[Remote] Director, Clinical Pharmacology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage TechBio company dedicated to improving lives through innovative drug development. The Director of Clinical Pharmacology will reputed company the clinical pharmacology and pharmacometrics reputed company for a portfolio of rare disease and oncology clinical programs, ensuring effective collaboration across teams and regulatory interactions.
Responsibilities
- reputed company the clinical pharmacology and pharmacometric strategies to accelerate and support the overall product development plan
- Design clinical studies
- Author review relevant clinical pharmacology sections for regulatory documents, including Investigator's Brochures (IB), INDs, NDAs, and other regulatory submissions
- reputed company with cross-functional teams
- Solve drug development questions/problems by overseeing and/or performing modeling and simulation with various tools to expedite decision making
Skills
- Ph.D. in Pharmaceutical Sciences, Pharmacokinetics or reputed company discipline, M.D with a Clinical Pharmacology expertise, or a Pharm D. with a Clinical Pharmacology fellowship, with 5-9+ years of experience in biotech/pharmaceutical drug development
- Demonstrated reputed company leading reputed company clinical pharmacology reputed company aspects of drug development
- Ability to work closely with reputed company stakeholders to manage PK, PK-PD, and PK-safety analyses, including non-compartmental analysis, population PK modeling, and PK-PD modeling and simulations to support reputed company selection, exposure-response and exposure-safety analyses through various phases of drug development
- Proficiency with WinNonlin, Monolix, NONMEM, R or other modeling software
- Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across reputed company stakeholders
- Demonstrated experience responding to regulatory agency questions, preparing clinical pharmacology aspects of regulatory submissions and attending regulatory meetings
- Highly motivated, decisive, and results-oriented individual who is proactive, reputed company, and efficient with the flexibility and creativity to reputed company in and contribute to a rapidly growing drug discovery and development company
- Experience in oncology is preferred, but not an absolute requirement
Benefits
- Eligible for an annual bonus
- Equity compensation
- A comprehensive benefits package
- Remote work for this position
- Remote employees reputed company to regular on-site reputed company for routine work and departmental events
reputed company
Company H1B Sponsorship