Group Director, Clinical Pharmacology & Quantitative Pharmacology, Oncology

Role Summary

Lead a dynamic team of Clinical Pharmacologists (CP) and Clinical Pharmacometricians (PMx) in Boston, MA, with line management and project accountability. Responsible for recruitment, development, and retention of staff to build a science-driven, business-focused CPQP team, reporting to the TA Head. Collaborate with CPQP leadership to implement state-of-the-art Clinical Pharmacology and Model-Informed Drug Development (MIDD) approaches, influence study designs and decision making, and manage external collaborations and vendor relationships. Lead or support local and global initiatives related to science, portfolio, and harmonization.

Responsibilities

• Lead a team of CP and PMx scientists delivering quality clinical pharmacology input to projects from pre-CDID to life-cycle management (LCM)
• In close collaboration with the CPQP TA Head and other CPQP line managers be accountable for resource management, providing flexible, competent and responsive service with appropriate quality and speed according to business needs; continuously enhance productivity and cost efficiency where relevant
• Support the TA Head in development of strategy, in scientific operations and business management
• Act as delegate for the TA Head at functional LT meetings, Clin Pharm review Board, governance, and other TA interactions, as necessary
• Act as project Clinical Pharmacologist as required leading development and implementation of the clinical pharmacology strategy
• Accountable for developing a culture supportive of MIDD approaches across TA influencing key partners, stakeholders and regulators of its value and application
• Contribute to ensure a positive collaborative culture and dialogue with key partner functions such as Early and Late TA clinical organisations, Biostatistics, DMPK and Biosciences, Translational medicine, Pharmaceutical Sciences and Regulatory affairs
• Scientific and strategic input into pre-clinical, clinical, and post-approval development plans across TA
• Accountable for oversight, support and delivery of scientific and strategic modeling work related across TA in both early and late development
• Support and review evaluation of candidates for in/out-licensing
• Contribute and lead within and cross-TA peer review
• Provide mentoring within and across TA
• Support and contribute to the learning development for TA providing training and knowledge sharing
• Monitoring external and internal environment in terms of relevant new methodologies and applications
• Increase AZ profile externally in the area of CPQP by speaking at external events, by publication in recognized external journals and representing CPQP at strategic cross-industry and academic initiative and consortia as necessary
• Ensure CPQP contributions for TA are aligned with current regulations and compliant with the principles of GCP and GxP

Qualifications

• Required: Demonstrated broad translational and clinical development experience exemplified by a minimum of 10 years international drug development or equivalent experience (early and late clinical)
• Preferred: PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience
• Required: Can develop people, drives performance, holds self and others accountable
• Required: Record of building successful internal/external partnership and collaboration relationships, demonstrating cultural sensitivity and awareness
• Required: Experience of leading teams
• Required: Strong leadership capabilities including influencing skills
• Required: Experience in mentoring and developing others
• Required: Conceptual, analytical and strategic thinking
• Required: International scientific reputation gained from scientific publishing in the field of quantitative clinical pharmacology
• Required: Demonstrated ability to identify, develop and execute strategic CPQP activities
• Required: Relevant TA disease domain knowledge
• Required: Relevant regulatory experience (written/oral)
• Required: A demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to CPQP
• Preferred: Experience in several large pharma organisations