Senior Director Dmpk

Overview

• Lead the strategic direction of DMPK to enhance drug development and regulatory success, ensuring innovative solutions for therapeutic candidates.
• Collaborate with multidisciplinary teams to integrate DMPK insights into project strategies and optimize outcomes effectively.
• Provide mentorship and leadership to develop expertise and foster growth within the DMPK team.
• Engage with the scientific community through publications and presentations to maintain visibility and credibility.
• Stay updated on advancements in DMPK research to apply cutting-edge methodologies and drive innovation.
• Promote a collaborative and innovative culture within the organization to enhance team performance and outcomes.
• Ensure compliance with industry standards and regulations to uphold quality and safety in all processes.

Key Responsibilities & Duties

• Lead ADME studies to support IND and NDA submissions, ensuring data accuracy and regulatory compliance.
• Analyze pharmacokinetic and pharmacodynamic data to inform strategic decisions in drug development.
• Collaborate with discovery teams to refine translational approaches for candidate molecules.
• Partner with clinical pharmacology to ensure seamless transitions into development phases.
• Prepare high-quality regulatory documents, including IND, CTA, and NDA filings, to support submissions.
• Conduct due diligence evaluations through scientific assessments and reviews to inform decisions.
• Deliver impactful presentations to stakeholders, showcasing DMPK contributions and insights.
• Ensure adherence to safety policies and promote best practices in laboratory environments.

Job Requirements

• PhD in Pharmacokinetics, Drug Metabolism, or Pharmaceutical Sciences is required.
• Minimum of 12 years of DMPK experience, with 14 years preferred in the pharmaceutical industry.
• Expertise in in vitro and in vivo ADME studies, including modeling and simulations.
• Proven experience managing external DMPK work at CROs effectively and efficiently.
• Extensive experience with regulatory submissions, including IND, NDA, and BLA filings.
• Strong leadership skills with a track record of team management and strategic decision-making.
• Excellent communication skills to foster collaboration across multidisciplinary teams.
• Commitment to staying updated with industry trends and advancements in DMPK research.