Company: Barrington James Clinical
Reference: cs science
Closing Date: 16 May 17
Type: Full Time
Salary (£): Negotiable
We are seeking a highly motivated and scientifically rigorous individual yo lead PKDM efforts. The successful candidate will report to Head of Pre-clinical and Clinical Development and will be an integral part of the Research and Development team.
Summary of Role
The Head of Pharmacokinetics and Drug Metabolism (PKDM) is responsible for providing PKDM strategy, expertise, representation and resources to all program teams and management across all therapeutic areas and stages of development. S/he will provide leadership and oversight of the PKDM group and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to generate and integrate PK and ADME data leading to the estimation of safe and efficacious first in human clinical dose and regimen for novel therapeutics, as well as predicted clinical PK and PK/PD profiles and optimal posology. In addition, the PKDM organization will be responsible for design, analysis and reporting for all phase-appropriate and registration-enabling studies (eg, bioavailability, ADME, bioequivalence, DDI, food-effect). The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with program-related PKDM issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of PKDM develops and implements strategic plans for preclinical and clinical pharmacokinetics and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for PKDM studies and other activities in support of our clients portfolio programs, and provide submission-ready documentation for the PKDM components of regulatory submissions.
PhD in a related subject.
8-10+ years industry-related experience in regulatory PKDM working within the biotechnology or pharmaceutical industry
Extensive training in pharmacokinetic analysis and biostatistics, including construction of PK and PK/PD models, simulation, and prediction of first-in-human and human equivalent doses is required.
Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenge, new ideas, information, situations or criticism.
Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
Fluency in written and spoken English is required.
Domestic and occasional international travel required.
Please direct all questions (if necessary) to “Chris” at firstname.lastname@example.org cswain (at) barringtonjames (dot) com alongside a copy of your CV.
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