Director, Clinical Pharmacology (Oncology)

Role Summary

Communicates and presents key Clinical Pharmacology information and strategy to senior and executive management, regulatory agencies, and external peers. Supports strategic planning for drug development activities to achieve departmental goals. Uses scientific expertise to interpret data and relate implications to management. Serves as liaison to other departments for study and project needs and understands cross-business linkages and the impact of decisions. 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 the selection of action plans that best meets drug development business objectives.
• Identifies issues and help with issue resolution. Conducts risk assessments and assists in development of contingency plans. Assures project remains in alignment with strategic objectives.
• Provides overall timelines to assess portfolio opportunities. Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/performance).
• Provides scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans.
• Responsible for evaluating technical, scientific aspects of all Clinical Pharmacology projects along with management. Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions. Leads Clinical Pharmacology regulatory documents writing, submission and response 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 reviews recommendations with management for approval and sponsorship.
• Contribute to development of departmental goals. Influences strategic PK/PD decisions for the department.
• Performs functions and responsibilities with the highest regard for quality and timeliness. Maintains up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software.
• May manage personnel including development, mentoring, and effective delegation.

Qualifications

• PhD with typically 7+ years of experience or PharmD with typically 9+ years of experience in a relevant field, MS or equivalent education with typically 15+ years of experience; BS or equivalent education and typically 17+ years of experience; (relevant field includes PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, drug metabolism/transporters)
• Excellent interpersonal skills
• Knowledge and experience in multiple therapeutic and/or functional areas
• Experience across range of development phases
• Knowledge of AbbVie and Pharma drug development processes
• Must have demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple projects
• Scientific project leadership or related experience
• Project management skills such as scope management, progress tracking/driving as well as time management
• Participates in initiatives and advancement of Clinical Pharmacology
• Key Leadership Competencies:
  • Knows the business and the cross-functional contributions needed to deliver results
  • Persistent and resilient finds the way to move good ideas forward
  • Acts respectfully yet courageously
  • Connects unrelated concepts, generates original or unique ideas
  • Influences colleagues to achieve cross-functional alignment
  • Communicates openly and honestly with all colleagues
  • Manages conflict and difficult conversations in a constructive, transparent way

Additional Requirements

• This is a hybrid opportunity that requires onsite 3x/week