5 дней назад
Executive Director, Clinical Pharmacology/Pharmacometrics (Biotech)
136 500 - 167 200GBP
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Executive Director, Clinical Pharmacology/Pharmacometrics (Biotech): Leading clinical pharmacology and pharmacometrics strategy across rare disease and oncology programs with an accent on clinical study design, modeling and simulation, regulatory submissions, and dose selection. Focus on solving drug development questions, directing PK, PK-PD, and exposure-response analyses, and coordinating cross-functional clinical and translational teams.
Location: Remote, based in the United Kingdom, with required periodic travel
Annual base salary: £136,500–£167,200, plus annual bonus, equity compensation, and benefits.
Company
is a clinical-stage TechBio company using an AI-native drug discovery and development platform to advance medicines across oncology, rare disease, neuroscience, immunology, and other therapeutic areas.
What you will do
- Lead clinical pharmacology and pharmacometrics strategy and execution for rare disease and oncology clinical programs.
- Develop clinical pharmacology strategies and serve as the clinical pharmacology lead across programs in clinical development.
- Perform or oversee modeling and simulation to support dose selection, exposure-response analyses, and development decisions.
- Provide clinical pharmacology input into Phase 1–3 studies and dedicated clinical pharmacology studies.
- Author clinical pharmacology sections of Investigator’s Brochures, INDs, NDAs, and other regulatory submissions.
- Collaborate with clinical development, translational, preclinical, DMPK, toxicology, regulatory, biostatistics, and due diligence teams.
Requirements
- Ph.D. in Pharmaceutical Sciences, Pharmacokinetics, or a related discipline; M.D. with clinical pharmacology expertise; or Pharm.D. with a clinical pharmacology fellowship.
- 10+ years of experience in biotech or pharmaceutical drug development.
- Experience leading clinical pharmacology aspects of drug development and managing PK, PK-PD, and PK-safety analyses.
- Proficiency with WinNonlin, Monolix, NONMEM, R, or other modeling software.
- Experience responding to regulatory agency questions, preparing clinical pharmacology regulatory submissions, and attending regulatory meetings.
- Strong collaboration, influencing, conflict-resolution, decision-making, and results-oriented skills.
Nice to have
- Experience in oncology.
Culture & Benefits
- Remote work from the United Kingdom with periodic travel.
- Annual bonus eligibility and equity compensation.
- Comprehensive benefits package.
- Cross-functional collaboration across discovery and clinical development.
- Values centered on integrity, accountability, active learning, urgency, and patient impact.
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