Group Director, Clinical Pharmacology - Oncology
3 days left
- Experience Level
- Senior Management
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe!
As the Oncology Group Director within Clinical Pharmacology & Quantitative Pharmacology (CPQP) you will be responsible for line management, project accountabilities, leading initiatives related to scientific, strategic and/or improvement initiatives, either at therapy area (Oncology), functional or cross-functional levels. You 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 indivdiual will report to the US Oncology Head, act as their delegate where necessary, and work closely with members of the Oncology CPQP leadership team and organisation to ensure consistent and valued CPQP contributions across the Oncology portfolio.
The Oncology 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. You will also lead or support local/global initiatives in areas related to science, portfolio, harmonization etc.
- 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 Oncology 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 US Oncology Head in development of strategy, in scientific operations and business management
- Act as delegate for the US Oncology Head at functional LT meetings, Clin Pharm review Board, governance, and other Oncology 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 Oncology 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 Oncology 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 Oncology
- With the Oncology director PMx accountable for oversight, support and delivery of scientific and strategic modeling work related across Oncology in both early and late development
- Support and review evaluation of candidates for in/out-licensing
- Contribute and lead within and cross-Oncology peer review
- Provide mentoring within and across Oncology's
- Support and contribute to the learning development for Oncology 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 Oncology are aligned with current regulations and compliant with the principles of GCP and GxP.
Education and Experience Required:
- PhD degree preferred; M.Sc. or Pharm.D with relevant experience 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)
Required Skills: Abilities:
- Can develop people, drives performance, holds self and others accountable
- Record of building successful internal/external partnership and collaboration relationships, demonstrating cultural sensitivity and awareness
- Experience of leading teams
- Strong leadership capabilities including influencing skills
- Experience in mentoring and developing others
- Conceptual, analytical and strategic thinking
- International scientific reputation gained from scientific publishing in the field of quantitative clinical pharmacology
- Demonstrated ability to identify, develop and execute strategic CPQP activities
- Relevant Oncology disease domain knowledge
- Relevant regulatory experience (written/oral)
- A demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to CPQP
- Experience in several organisations
This position is in Gaithersburg, MD
The AstraZeneca Gaithersburg campus employs more than 3,500 specialists in our field and is only a short drive from Washington, DC. This green, sustainable, modern, vibrant scientific campus is where we host some of the most cutting-edge technology and lab spaces. Newly designed, state of the art research spaces and open seating floor plans are just a couple of ways we work cross functionally and collaboratively.
The Gaithersburg campus also provides an award winning café, free garage parking with electric car charging stations, bike racks, free fitness center to include classed and personal training game rooms, outdoor patio, bocce ball court, arcade games and game tables, recharge Pod's, library, walking trails, onsite dry cleaning pickup, haircutting service, health and wellness center, starbucks café, and much more!
AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It's our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees' varying needs, and offers valuable choices.
Are you already imagining yourself joining our team? Apply today!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential.
Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.
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