Senior Director Dmpk

Overview

• Lead DMPK strategies to advance drug candidates from discovery to development stages.
• Develop comprehensive DMPK packages to enable successful drug registration.
• Provide strategic and technical expertise across multiple programs.
• Collaborate with multidisciplinary teams to achieve project objectives.
• Contribute to the growth and mentorship within the department.
• Maintain scientific visibility through publications and presentations.
• Stay updated with advancements in DMPK research and integrate emerging science.
• Foster a culture of innovation, teamwork, and accountability.

Key Responsibilities & Duties

• Lead IND- and NDA-enabling ADME work and establish in vitro to in vivo correlations.
• Analyze preclinical pharmacokinetic and pharmacodynamic data to inform drug development.
• Collaborate with Discovery teams to evolve translational ADME strategies.
• Partner with Clinical Pharmacology to ensure seamless molecule transitions to development.
• Prepare high-quality regulatory documents, including IND, CTA, and NDA filings.
• Support functional area reviews for due diligence evaluations.
• Conduct scientific presentations to management and collaborators.
• Comply with health and safety policies and laboratory practices.

Job Requirements

• PhD in Pharmacokinetics, Drug Metabolism, or Pharmaceutical Sciences.
• Minimum 12 years of relevant DMPK experience in the pharmaceutical industry.
• Expert knowledge of in vitro and in vivo ADME studies.
• Experience managing external DMPK work at CROs.
• Extensive experience in physiologically-based modeling and simulations.
• Experience with IND/NDA/BLA submissions and global marketing applications.
• Strong leadership and decision-making abilities.
• Excellent collaborative verbal and written communication skills.