2 дня назад
Senior Director, Quantitative Pharmacology
230 720 - 345 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Director, Quantitative Pharmacology (Clinical Pharmacology/PK-PD): Leading clinical pharmacology strategy and deliverables across early- through late-stage drug development with an accent on pharmacokinetics, pharmacodynamics, regulatory submissions, and dose optimization. Focus on integrating PK, PD, patient, and disease data, supporting model-based drug development, designing clinical pharmacology studies, and mentoring quantitative pharmacology teams.
Location: Remote; compensation information applies to individuals hired to perform the role in the United States.
Salary: $230,720–$345,000 annually, plus incentive opportunity.
Company
Pharmaceutical Companies develops pharmaceutical products and conducts drug development across clinical and translational research programs.
What you will do
- Lead clinical pharmacology activities across pre-IND, IND, Phase 1–3, and registrational development programs for small- and large-molecule drugs.
- Develop and optimize clinical pharmacology strategies, including dose finding, dose optimization, exposure-response analyses, pediatric development, and study design.
- Review, approve, and lead clinical pharmacology reports, PK/PD analyses, regulatory filing sections, and related development documentation.
- Serve as the clinical pharmacology lead on cross-functional teams and communicate data-driven strategies and recommendations to development teams.
- Coordinate with pharmacometrics, biomarker, bioanalytical, toxicology, ADME, clinical, regulatory, statistics, formulation, and CMC functions.
- Review business development opportunities, contribute to QTR strategy, and train and mentor junior quantitative pharmacology team members.
Requirements
- PhD in clinical pharmacology or a related field such as pharmacokinetics, pharmacology, or pharmaceutics.
- At least 12 years of experience in clinical pharmacology or related areas.
- Extensive experience developing and executing clinical pharmacology strategies from early-stage through late-stage and registrational programs.
- In-depth knowledge of early-phase study design, PK, PD, drug metabolism, biopharmaceutics, biomarkers, and bioanalytical assays for small molecules and monoclonal antibodies.
- Hands-on experience with PK and PK/PD data analysis, including Phoenix NLME, and strong knowledge of Phase I clinical operations and multi-region regulatory requirements.
- Strong leadership, communication, organization, scientific problem-solving, and cross-functional collaboration skills.
Nice to have
- Experience developing early-phase clinical protocols.
Culture & Benefits
- Remote work arrangement with approximately 20% travel.
- Medical, dental, vision, and prescription drug coverage.
- Basic life, accidental death and dismemberment, and short- and long-term disability insurance.
- Tuition reimbursement, student loan assistance, and a generous 401(k) match.
- Flexible time off, paid holidays, and paid leave programs.
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