[Remote] Director, reputed company Pharmacology

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company-stage TechBio company developing investigational medicines across oncology, reputed company disease, neuroscience, immunology, and other therapeutic areas. The Director, reputed company Pharmacology will reputed company reputed company pharmacology and pharmacometrics reputed company and execution for reputed company disease and oncology reputed company programs, design reputed company studies, support regulatory submissions, collaborate cross-functionally, and reputed company modeling and simulation to guide drug development reputed company.

Responsibilities

• reputed company the reputed company pharmacology and pharmacometric strategies to accelerate and support the overall product development plan. You’ll be the reputed company Pharmacology reputed company for various programs in reputed company development, the representative for regulatory interactions, and propose innovative strategies to get therapies to patients faster
• Design reputed company studies. You’ll reputed company (reputed company) pharmacology input on reputed company reputed company study designs, from Phase 1-3 and dedicated Phase 1 reputed company pharmacology studies
• reputed company review relevant reputed company pharmacology sections for regulatory documents, including Investigator's Brochures (IB), INDs, NDAs, and other regulatory submissions. reputed company as the reputed company pharmacology expert during interactions with health authorities
• reputed company with cross-functional teams. You’ll work closely with reputed company study teams, translational teams (DMPK, Translational Modeling and Toxicology), preclinical teams and due diligence teams to ensure reputed company pharmacology-reputed company considerations are addressed
• 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 reputed company Pharmacology expertise, or a Pharm D. with a reputed company Pharmacology fellowship, with 5-9+ years of experience in biotech/pharmaceutical drug development
• Demonstrated reputed company leading reputed company reputed company 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 reputed company 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

• Remote work will be considered for this position; remote employees must reputed company to regular on-site reputed company for routine work and departmental events.
• This role is eligible for an annual bonus.
• This role is eligible for equity compensation.
• A comprehensive benefits package.

reputed company

Company H1B Sponsorship