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Location:
South San Francisco, California, United States
Gaithersburg, Maryland, United States
Job reference: R-038342
Posted date: Oct. 30, 2018
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  • Job Title: Study Physician – Oncology

    Location: Gaithersburg, United States

    Salary: Competitive salary and benefits package.

    At AstraZeneca, we’re not afraid to do things differently. We’re building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening up new ways to work, pioneering cutting edge methods and bringing unexpected teams together. 

    Global Medicines Development (GMD) 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. There are around 5,000 people in GMD. Our critical, core drug development expertise is at the heart of our three vibrant scientific centers in Gothenburg (Sweden), Cambridge (UK) and Gaithersburg (US).

    In Global Medicines Development (GMD) 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.

    Oncology within GMD has a broad pipeline, offering career development options. As a Study Physician/Indication Lead you will manage global late stage oncology studies (registration-focused) 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. You will provide expert scientific and clinical input to teams in the Oncology therapeutic area under the direction of the Global Clinical Lead and will be responsible for overseeing development of the functional strategy or acting as a renowned expert in own field. 

    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 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. 

    Desirable Requirements:

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

    AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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Study Physician, Oncology
Clinical Development

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