approval activities.
Requirements
- PhD, PharmD, or MS in Clinical Pharmacology or a related field, with at least 4 years of industry experience.
- In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
- Hands-on PK and PK/PD analysis experience using software such as Phoenix NLME and R.
- Working knowledge of Phase I clinical operations, drug development, multi-region regulatory requirements, and PK/PD analysis.
- Strong scientific problem-solving, organization, communication, and collaboration skills.
- Must be eligible to perform the role in the United States.
Nice to have
- Experience in population PK and PK/PD modeling.
- Experience with statistical models.
Culture & Benefits
- Cross-functional collaboration with clinical, non-clinical, bioanalytical, formulation, pharmacometrics, and business development groups.
- Comprehensive medical, dental, vision, and prescription drug coverage.
- Company-provided life and disability insurance.
- Tuition reimbursement and student loan assistance.
- 401(k) match, flexible time off, paid holidays, and paid leave programs.
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