Director, Clinical Pharmacology

Role Summary

Director, Clinical Pharmacology – Communicates key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Supports strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives. Utilizes scientific expertise to interpret data and relate implications to management. May lead teams within Clinical Pharmacology and Pharmacometrics and be accountable for their performance.

Responsibilities

• Leads Clinical Pharmacology/PK/PD activities and multiple major projects. Assists R&D senior management in selecting action plans that best meet drug development objectives.
• Identifies issues and facilitates issue resolution. Conducts risk assessments and contributes to contingency plans. Ensures projects remain aligned with strategic objectives.
• Provides overall timelines to assess portfolio opportunities. Negotiates with other functional areas on outcomes and deliverables to meet competing demands (time, cost, quality).
• Provides scientific and strategic consultation to R&D, Regulatory, and senior management on critical decisions and development plans.
• Evaluates technical and scientific aspects of AbbVie projects alongside Clinical Pharmacology management. Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions. Leads regulatory documents writing, submission, 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, presenting recommendations for approval and sponsorship.
• Contributes to development of departmental goals. Influences strategic PK/PD decisions for the department.
• Maintains up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software; performs duties with high quality and timeliness.
• May manage 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 typically 15+ years; BS or equivalent with typically 17+ years (relevant field includes PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, drug metabolism/transporters).
• Excellent interpersonal skills.
• Knowledge and experience across multiple therapeutic and/or functional areas; experience across a range of development phases.
• Knowledge of AbbVie and pharmaceutical drug development processes.
• Demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometrics across multiple projects.
• Scientific project leadership or related experience; project management skills including scope management, progress tracking, and time management.
• Participation in initiatives and advancement of Clinical Pharmacology.
• Key leadership competencies: understanding cross-functional contributions, perseverance, respectful and courageous communication, ability to connect concepts, influence for cross-functional alignment, open and honest communication, and constructive conflict management.

Skills

• PK/PD modeling and simulation; clinical pharmacology regulatory strategy; cross-functional collaboration; leadership and people management; strategic planning; due diligence; risk management.

Education

• PhD or PharmD with extensive experience as outlined in Qualifications; advanced degree in a relevant field.

Additional Requirements

• Hybrid role requiring onsite presence 3x/week in South San Francisco.