Jobs · Analyst · Illinois

Director, Clinical Pharmacology

BioSpace · North Chicago, IL · 5 days ago
AnalystFull-time

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, and eye care, as well as products and services in our Allergan Aesthetics portfolio.

About the role

Communicates and presents key Clinical Pharmacology information and strategy to senior and executive management, regulatory agencies, and external peers. Leads strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives. Utilizes scientific expertise to provide appropriate interpretation of data and relates implications of results to management. Serves as liaison to other departments/divisions for any study or project needs. Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions. Leads teams within Clinical Pharmacology and Pharmacometrics and is accountable for effective performance of the teams.

Responsibilities

  • Independently leads Clinical Pharmacology, PK, and PD activities and multiple major projects.
  • Assists R&D senior management in selecting action plans that best meet drug development business objectives.
  • Identifies issues impacting multiple complex projects and leads issue resolution.
  • Conducts risk assessments and leads the function in development of contingency plans.
  • Assures projects remain in alignment with strategic objectives and 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 expert scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans.
  • Connects scientific, regulatory, and business implications from multiple teams.
  • Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions.
  • Critically evaluates technical and scientific aspects of all AbbVie projects along with Clinical Pharmacology management.
  • Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions.
  • Leads Clinical Pharmacology regulatory document 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.
  • 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 teams within the department, across Clinical Pharmacology, and across functions.
  • Actively manages project team behaviors, mediates internal team disputes, and facilitates establishment of healthy and high-performing teams.

Qualifications

  • PhD with typically 9+ years of experience or PharmD with typically 11+ years of experience in a relevant field (PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, drug metabolism/transporters).
  • Master’s Degree in Science or related field with typically 17+ years of related work, or Bachelor’s Degree in Science or related field with typically 19+ years of related work.
  • 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 AbbVie and Pharma drug development processes.
  • Demonstrated strong leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple complex projects.
  • Demonstrated leadership skills with broad scientific and business-related orientations.
  • Demonstrated project management skills such as scope management, progress tracking/driving, as well as people and time management.
  • Key contributor to initiatives and advancement of Clinical Pharmacology.

This is a hybrid opportunity, requiring presence in the Lake County, IL office 3 times per week.

Key Leadership Competencies

  • Knows the business and the cross-functional contributions needed to deliver results.
  • Manages conflict and difficult conversations in a constructive, transparent way.
  • Develops direct reports and capable successors through coaching, stretch assignments, and learning opportunities.
  • Respectfully provides transparent, accurate, and timely feedback to help direct reports improve performance.
  • Creates an inclusive environment where all direct reports can succeed.

Benefits

  • Comprehensive package including paid time off (vacation, holidays, sick).
  • Medical, dental, and vision insurance.
  • 401(k) retirement plan.
  • Eligibility to participate in short-term and long-term incentive programs.

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