Director, Clinical Pharmacology

Role Summary

Director, Clinical Pharmacology. This role leads Clinical Pharmacology/PK/PD activities, provides scientific and strategic consultation to R&D and regulatory teams, and may manage personnel and teams to deliver on drug development objectives.

Responsibilities

• Leads Clinical Pharmacology/PK/PD activities and multiple major projects; assists R&D senior management in selecting action plans to meet development objectives.
• Identifies issues, conducts risk assessments, develops contingency plans, and ensures projects align with strategic objectives.
• Provides timelines for portfolio opportunities and negotiates with other functions on outcomes and deliverables to balance time, cost, and quality.
• Provides scientific and strategic consultation to R&D, Regulatory, and management on decisions and development plans.
• Evaluates technical and scientific aspects of AbbVie projects; reviews protocols and reports for regulatory filings; leads regulatory documents writing and responses to regulatory comments.
• Independently conducts due diligence assessments and represents Clinical Pharmacology on business development teams.
• Identifies and develops process improvements; presents recommendations for approval and sponsorship.
• Contributes to departmental goals and influences PK/PD decisions; maintains knowledge of PK/PD data analysis and modeling methods.
• Possibly manages personnel including development, mentoring, and delegation.

Qualifications

• 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 or equivalent with 17+ years (relevant fields include PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, drug metabolism/transporters).
• Excellent interpersonal skills and knowledge across multiple therapeutic/functional areas.
• Experience across a range of development phases; knowledge of AbbVie and pharma drug development processes.
• Demonstrated leadership in PK/PD, biopharmaceutics, and pharmacometrics across multiple projects.
• Scientific project leadership or related experience; strong project management skills (scope, progress tracking, time management).
• Participation in initiatives and advancement of Clinical Pharmacology; strong cross-functional influence and communication skills.

Skills

• PK/PD modeling and simulation; clinical pharmacology regulatory experience; strategic planning.
• Leadership and people management; cross-functional collaboration; effective communication.

Education

• PhD or PharmD with extensive relevant experience as described above; additional advanced certifications as applicable.

Additional Requirements

• Hybrid work onsite 3x/week in Lake County.