Director /Senior Director Clinical Pharmacology

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Director / Senior Director of Clinical Pharmacology to build and lead the Clinical Pharmacology function at Samumed.
  • The position will be responsible for the design and implementation of clinical pharmacology components of development programs across therapeutic areas.
  • The title will be dependent upon experience.
  • This is a full-time position in the company’s San Diego headquarters.

Specific Responsibilities

  • Implementing model-based drug development using quantitative approaches to address complex questions arising during drug development
  • Building a fit-for purpose-clinical pharmacology group using internal and contract resources as appropriate
  • Providing the clinical pharmacology components of Clinical Plans and providing clinical pharmacology expertise at the project and study level
  • Directing all relevant PK-PD analyses
  • Providing recommendations for clinical doses and dose regimens (including drug interaction advice, food effects, special populations.) to the clinical development teams and in regulatory submissions
  • Leading clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings. Leading the resolution of clinical pharmacology queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries
  • Providing Clinical Pharmacology expertise to Discovery. During the pre-clinical stages of drug development, working with Research to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exist to underwrite human administration

Requirements

  • PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or other suitable post-graduate qualification
  • 5-15 years of industry experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics
  • Excellent oral and written communication skills
  • Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment

Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.