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.