Associate Director, Clinical Pharmacology

• Act as Clinical Pharmacology representative on Clinical Sub Teams, Development Teams, and other multifunctional teams
• Provide clinical pharmacology expertise, leadership, and project deliverables
• Design and execute clinical pharmacology plans and implement best practices
• Collaborate with other disciplines to establish preclinical PK/PD knowledge and predictive models before first-in-human studies
• Plan and oversee project-level clinical pharmacology activities, including clinical development plans and PK/PD, immunogenicity, and biomarker strategies
• Plan and oversee study-level activities including protocol authoring, clinical phase oversight, and reporting
• Ensure appropriate dose-range finding strategies and optimize doses and dosage regimens
• Design and implement end-to-end model-informed drug discovery and development plans
• Use innovative analytical methods to integrate PK, PD, patient, and disease knowledge
• Contribute to regulatory documents, including briefing documents, regulatory queries, Investigator’s Brochures, INDs, and NDA/MAAs
• Develop new methodologies through internal and external collaborations
• Coach less experienced colleagues and team members
• Monitor literature, regulatory guidelines, internal guidance, and SOPs
• Influence the external environment through publications, presentations, scientific societies, and industry consortia

• M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or a related discipline
• 1+ year of industry experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics/systems pharmacology
• Pharm.
  
  D. or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or a related discipline
• 5+ years of industry experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics/systems pharmacology
• Strong quantitative skills and expertise in mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations
• Experience using NONMEM, R, or similar tools
• Intimate knowledge of drug development and quantitative pharmacology approaches to knowledge integration
• Excellent written and verbal communication skills
• Demonstrated presentation skills
• Ability to attend global meetings periodically across different time zones
• Candidates must be authorized to be employed in the U.S. by any employer
• Permanent work authorization in the United States required
• U.S. work visa sponsorship is not available now or in the future

Demonstrates expertise in clinical pharmacology, including pharmacokinetics and pharmacometrics, with a strong focus on model-informed drug discovery and development. Proven ability to lead cross-functional teams and contribute to regulatory submissions while ensuring compliance with industry standards.

• Clinical Pharmacology Expertise
• Pharmacokinetics Modeling
• NONMEM Proficiency
• Regulatory Document Contribution
• Quantitative Skills

• Pharmacokinetics
• Pharmacometrics
• Clinical Pharmacology
• Mechanistic PK/PD Modeling
• Population Modeling
• Clinical Trial Simulations
• Dose-Range Finding Strategies
• Analytical Methods Integration
• Protocol Authoring
• Biomarker Strategies

• Excellent Communication Skills
• Presentation Skills
• Coaching and Mentoring

• M.D.
• Ph.D.
• Pharm.
  
  D.

• Clinical Development Plans
• PK/PD
• Immunogenicity
• Biomarker Strategies
• Regulatory Guidelines
• SOPs
• First-in-Human Studies
• Global Meetings

• NONMEM
• R