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Clinical Pharmacology TA Lead Oncology II

Location Gaithersburg, Maryland, United States Gothenburg, Västra Götaland County, Sweden Royston, England, United Kingdom South San Francisco, California, United States Waltham, Massachusetts, United States Job ID R-072121 Date posted 02/23/2020

Clinical Pharmacology TA Lead Oncology II

Clinical Pharmacology & Safety Sciences

All global CPSS locations

Cambridge / Gothenburg / Gaithersburg/ Waltham / South San Francisco

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

The new Clinical Pharmacology & Safety Sciences (CPSS) function will strengthen TA- alignment across clinical pharmacology and safety to improve patient-centric approaches in clinical development. By having a centralised preclinical and clinical bioanalysis and biomarker capability will help maximise speed, efficiency and quality. Bringing together new modalities and biologics expertise under one organisation will maximise discovery, development and regulatory leadership. Building world-class ML/ AI capabilities and systems pharmacology will enable to build an organisation to meet our future innovation needs.

The Oncology Clinical Pharmacology Lead II will be accountable for delivering the Oncology portfolio working in close collaboration with the CPQP Oncology I lead. This individual will be an excellent people leader and line manager of Clinical Pharmacology Scientists and Pharmacometricians. They will have significant expertise in immuno oncology and new modalities associated with Oncology projects such as antibody drug conjugates, cell therapy and viral based therapies. They will be interface with relevant partners and stakeholders in Oncology in addition to all other relevant functions across AstraZeneca.  The Oncology II Lead will represent Clinical Pharmacology on relevant Oncology aligned governance teams as required. They will be accountable for driving  Clinical Pharmacology scientific support and innovation for the Oncology portfolio, specifically in areas of investment such as cell therapy. This individual will be accountable for driving scientific innovation within their team and working closely with the Oncology I team. They will  support the head of CPQP in functional management and strategic initiatives

Responsibilities:

  • Leading a global team supporting the Oncology Portfolio and working seamlessly with the CPQP Oncology I team
  • Delivering on large and small molecule Oncology projects
  • Supporting Oncology filings across a number of different modalities
  • Delivering on all new modality in Oncology specifically cell therapy, viral therapeutics, antibody drug conjugates
  • Accountable for the quality and scientific input into projects and governance
  • Represents the Clinical Pharmacology function in Oncology specific governance
  • Accountable for the review of  clinical pharmacology/pharmacometric elements of regulatory submissions (eg. IND, EoPh II, BLA/NDA  documents and meetings)
  • Joint accountability for any Oncology specific Clinical Pharmacology strategic initiatives
  • Responsible for developing an innovation culture in their group and driving scientific innovation.
  • Supports the Head of Clinical Pharmacology in development of strategy and other functional tasks
  • Accountable for other specific cross functional management aspects dependent on experience
  • Represents Clinical Pharmacology in discussions with key Oncology stakeholders and other departments and ensuring close collaboration with partner functions
  • Manage salary, allocation of bonuses, promotions for team members
  • Championing diversity, inclusion and a culture of life long learning
  • Ensure that the work of the section is performed with the highest quality in accordance with compliance processes

Essential Experience:

  • Significant large and small molecule experience in Oncology with significant immuno oncology experience
  • Experience of oncology filings across a number of different modalities
  • Experience of new modalities in Oncology specifically cell therapy, viral therapeutics, antibody drug conjugates
  • Extensive experience of drug discovery and development
  • A subject matter expert in clinical pharmacology applied to oncology
  • Externally recognised as a key opinion leader in clinical pharmacology applied to oncology
  • Extensive external network and experience of leading and collaborations
  • An extensive publication record in high quality and high impact journals
  • Proven ability to drive scientific innovation in clinical pharmacology in oncology
  • Experience of line management and leadership of skilled professional scientists
  • Experience of setting, implementing and delivering on  strategic initiatives
  • Proven ability to work across regions, functions and cultures



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. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.