Group Director, Clinical Pharmacology & Quantitative Pharmacology, Oncology

Job Title: Group Director, Clinical Pharmacology & Quantitative Pharmacology

Location: Boston, MA
 

Introduction to role:
Are you ready to lead a dynamic team in the pursuit of scientific excellence?

This is a line management role which also includes project accountabilities, as well as responsibilities to lead initiatives related to scientific, strategic and/or improvement initiatives, either at therapy area, functional or cross-functional levels. The individual will lead a team of Clinical Pharmacologists (CP) and Clinical Pharmacometricians (PMx) and will be responsible for recruitment, retainment, and development of staff to establish a dynamic, innovative, business-focused, and science-driven team. This individual will report to the TA Head, act as their delegate where necessary, and work closely with members of the TA CPQP leadership team and organisation to ensure consistent and valued CPQP contributions across the TA portfolio. 
 

The TA Group Director will also have project accountabilities and work closely with clinical teams to ensure state-of-the-art Clinical Pharmacology and Model-Informed Drug Development (MIDD) approaches are implemented to influence designs and internal/external decision making. The role will develop innovative strategies and/or lead groups which utilise foundational and cutting-edge model-informed drug development, in combination with business domain knowledge, to generate impactful business and scientific insights. The role will be responsible for influencing senior internal stakeholders and manage external collaborations and vendors to deliver effective solutions. The individual will also lead or support local/global initiatives in areas related to science, portfolio, harmonization etc.   

Accountabilities:

• 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.  

Essential Skills/Experience:

• Demonstrated broad translational and clinical development experience exemplified by a minimum of 10 years international drug development or equivalent experience (early and late clinical) 

• PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required  

• Can develop people, drives performance, holds self and others accountable 

• Record of building successful i