Senior Director, Clinical Pharmacology and Quantitative Sciences

7 days ago


Plainsboro, New Jersey, United States Genmab Full time
About the Role

We are seeking a highly experienced and skilled Senior Director to lead our Clinical Pharmacology and Quantitative Sciences team at Genmab. As a key member of our Translational and Quantitative Sciences Leadership Team, you will be responsible for driving critical decisions across the entire spectrum of drug development, from Discovery to Late Clinical Development and beyond.

Key Responsibilities
  • Build, oversee, and lead delivery of pre-clinical and clinical pharmacology teams across programs and processes, ensuring timely and budget-friendly execution.
  • Manage a team of 25+ scientists within Clinical Pharmacology and Quantitative Sciences, comprising Translational and Quantitative Science, Quantitative Systems Pharmacology, Clinical Pharmacology & Pharmacometrics groups.
  • Define long-term strategy for clinical pharmacology and quantitative sciences across all business areas, based on understanding of strategic objectives and enterprise-wide implications.
  • Manage pre-clinical activities for drug candidates through IND enabling studies in close collaboration with Translational Research, Toxicology, DMPK, and other functions.
  • Manage clinical pharmacology, QSP, and pharmacometrics activities of clinical candidates through BLA submission and beyond in close collaboration with multi-disciplinary teams.
  • Lead and oversee development and implementation of clinical pharmacology and quantitative sciences systems/processes and 'best practices' for effective delivery and drive compliance.
  • Provide strategic and tactical leadership across all clinical pharmacology and quantitative sciences operations, including governance oversight, functional risk management, and resolution of critical systemic issues.
  • Drive and foster innovation and adoption of emerging technologies and approaches in line with long-term functional/organizational roadmap.
  • Engage in strategic communication with board, executive leadership, cross-functional leadership, and external stakeholder networks to optimally influence organizational outcomes.
  • Define, monitor, and manage short-term and long-term CPQS budgets for achievement of team goals.
  • Establish and drive people management processes around performance management, engagement, and development, balancing people aspirations and business needs.
About You

We are looking for a highly experienced and skilled Senior Director with a deep understanding of pharmacology and a proven track record of leading teams in a fast-paced, dynamic environment. You should have a strong background in clinical pharmacology, pharmacokinetics, or a related field, with at least 15 years of post-doctoral experience in a relevant technical area. Additionally, you should have 10+ years of people/functional management experience in a relevant area, preferably in the pharma/biotech industry.

Requirements
  • Ph.D. in Clinical Pharmacology, Pharmacology, Pharmacokinetics, or related field with 15+ years of post-doctoral experience in relevant technical area.
  • 10+ years of people/functional management experience in relevant area, preferably in pharma/biotech industry.
  • Broad experience in therapeutic antibody R&D is required; experience in immune-oncology preferred.
  • Working knowledge of Health Authority and Regulatory guidelines for drug development.
  • Significant experience building and executing multi-year strategies; and overseeing multiple global transformational initiatives in complex, dynamic environments.
  • Significant experience with development of overall department/area strategy, operational management of plans with cross-functional teams, as well as budget planning & management.
  • Significant publication record in high-quality journals, references, and external presentations demonstrating relevant experience.
  • Proven performance in earlier role/comparable role including strategic oversight and strategic stakeholder management across levels internally and externally.
  • Experience leading and managing multi-disciplinary teams in a cross-functional and collaborative environment.
  • An innovative attitude coupled with a strong sense of practical execution.
  • The ability to work collaboratively as part of a team in a fast-paced dynamic environment.


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