Executive Director, DMPK

Role Summary

Executive Director, DMPK — Leads the Preclinical Pharmacokinetics function within Preclinical Development, providing scientific leadership and strategic direction for the identification and characterization of clinical candidates with acceptable drug development characteristics. Plays a key role in discovery and advancement of development compounds and interfaces with internal and external colleagues to ensure timely dissemination of Preclinical Pharmacokinetics.

Responsibilities

• Provides strategic, functional leadership and oversight to the Preclinical Pharmacokinetic function within Preclinical Development
• Develops and enables departmental strategies to evaluate Preclinical Pharmacokinetics, including training, techniques, and equipment updates
• Leads and manages conduct, interpretation, and reporting of preclinical pharmacokinetic studies
• Collaborates with Research and Preclinical Development to establish lead candidate characteristics, testing schemes, and study reports
• Designs and conducts Preclinical Pharmacokinetic and Toxicokinetic studies in support of clinical development compounds
• Oversees preparation of Preclinical Pharmacokinetic sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.)
• Leads/participates in research-stage and development-stage program teams at strategic and tactical levels
• Prepares data summaries and presents results to peers, Management Committee, and regulatory agencies
• Prepares SOPs to guide Preclinical Pharmacokinetics activities
• Performs other duties as assigned

Qualifications

• Bachelor's in chemistry, life sciences or closely related discipline with 17+ years of pharmaceutical/biotech experience and extensive management experience; experience with CROs; IND/CTD/NDAs/MAAs; experience with in silico modeling (beneficial) OR
• MS in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline with 15+ years of similar experience
• PhD in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline or PharmD with 12+ years of similar experience
• Demonstrated leadership of a Preclinical Pharmacokinetic function
• Extensive experience managing preclinical Contract Research Organizations
• Excellent knowledge of preparation of INDs, CTAs, NDAs, and MAAs
• Working knowledge of in silico modeling and simulation tools
• Proactive, innovative, with strong problem-solving skills
• Regulatory guidance awareness
• Trusted advisor across the company; potential external expert
• Strategic, cross-functional collaboration, matrix environment experience
• Excellent written, presentation, and verbal communication skills
• Exceptional leadership, coaching, and employee development skills
• Ability to negotiate and influence others at all levels of the organization

Skills

• Strategic leadership in Preclinical Pharmacokinetics
• Regulatory document preparation (IND, NDA, MAAs)
• Cross-functional collaboration and program leadership
• Data interpretation and presentation to management and regulatory bodies
• In silico modeling and simulation tools
• SOP development and operational planning

Education

• Bachelor's degree in chemistry, life sciences or related field; or
• MS or PhD in Pharmacokinetics, Pharmaceutical Sciences or related discipline; or
• PharmD with relevant experience

Additional Requirements

• Travel requirements not specified in provided description
• Physical demands not specified in provided description