• Job Description

  Req#: dt9917
  Summary:

  The Associate Director of Clinical Pharmacology supports a growing clinical portfolio focused on TPD therapeutics, with responsibilities across clinical pharmacokinetics (PK), pharmacodynamics (PD), and overall clinical pharmacology strategy. This role is integral to phase 1 development and an active preclinical pipeline, providing key PKPD guidance to project teams and conducting analyses that inform dose selection and drug development decisions.
  

  Key Responsibilities:

  • Lead the analysis, interpretation, and reporting of clinical pharmacokinetic and pharmacodynamic data to guide development decisions.
  • Conduct model-based analyses for dose escalation and selection in ongoing clinical studies.
  • Integrate clinical and preclinical findings to inform development strategies and broader research initiatives.
  • Provide PKPD input for regulatory documents, including IND, CTA, and NDA submissions.
  • Design and oversee clinical pharmacology studies, ensuring data quality and relevance.
  • Network with external consultants, CRO partners, and academic sites to address clinical pharmacology challenges.
  • Prepare relevant documents or sections of clinical protocols, Investigator Brochures, and Clinical Study Reports for Clinical Pharmacology studies.
  • Collaborate closely with internal teams, including Research, Bioanalytical, Clinical, Regulatory, and Project Management functions.

  
  Qualifications:

  • PharmD or PhD in Pharmacokinetics, Pharmacology, Pharmaceutics, or related field with 4-6 years of pharmaceutical industry experience.
  • Strong knowledge of PK/PD principles, ADME concepts, and clinical pharmacology.
  • Proficiency in pharmacokinetic and modeling software, such as Phoenix WinNonlin, NONMEM, or R.
  • Excellent communication, presentation, and interpersonal skills, with the ability to work in a fast-paced, matrixed team environment.

  Department: Direct Clients
  This is a full time position
  

• About the company

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