[Remote] Remote Director, Clinical Pharmacology

Note: The job is a remote job and is open to candidates in USA. Allucent helps biopharmaceutical companies navigate clinical trials and develop therapies. The Director, Clinical Pharmacology independently leads clinical pharmacology activities and provides strategic advice, scientific oversight, and review of clinical and regulatory documents for clients.

Responsibilities

• Take independent leadership in providing strategic clinical pharmacology advice to clients within a cross-functional team, covering overall drug development activities
• Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies (including renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and offer recommendations to enhance pharmacokinetic sampling and dosing strategies
• Thoroughly assess the technical and scientific components of PK and PK/PD projects and programs for clients, with knowledge of noncompartmental analysis as well as population PK, PBPK, and QSP modeling
• Oversee the development of statistical and PK analysis plans, standalone PK/PD reports, and PK/PD sections of clinical study reports, and take the lead in reviewing clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology and safety sections of NDAs, Investigator Brochures, FDA briefing packages, and other clinical and regulatory documents

Skills

• PharmD or Ph.D. in a relevant area
• 8+ years of relevant work experience
• Strong written and verbal communication skills including good command of English language
• Client focused
• Ability to work in a fast-paced environment

Benefits

• Comprehensive benefits package per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program

Company Overview

Company H1B Sponsorship