Study Physician - Late Oncology - Osimertinib
Late Stage Oncology is the science engine room for our late stage development. 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 transform clinical concepts into medicines that deliver patient health benefits.
In Late Stage Oncology development, we have a crucial role to play. Faced with complex disease challenges, we’re focused on exceptional performance to transform innovative molecules into medicines that change lives. We are responsible for enabling 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 true value.
As a Study Physician - Osimertinib you will manage global or regional studies within the Oncology franchise and will be involved in 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 will have a strong clinical and specialty background in Oncology and will be a peer among the industry, medicine and/or academic community.
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.
- 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 stakeholders as well as external partners and collaborators; good presentation skills.
- Understanding of pharmaceutical industry R&D, particularly of major clinical milestones 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.
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.