Associate Director Clinical Pharmacology

Highly Competitive
  1. Permanent
  2. Pharmacology
  3. Germany
Mainz, Germany
Posting date: 11 Dec 2023
57888

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Proclinical are partnering with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis. The opening position is for an Associate Director.

Responsibilities:

  • Guide the analysis, comprehension and reporting of clinical pharmacokinetic data.
  • Collaborate with research leads for the design and data analysis/comprehension of pharmacokinetic and pharmacodynamics (pd) facets of preclinical studies.
  • Offer ground-breaking clinical pharmacology and pharmacometrics contributions in regulatory documents such as IC, regulatory briefing book, NDA/BLA, etc.
  • Supply translational PK knowledge and representation at international health authority meetings.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Educates to an advanced degree level in a pharmaceutics, pharmacokinetics, pharmacology, pharmacometrics, or similar field, or Pharm.D. or M.D. with demonstrable pertinent work experience.
  • Demonstrable experience within a biotech or pharmaceutical organisation which involves a comprehension of early and late drug development procedures from IND via NDA/BLA.
  • Familiarity with guiding clinical pharmacology actions in drug development programs, from early exploratory studies to Phase 2/3 programs in Oncology and/or Infectious diseases.
  • Acquaintance with translational research and/or pharmacometrics and its application to cancer drug development, including PKPD, exposure response and translational modelling actions to assist with optimal dose and dosing schedule decisions.
  • A background in researching interest and comprehension of PK and PK/PD data in the context of multifaceted biology.
  • A background in oncology and/or infectious diseases would be ideal.
  • Competency in using Phoenix WinNonlin, R, NONMEM, MATLAB or any other pharmacokinetic and modelling software.
  • An organised individual with documentation abilities.
  • Works well independently with ability to be motivated.
  • Presentation and communication skills both verbally and in writing.
  • Capable of serving as a matrix leader.
  • Fluency in the English language.
  • Communication skills both verbally and in writing.

If you are having difficulty in applying or if you have any questions, please contact James Hume at j.hume@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#Scientific

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