Director of Clinical Pharmacology

Director, Clinical Pharmacology

Location: San Francisco Bay, Chicago, Boston
Industry: Global Biopharmaceutical | Oncology, Immunology, Neurology

Overview

Our client, a global biopharmaceutical leader, is seeking a Director of Clinical Pharmacology to drive strategic and scientific leadership across multiple development programs. This role offers the opportunity to shape clinical pharmacology strategies, contribute to regulatory submissions, and lead cross-functional initiatives that impact the future of innovative therapies across therapeutic areas such as oncology, immunology, neuroscience, and more.

Position Summary

The Director will lead clinical pharmacology and PK/PD activities across several major programs, providing scientific and strategic consultation to internal stakeholders and regulatory bodies. This individual will play a key role in shaping development plans, guiding regulatory strategy, and mentoring team members while ensuring alignment with broader R&D objectives.

Key Responsibilities

• Lead clinical pharmacology strategy and execution across multiple programs
• Present key data and strategy to senior leadership, regulatory agencies, and external collaborators
• Provide scientific interpretation of PK/PD data and modeling results to inform development decisions
• Oversee regulatory documentation and responses related to clinical pharmacology
• Conduct due diligence assessments and represent the function in business development activities
• Collaborate cross-functionally with R&D, Regulatory, Clinical Development, and other stakeholders
• Identify and implement process improvements and contribute to departmental goal setting
• Stay current with advancements in modeling, simulation, and regulatory science

Qualifications

• PhD with typically 7+ years of experience or Pharm D with typically 9+ years of experience in a relevant field, MS or equivalent education with typically 15+ years of experience; BS or equivalent education and typically 17+ years of experience; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
• Proven leadership in cross-functional project teams and regulatory strategy
• Experience across multiple therapeutic areas and development phases
• Strong knowledge of modeling and simulation tools and regulatory expectations
• Excellent communication, collaboration, and strategic thinking skills
• Demonstrated ability to influence across functions and manage complex projects