AbbVie

Director, Clinical Pharmacology

Employer
AbbVie
Location
South San Francisco, California
Posted
Jul 07, 2021
Ref
2107763
Required Education
Doctorate/PHD/MD
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

  • Provides expert scientific and strategic consultation to R&D, Regulatory Affairs, Regulatory Agencies, and all levels of management on critical decisions and development plans for multiple projects across multiple therapeutic areas. Leads development of modeling and simulation.
  • Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions. Complies with procedures set forth in: Departmental Guidelines, Relevant IQS documents, Study protocols and other directives issued by the management regarding clinical/ preclinical studies.
  • 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. Maintains through and in-depth knowledge of PK/PD and drug development literature across multiple therapeutic areas.
  • Provides leadership and develops strategic Drug Development recommendations to therapeutic areas. Leads teams within department, across CPPM and across functions. Responsible for leadership of cross-functional teams. Responsible for mentoring departmental personnel. Attends regulatory meetings
  • Manages personnel, including development, mentoring, and effective delegation. Supervises exempt and/or non-exempt direct reports. Identifies and leads efforts designed to support the development of individuals.
  • Independently leads PK/PD activities and multiple self-initiated major projects. Assists R&D senior management in the selection of action plans that best meets clinical pharmacology and drug development business objectives.
  • Anticipates and leads issue resolution. Assures alignment of multiple projects 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).
  • Responsible for leading efforts to develop departmental goals. Makes strategic PK/PD decisions for the department and division. Provides leadership to the department on strategic drug development business issues.
  • Establishes and manages tools & processes needed to ensure employee proficiency with departmental systems, procedures, tools and guidelines (e.g., training, mentoring, and effective delegation). Responsible for overseeing operations activities/ projects managed by others within department. Responsible for short- and long-term plans and management of implications of alternative scenarios.
  • Actively manages project team behaviors, mediates team disputes, and facilitates establishment of healthy and high performing teams. Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship. Conducts risk assessments and leads the function in development of contingency plans.

Qualifications
  • PhD with 9+ years of experience or Pharm D with 11+ years of experience in a relevant field*; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
  • Team, drug development, and scientific project leadership or related experience.
  • Advanced project leadership experience of 9 + years related to clinical research, drug development and department operations. Proven record of successful projects.
  • Recognized as an expert with global knowledge of AbbVie and Pharma drug development processes
  • Recognized leader in complex scientific analyses, business-related procedures, and leadership of multiple projects.
  • Demonstrated leadership skills with broad scientific, strategic and business-related orientations.
  • Requires multi-faceted, broad-based experience in multiple functions. Considered to have in depth knowledge of drug development issues and business needs.

Significant Work Activities
N/A
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.