Senior Director, Clinical Pharmacology

Senior Director, Clinical Pharmacology - Permanent - Remote

Proclinical is seeking a Senior Director in Clinical Pharmacology to lead and drive the pharmacokinetic and pharmacodynamic aspects of drug development, particularly in sleep disorders. This role involves guiding clinical pharmacology activities across multiple programs, providing technical expertise for regulatory interactions, and contributing to other projects as needed. The position requires strong leadership, communication, and relationship-building skills to achieve results in a collaborative environment.

Skills & Requirements:

• Advanced degree in pharmacokinetics/pharmacodynamics or related field.
• Experience in clinical pharmacology within the pharmaceutical industry.
• Expertise in clinical pharmacology strategies and regulatory submissions.
• Proficiency in PK/PD analysis and clinical pharmacology software tools.
• Knowledge of study protocols and PK/PD modeling for sleep disorders.
• Understanding of US and EU regulatory requirements.
• Ability to work in a matrix team environment and influence with data-driven insights.
• Strong interpersonal and communication skills.

The Senior Director, Clinical Pharmacology will:

• Lead and manage clinical pharmacology strategies for assigned projects.
• Plan and direct studies in collaboration with internal and external partners.
• Utilize PK/PD modeling to support dose selection and safety assessments.
• Oversee vendors to ensure accurate PK data collection.
• Apply modeling techniques to optimize study design and data interpretation.
• Draft relevant sections of clinical study protocols and regulatory documents.
• Present findings and recommendations to stakeholders.
• Collaborate across disciplines involved in drug development.
• Coordinate with global team members and vendors through virtual and in-person interactions.
• Author scientific publications and present at conferences.
• Ensure high-quality data delivery through effective vendor oversight.