rpdpkregulatory submissionsmodeling and simulationpharmacokineticsnonmemclinical pharmacologypopulation pkpharmacometricsexposure response analysis
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
Пожаловаться
Зарплата и рынок
$164к-246к/год
$200к$240кмедиана$270к
По похожим ролям (34) ~ $240к/год
88
Хорошая вакансия
развернуть
Чётко очерченная руководящая роль в известной биофармацевтической компании даёт широкое влияние на разработку препаратов, хотя динамичная матричная среда может быть требовательной.
Кликните для подробной информации
Высокий темпАктуальные методыВлияние на разработкуРазработка лекарств
Оценка от Hirify AI
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Подключить Plus
Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Associate Director, Pharmacometrics (Pharmacometrics/PK-PD): Leading population PK, PK/PD, exposure-response analysis, and pharmacometrics strategy for international drug development programs with an accent on modeling, simulation, clinical study design, and regulatory submissions. Focus on developing dose-selection and optimization models, integrating Model Informed Drug Development principles, and supporting programs from research through registration and commercialization.
Location: Remote/Home-Based in the United States; listed locations are Palo Alto, CA and Philadelphia, PA
Base pay for US-based candidates: $164,000–$246,000 annually, plus potential bonus, equity, and benefits.
Company
hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, oncology, and neuroscience.
What you will do
Develop pharmacometrics strategies for multiple portfolio programs from research through registration and beyond.
Design, perform, interpret, and report population PK, PK/PD, and exposure-response analyses.
Provide hands-on modeling and simulation support for dose selection, optimization, and clinical development.
Support clinical study protocol design, data analysis, reporting, CSRs, and regulatory documents for Phase 1–4 studies.
Prepare development plans and regulatory submissions, respond to agency queries, and support inspections.
Manage pharmacometrics consultants and vendors and contribute to cross-functional Model Informed Drug Development activities.
Requirements
PhD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences, with 5+ years of experience analyzing clinical pharmacokinetic and pharmacokinetic-pharmacodynamic data.
Strong understanding of clinical pharmacology, pharmacometrics principles, and the drug development process.
Experience performing PK/PD modeling and simulation using software such as NONMEM, Monolix, Phoenix WinNonlin, R, GastroPlus, SimCYP, ADAPT, or PK-Sim.
Ability to work independently and collaboratively in a multidisciplinary team environment.
Ability to succeed in a fast-paced, highly matrixed work environment.
Excellent written and oral communication, including presentation skills.
Ability to embody and model Jazz core values.
Nice to have
Experience interacting with regulatory agencies.
Culture & Benefits
Remote/home-based role supporting international drug development programs.
Cross-functional collaboration in a multidisciplinary and highly matrixed environment.
US-based employees may receive medical, dental, and vision insurance, a 401(k) retirement savings plan, and flexible paid vacation.
Potential eligibility for discretionary annual cash bonus or incentive compensation and equity grants.
Equal opportunity employer.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →