Executive Director, Clinical Pharmacology/Pharmacometrics
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Remote, United States; periodic travel required.
Annual base salary: $287,980–$346,060 in New York City, Boston, and the San Francisco Bay Area; $261,800–$314,600 in Salt Lake City and other U.S. locations. Annual bonus, equity compensation, and benefits are also available.
Company
is a clinical-stage TechBio company using AI, biology, chemistry, and clinical development to advance investigational medicines for oncology, rare disease, neuroscience, immunology, and other areas of unmet need.
What you will do
- Lead clinical pharmacology and pharmacometric strategy and execution across clinical development programs.
- Develop modeling and simulation strategies to support product development and accelerate decision-making.
- Provide clinical pharmacology input into Phase 1–3 studies and dedicated clinical pharmacology studies.
- Prepare clinical pharmacology sections for Investigator’s Brochures, INDs, NDAs, and other regulatory submissions.
- Represent clinical pharmacology in regulatory interactions and meetings with health authorities.
- Collaborate with clinical development, DMPK, translational modeling, toxicology, preclinical, 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.
- Experience with non-compartmental analysis, population PK modeling, PK-PD modeling, and simulations for dose selection and exposure-response or exposure-safety analyses.
- Proficiency with WinNonlin, Monolix, NONMEM, R, or other modeling software.
- Experience preparing regulatory submissions, responding to agency questions, and attending regulatory meetings.
Nice to have
- Experience in oncology.
Culture & Benefits
- Remote work arrangement with periodic travel.
- Annual bonus and equity compensation.
- Comprehensive benefits package.
- Cross-functional collaboration across discovery and development teams.
- Values emphasize scientific integrity, ownership, adaptability, urgency, and direct collaboration.
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