Senior Director Dmpk

Overview

• Drive strategic leadership in DMPK to advance drug candidates from discovery to development stages, ensuring robust pharmacokinetic and pharmacodynamic profiles.
• Develop and implement innovative DMPK strategies to support regulatory submissions and successful drug registration.
• Collaborate with multidisciplinary teams to integrate DMPK insights into project objectives and deliverables.
• Provide mentorship and guidance to foster growth within the DMPK department.
• Maintain scientific visibility through publications, presentations, and active engagement in the research community.
• Stay abreast of advancements in DMPK research and apply emerging science to enhance drug development processes.
• Promote a culture of innovation, collaboration, and accountability within the organization.

Key Responsibilities & Duties

• Lead IND- and NDA-enabling ADME studies, establishing correlations between in vitro and in vivo data.
• Analyze preclinical pharmacokinetic and pharmacodynamic data to inform drug development strategies.
• Collaborate with discovery teams to refine translational ADME approaches for candidate molecules.
• Partner with clinical pharmacology to ensure smooth transitions of molecules into development phases.
• Prepare high-quality regulatory documents, including IND, CTA, and NDA filings, ensuring compliance and accuracy.
• Support due diligence evaluations through functional area reviews and scientific assessments.
• Deliver impactful scientific presentations to internal and external stakeholders, showcasing DMPK contributions.
• Ensure adherence to health and safety policies, promoting best practices in laboratory environments.

Job Requirements

• PhD in Pharmacokinetics, Drug Metabolism, or Pharmaceutical Sciences, with a strong foundation in DMPK principles.
• Minimum 12 years of relevant DMPK experience, with preferred 14 years in the pharmaceutical industry.
• Expertise in in vitro and in vivo ADME studies, including physiologically-based modeling and simulations.
• Proven experience managing external DMPK work at CROs and ensuring quality deliverables.
• Extensive experience with IND/NDA/BLA submissions and global regulatory applications.
• Strong leadership capabilities, with a track record of effective team management and decision-making.
• Excellent verbal and written communication skills, fostering collaboration across multidisciplinary teams.
• Commitment to staying updated with industry trends and advancements in DMPK research.