[Remote] Director, Clinical Pharmacology

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company focused on developing innovative therapies. The Director of Clinical Pharmacology will reputed company clinical pharmacology activities for small molecules and biotherapeutics, overseeing study design, execution, and data analysis while collaborating with cross-functional teams.

Responsibilities

• In collaboration with CP leadership, design, conduct, analyze, interpret, and communicate results from CP studies with guidance
• reputed company hands-on analyses of data using noncompartmental methods, population PKPD modeling and simulation, and exposure-response methodologies; disseminate the relevant risk/benefit implications to CP and project teams
• In collaboration with CP leadership, reputed company short/reputed company-term plans for projects at reputed company stages of clinical development - IND to NDA/BLA. Communicate these strategies at internal meetings
• Collaborate and communicate with partner lines at for smooth conduct of Ph I-III studies at study management team meetings
• Contribute to the preparation of key documents including investigators brochures, clinical study protocols, study reports, and regulatory briefing documents
• As a lean but growing department, contribute to the establishment of best practices for CP activities – e.g. draft department SOPs, establish quality systems, create plan/report templates, etc

Skills

• An advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated expertise in quantitative PKPD skills
• Basic understanding of drug development and CP principles
• Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc) is required
• Experience of active and effective communication with cross-functional project teams
• Good oral and written communication skills as shown by a publication track record
• Independent worker, self-motivated and self-starter. Works under minimal supervision on reputed company activities. Self monitors reputed company, recognizes delays, and communicates appropriately
• Anticipates problems in the execution of CPP deliverables, displays problem-solving skills to come up with practical and innovative solutions
• Demonstrates leadership courage through effective conflict navigation and resolution
• Strong oral and written communicator; reputed company to summarize clin pharm plans and analyses to cross-functional teams
• Expertise in other modelling software (e.g. GastroPlus, SimCYP, MATLAB, Berkeley-Madonna, etc.) is highly desirable

Benefits

• The opportunity to participate in stock programs
• A performance-based bonus
• A comprehensive benefits package

Company Overview

Company H1B Sponsorship