Director, Clinical Pharmacology (Oncology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Hybrid/remote within the United States, with Salt Lake City or New York City as preferred home bases. Remote employees must commit to regular on-site visits for routine work and departmental events.
Annual base salary: $212,900–$297,000, depending on location, skills, experience, and qualifications. The role is also eligible for an annual bonus and equity compensation.
Company
is a clinical-stage TechBio company developing medicines through an AI-native platform that integrates biology, chemistry, and clinical development.
What you will do
- Lead clinical pharmacology and pharmacometric strategy and execution across rare disease and oncology clinical programs.
- Develop clinical pharmacology strategies that support product development plans and regulatory interactions.
- Provide pharmacology input into Phase 1–3 clinical 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, and due diligence teams.
- Oversee or perform modeling and simulation to support dose selection, exposure-response, and exposure-safety decisions.
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.
- 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 preparing regulatory submissions, responding to health authority questions, and participating in regulatory meetings.
Nice to have
- Experience in oncology drug development.
Culture & Benefits
- Work in a cross-functional Development Sciences organization spanning discovery and development projects.
- Collaborate with clinical science, clinical operations, regulatory affairs, biostatistics, DMPK, biology, chemistry, and translational biomarker functions.
- Annual bonus and equity compensation.
- Comprehensive employee benefits package.
- Company values emphasize scientific integrity, ownership, active learning, urgency, and direct collaboration.
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