Director, Clinical Pharmacology

Role Summary

Directs Clinical Pharmacology strategy and drug development planning, communicates key Clinical Pharmacology information to senior management and regulatory bodies, and leads Clinical Pharmacology and Pharmacometrics teams. Serves as liaison across departments to align study needs and strategic objectives, and oversees cross-functional collaboration to ensure successful project delivery.

Responsibilities

• Independently leads Clinical Pharmacology/PK/PD activities and multiple major projects. Assists R&D senior management in selecting action plans to meet drug development objectives.
• Identifies issues impacting multiple complex projects and leads issue resolution. Conducts risk assessments and develops contingency plans to keep projects aligned with strategic objectives.
• Provides overall timelines to assess portfolio opportunities. Negotiates with other functional areas on project outcomes and deliverables to balance time, cost, and quality.
• Provides expert scientific and strategic consultation to R&D, Regulatory, and management on critical decisions and development plans. Connects scientific, regulatory, and business implications across teams.
• Reviews clinical protocols and scientific reports for regulatory filings; anticipates regulatory questions. Leads regulatory documents writing, submissions, and responses to regulatory agency comments.
• Independently conducts due diligence assessments, summarizes results, and represents Clinical Pharmacology on business development teams.
• Identifies and develops process improvement initiatives and presents recommendations for approval and sponsorship.
• Leads efforts to develop departmental goals and makes strategic PK/PD decisions for the department. Provides leadership on strategic clinical pharmacology and drug development.
• Manages personnel including development, mentoring, and effective delegation. Leads cross-functional teams and manages team performance, mediating conflicts and fostering high-performing teams.

Qualifications

• PhD with typically 9+ years of experience or PharmD with typically 11+ years of experience in a relevant field; Master’s Degree in Science or related field with typically 17+ years; Bachelor’s Degree with typically 19+ years or more of related work. Relevant fields include PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, drug metabolism/transporters.
• Excellent interpersonal skills.
• Advanced knowledge and experience in multiple therapeutic and/or functional areas.
• Experience across a range of development phases.
• Recognized as an expert with global knowledge of drug development processes.
• Demonstrated strong leadership competencies in PK/PD, biopharmaceutics, and pharmacometric activities from planning through completion across multiple complex projects.
• Demonstrated leadership skills with broad scientific and business-oriented focus.
• Demonstrated project management skills including scope management, progress tracking, and people/time management.
• Key contributor to initiatives and advancement of Clinical Pharmacology.
• Key Leadership Competencies: understands cross-functional contributions needed to deliver results; manages conflict constructively; develops direct reports through coaching and stretch assignments; provides transparent feedback; creates an inclusive environment for team success.

Education

• PhD with typically 9+ years of experience or PharmD with typically 11+ years of experience in a relevant field; Master’s Degree in Science or related field with typically 17+ years; Bachelor’s Degree in Science or related field with typically 19+ years or more of related work (relevant fields include PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters).

Additional Requirements

• Hybrid opportunity, 3x/week in Lake County, IL.