4 дня назад
Director, Clinical Pharmacology (Oncology)
118 300 - 136 500GBP
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Clinical Pharmacology (Oncology) (Clinical Pharmacology/Pharmacometrics): Leading clinical pharmacology and pharmacometric strategy for rare disease and oncology clinical programs with an accent on study design, regulatory submissions, and dose-selection analyses. Focus on designing Phase 1–3 studies, overseeing PK/PK-PD modeling and simulations, and resolving complex drug development questions across cross-functional teams.
Location: London or Oxford (Milton Park), United Kingdom; remote work is considered, with regular on-site visits required for routine work and departmental events.
Annual base salary: £118,300–£136,500, plus annual bonus, equity compensation, and benefits.
Company
is a clinical-stage TechBio company using an AI-native platform to develop investigational medicines for oncology, rare disease, neuroscience, immunology, and other areas of unmet need.
What you will do
- Lead clinical pharmacology and pharmacometric strategies for a portfolio of rare disease and oncology clinical programs.
- Serve as the clinical pharmacology lead for development programs and represent the function in regulatory interactions.
- Provide pharmacology input into Phase 1–3 clinical study designs and dedicated clinical pharmacology studies.
- Author clinical pharmacology sections of Investigator’s Brochures, INDs, NDAs, and other regulatory submissions.
- Oversee or perform modeling and simulation to support dose selection, exposure-response, and exposure-safety decisions.
- Collaborate with clinical development, translational, preclinical, DMPK, biomarker, regulatory, biostatistics, and due diligence teams.
Requirements
- Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or a related discipline; or an M.D. with clinical pharmacology expertise; or a Pharm.D. with a clinical pharmacology fellowship.
- 5–9+ years of experience in biotech or pharmaceutical drug development.
- Demonstrated success leading clinical pharmacology aspects of drug development.
- Experience with PK, PK-PD, and PK-safety analyses, including non-compartmental analysis, population PK modeling, and PK-PD modeling and simulations.
- Proficiency with WinNonlin, Monolix, NONMEM, R, or other modeling software.
- Experience responding to regulatory agency questions, preparing regulatory submissions, and attending regulatory meetings.
Nice to have
- Experience in oncology.
Culture & Benefits
- End-to-end collaboration across discovery and clinical development.
- Work with clinical pharmacology, pharmacometrics, translational modeling, and clinical biomarker functions.
- Annual bonus and equity compensation.
- Comprehensive benefits package.
- Values emphasize scientific integrity, active learning, urgency, accountability, and cross-functional collaboration.
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