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2 дня назад

Senior Director, Quantitative Pharmacology

230 720 - 345 000$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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