2 часа назад
Associate Director/Director (Clinical Pharmacology)
164 000 - 205 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director/Director (Clinical Pharmacology): Designing and executing clinical pharmacology strategies for oncology small-molecule programs with an accent on PK/PD study design, dose selection, and regulatory documentation. Focus on applying PBPK, population PK, exposure-response modeling, and DDI assessment to support clinical development and health authority interactions.
Location: Remote - US; San Diego headquarters
Salary: Associate Director $164K–$205K; Director $196K–$245K per year
Company
is a clinical-stage life-science and technology company developing medicines through an AI-driven discovery and development platform.
What you will do
- Design and execute clinical pharmacology strategies for oncology small-molecule programs from IND-enabling activities through Phase 1 and later development.
- Analyze and interpret clinical PK, PK/PD, and exposure-response data across multidisciplinary development teams.
- Design first-in-human, drug-drug interaction, hepatic and renal impairment, food-effect, cardiac safety, and combination-therapy studies.
- Apply PBPK, population PK, and exposure-response modeling to support dose selection and DDI risk assessment.
- Author and review protocols, investigator brochures, SOPs, statistical analysis plans, clinical study reports, regulatory submissions, and responses to health authority queries.
- Contribute to scientific publications and mentor junior scientists within the clinical pharmacology function.
Requirements
- PhD or equivalent in pharmacology, biomedicine, biochemistry, or a related scientific discipline, with at least 5 years of relevant pharmaceutical, contract research, or clinical research experience.
- Experience with clinical development of oncology small-molecule therapeutics, including dose-escalation, dose-expansion, and combination-therapy trials.
- Proficiency with Phoenix WinNonlin for non-compartmental analysis.
- Working knowledge of PBPK modeling, ICH M12, FDA DDI guidance, and related regulatory frameworks.
- Hands-on experience writing clinical and regulatory documentation, plus strong project management and cross-functional communication skills.
Nice to have
- Familiarity with PK bioanalytical method development and validation.
Culture & Benefits
- Inclusive environment focused on collaboration, diversity, and teamwork.
- Company-paid healthcare, flexible spending accounts, voluntary life insurance, and 401(k) matching.
- Uncapped vacation.
- San Diego facility with an onsite gym and dining.
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 →
Похожие вакансии
3 дня назад
Director of Clinical Pharmacology (AI)
1 день назад
Associate Director, Pharmacology (AI Pharma)
177 500 - 232 000$
1 день назад
Associate Director, Analytical Development & QC (Pharma)
177 500 - 232 000$
24 часа назад
Associate Director, Bioanalytical Development (Pharma)
177 500 - 232 000$
3 дня назад
Associate Director, Scientific Communications (Biotech)
210 000 - 255 000$
1 день назад
Associate Director, Regulatory Affairs CMC (Biopharmaceuticals)
164 000 - 213 000$