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Study Physician - Oncology Late Stage Development

Location Gaithersburg, Maryland, United States Cambridge, England, United Kingdom Job ID R-063047 Date posted 10/09/2019

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity, even in the most difficult situations because we are committed to doing the right thing. We are committed to advancing the science of oncology to deliver life-changing medicines to patients with a pipeline that exploits the power of four scientific platforms (Tumour Drivers and Resistance, DNA Damage Response, Immuno-Oncology, Antibody-Drug Conjugates).We currently have nearly 100 Phase 1, 2, 3 and Lifecycle Management Oncology projects in our robust pipeline.Late-phase Research and Development (R&D) is the science engine room for our late stage development. We transform clinical concepts into medicines that deliver patient health benefits.

This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. We will enable the business to make critical pipeline and investment decisions, to ensure they select the right molecules to progress and to seize the right lifecycle management opportunities. Generating the data required to drive regulatory submissions for new medicines and expanded indications and generating the evidence that shows their value.

As a Study Physician/Indication Lead you will manage global late stage oncology studies (registration-focused). You will focus on the design, conduct, data interpretation and reporting of individual clinical trials, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with Good Clinical Practice (GCP) and regulatory requirements. You have a strong clinical and specialty background in Oncology and will be a peer among the industry, medicine and/or academic community. You will provide expert scientific and clinical input to teams in the Oncology therapeutic area under the direction of the Global Clinical Lead and are responsible for leading all aspects of development of the functional strategy or acting as a renowned expert in own field. You can be based in Cambridge, UK, or Gaithersburg, US.

Main Duties & Responsibilities include:

  • Provides expert knowledge influencing the study design such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements and meets the strategic program objectives.
  • Defines strategies or leads AstraZeneca’s response to complex technical issues for specific medical aspects in relation to current projects, new projects and various plans.
  • Serve as a trial level physician and medical monitor for clinical studies.
  • You will be responsible for protecting the integrity and conduct of clinical studies.
  • Provide consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators.

Essential Requirements:

  • Graduate of a recognized school of medicine with an M.D. degree or equivalent.
  • Specialty training and/or clinical experience and strong academic track record in oncology, Immuno-Oncology, Tumor Immunology, or Immunotherapy.
  • Experience in designing, monitoring and implementing late phase clinical trials and interpreting trial results, including an understanding of biostatistics and safety reporting.
  • Ability to conduct a large study as part of a global team.
  • Ability to function within a matrix environment; to contribute to decision-making and reaching alignment in order to meet challenging timelines.
  • Ability to work collaboratively and to respect other working cultures, including academic partners.
  • Ability to communicate effectively with internal business partners as well as external partners and collaborators; good presentation skills.
  • Understanding of pharmaceutical industry R&D, particularly of major clinical achievements and of the factors which influence those decision points.
  • Ability to work across projects and to foster interactions between teams.
  • Interpersonal skills that influence and shape the image of the organization.
  • Understanding of the interplay between clinical development, lifecycle management, commercial objectives and regulatory requirements.

Desirable Requirements:

  • Specialist / Board Certification in Oncology is preferred.
  • Direct industry drug development experience preferably.
  • Experience with haematological or paediatric malignancies.

Next Steps? Apply now!

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.