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Director Clinical Pharmacology

Reference Number: 3125
Location: Remote

Our client is an emerging pharmaceutical company.  They have asked us to assist them in their search for a Director Clinical Pharmacology.

Major tasks and responsibilities will include:

  • Provides clinical pharmacology expertise on protocol design, clinical study reports, investigator brochures, DSUR’s, and provide scientific expertise in the preparation of clinical pharmacology sections in various regulatory submissions globally.
  • Provides subject matter expertise to support the continued clinical development of the Company’s lead candidate(s).
  • Participates in interdepartmental scientific and clinical activities specific to implementation and conduct of clinical protocols.
  • Works with various in-house functional groups with regards to studies design issues.
  • Directs and/or manages clinical pharmacology functions to ensure adherence to study protocols, regulatory and internal operating procedures, intended timelines and the budget.
  • Provides subject matter expertise in pharmacokinetics data analysis, interpretation and risk assessment on drug candidates in development.
  • Develops strategies for pharmacokinetic analysis in clinical studies, population modelling, dosing and labelling recommendations.
  • Communicates clinical project updates to the Executive Leadership Team and appropriate functional groups.
  • Provides expertise in clinical pharmacology related matters with regulatory authorities including response to questions from regulators, teleconferences, Face-to-face Meetings, Oral Explanations, etc.
  • Provides clinical pharmacology expertise for core drug labelling and approvals.
  • Provides training and education to internal staff and external vendors, sites and investigators.
  • Clinical pharmacology expertise, particularly for study design and data interpretation, risk assessment necessary for preparation and filing of INDs, original and supplemental NDAs.
  • Subject matter expertise in Clinical pharmacology, drug interactions and ADME, bioanalytical needs, and risk assessment.
  • Experience interacting with the FDA and/or EMA on INDs, NDAs, and development programs.
  • Provides scientific and clinical guidance to Clinical Trials Management, Biostatistics and Data Management Drug Safety, Regulatory and Project Management to meet project deliverables and timelines.
  • Expert in clinical pharmacology study design in all phases of pre-approval clinical trials.
  • Understands regulatory guidelines for ADME, DDI, dosing and labelling recommendations.
  • Demonstrates ability to work in a matrix leadership environment.
  • Works effectively with multiple departments.

We seek candidates with the following qualifications:

  • PhD in Pharmacology or Pharmaceutical Sciences or related Sciences or equivalent combination of education with applicable job experience.
  • MD or PharmD with relevant experience will be considered.
  • A minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
  • Extensive experience with regulatory requirements, preparation of the clinical pharmacology sections of NDAs, BLAs, understanding of FDA regulations, GCP and/ SOPs in clinical research within a pharmaceutical or biotech environment or relevant.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3125. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.