Associate Director/Director, Clinical Pharmacology

Alternative Resources Company

Associate Director/Director, Clinical Pharmacology

Associate Director/Director, Clinical Pharmacology
 
The Associate Director/Director of Clinical Pharmacology will be accountable for developing and executing clinical pharmacology strategies in collaboration with internal and external partners to advance drug candidates in an efficient and scientifically rigorous manner. The Associate Director/Director will have scientific responsibility for the design, execution, analysis, interpretation and reporting of clinical pharmacology related studies including first-in-human, drug-drug interaction, biopharmaceutics and patient studies. In addition, this person is expected to represent clinical pharmacology in program teams and in regulatory interactions including preparation of regulatory documentation and participation in meetings with regulatory agencies.
 
Responsibilities

  • Independently represent Clinical Pharmacology as a member of program, clinical sub-team, clinical trial working teams by contributing to clinical development strategy, clinical trial design, clinical study protocols, executing and coordinating clinical trial conduct and finalizing clinical study reports
  • Develop and execute program specific Clinical Pharmacology strategy and plan. Align plans with cross functional teams, study teams and DMPK/Clinical Pharmacology senior staff
  • Responsibility for Clinical Pharmacology studies and provide effective Clinical Pharmacology support to patient trials. Lead internal DMPK/Clinical Pharmacology sub-teams to define strategy for compound development
  • Manage CROs for Clinical Pharmacology related studies and activities inclusive of developing study timelines, objectives and budgets; ensuring accuracy of project progress and completion and pro-actively identifying hurdles and providing solutions
  • Actively participate in cross-departmental teams, department-wide initiatives and work streams
  • Present and publish internally and externally as main contributor to enhance visibility the DMPK, Clinical Pharmacology department
 
Requirements
  • PhD in clinical pharmacology, pharmaceutical sciences or related areas such as pharmacokinetics, pharmacology or drug metabolism
  • 8-10 years of relevant experience in clinical drug development
  • Extensive experience in formulating and executing Clinical Pharmacology strategies including design, interpretation and reporting of clinical pharmacology studies is required
  • A working knowledge and previous experience with pharmacokinetic/pharmacodynamics, drug-drug interactions, PKPD data management/analysis, clinical development
  • Broad familiarity with the drug development process, particularly for oncology, is highly desirable as is prior experience working with CROs
  • Excellent interpersonal and communication skills both written and oral are essential to perform in this matrix team environment