Associate Director/Director Clinical Pharmacology

Role Summary

Associate Director/Director Clinical Pharmacology provides scientific leadership and strategic direction for Clinical Pharmacology/PK/PD activities across multiple projects. Communicates key Pharmacology information to senior management, regulatory agencies, and external peers; supports drug development planning; leads or guides teams; and ensures high-quality, timely deliverables that align with departmental objectives.

Responsibilities

• Leads Clinical Pharmacology/PK/PD activities and multiple major projects; assists R&D leadership in selecting action plans that meet development objectives.
• Identifies issues and facilitates resolution; conducts risk assessments and contingency planning; ensures projects remain aligned with strategic goals.
• Manages timelines and portfolio opportunities; negotiates with functions to balance time, cost, and quality.
• Provides scientific and strategic consultation to R&D, Regulatory, and management on critical decisions and development plans.
• Evaluates technical and scientific aspects of projects; reviews protocols and reports for regulatory filings; leads regulatory documents writing, submissions, and responses to agency comments.
• Performs due diligence, represents Pharmacology on business development teams, and leads process improvement initiatives.
• Contributes to departmental goals and influences strategic PK/PD decisions; stays current with PK/PD data analysis, modeling, and simulation methods/software.
• May manage personnel, including development, mentoring, and delegation.

Qualifications

• Director, Clinical Pharmacology: PhD with typically 7+ years of experience or PharmD with typically 9+ years of experience in a relevant field; MS or equivalent with 15+ years; BS with 17+ years; relevant field includes PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, or drug metabolism/transporters.
• Associate Director: PhD with typically 4+ years of experience or PharmD with 6+ years; Master’s degree with 12+ years; Bachelor’s degree with 14+ years; relevant field includes PK, PBPK, PK-PD, Pharmacometrics, or systems pharmacology, drug metabolism/transporters.
• Excellent interpersonal skills; ability to interact with functional representatives and KOLs; strategic thinking and enterprise view.
• Proven scientific track record and technical skills to perform the role; leadership competencies across PK/PD, biopharmaceutics, and pharmacometrics; project management and strategic planning capabilities.
• Scientific project leadership or related experience; ability to drive cross-functional alignment and accountability when delegating.

Skills

• PK/PD modeling and simulation; experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology
• Regulatory writing, submissions, and handling regulatory agency inquiries
• Due diligence and business development collaboration
• Strategic planning, risk management, and contingency planning
• Team leadership, mentoring, and cross-functional collaboration
• Project management, scope management, and progress tracking

Education

• Director: PhD or PharmD with extensive experience in pharmacology-related fields; MS/BS with extensive experience as noted in qualifications
• Associate Director: PhD or PharmD with substantial relevant experience; appropriate Master’s or Bachelor’s degrees as specified