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Associate Director, Clinical Pharmacology

Reference Number: 2786
Location: NJ

Our client is a global pharmaceutical company addressing unmet medical needs.  They have asked us to assist them in their search for an Associate Director, Clinical Pharmacology.

The Associate Director, Clinical Pharmacology drives all clinical pharmacologic aspects of multiple projects.  The goal of the Oncology Clinical Pharmacology and Translational Medicine group is to provide a high quality, science-based understanding of the pharmacology of drugs in development to permit early and late phase decisions compounds in development by the company.  The incumbent will be responsible for providing clinical pharmacology support to development projects in all stages of clinical development and will serve as a key expert on all clinical pharmacology, pharmacokinetic (PK) and pharmacodynamics (PD) issues.  The incumbent will be also responsible for developing and executing clinical pharmacology strategies, design of clinical pharmacology studies, interpretation of PK/PD data, and contribution to clinical study reports and regulatory documents (Investigator Brochure, Briefing Book etc.).  As a representative of Clinical Pharmacology, the Associate Director will be expected to serve as an SME in Clinical Pharmacology on project teams and in regulatory interactions including the preparation of regulatory documentation and participation in meetings with Health Authorities.  The ideal candidate will be expected to work independently and collaborate on cross-functional project teams (pre-clinical, bioanalytical, modelers, clinicians, clinical research organizations and external collaborators) in support of the broad portfolio of small and large molecule drugs in development.

Major tasks and responsibilities will include:

  • Develops and executes scientifically robust and efficient clinical pharmacology strategies for compound candidates across all phases of development, including life cycle management.
  • Designs and conducts clinical pharmacology and clinical studies required to evaluate and ultimately gain approval of investigational new drugs.
  • Prepares/presents study results in a dynamic and clear manner.
  • Provides clinical pharmacology sections of clinical protocols, clinical study reports, and regulatory documents.
  • Prepares and reviews reports/documents necessary to achieve regulatory approval.
  • Develops Phase 1 – 3 (and post-marketing) Protocols as Study Director or Study Clinical Pharmacologist.
  • Contributes to the drug development process by providing a leadership role on teams (e.g. clinical and pre-clinical sub-teams).
  • Interacts with Regulatory Authorities (from preparing submission documents to actively participating in meetings with those Authorities).
  • Authors assigned sections of regulatory documents.
  • Develops and implements science-based strategic clinical pharmacology plans supporting full development leading to global registration and value-added labeling.

We seek candidates with the following qualifications:

  • PhD, MD/PhD, or equivalent with a minimum of 8 years of industry experience.
  • In-depth knowledge of Oncology clinical development, clinical pharmacology and PK/PD.
  • Significant Clinical Pharmacology training and experience.
  • Prior experience participating in cross-functional project teams.

 

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 2786. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.