Medical Director, Patient Safety, Oncology
Location: Gaithersburg, Maryland, Luton, Wilmington, Delaware
Job Type: Full time
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Working with one of the broadest and deepest Oncology pipelines in the industry offers the possibility to work on the most novel molecules at all development stages. It takes each of us challenging our thinking to keep pushing our pipeline forward and shape the future of Oncology.
What you'll do
AstraZeneca’s Patient Safety Physicians, play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca products. You also have a role in shaping the culture of the department, and our senior team members coach and mentor our developing Patient Safety staff. You will play a critical role in ensuring all work is done in accordance with Good Clinical and Pharmacovigilance Practice and regulatory requirements. We encourage you to closely follow medical developments within assigned areas to incorporate emerging data and trends into the safety strategy. In this role, you'll be responsible for the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level. Essentially, the continued safety assessment, evaluation and risk management of AZ products or product groups in various stages of clinical development and/or the post-marketing setting as well as the continuous efficient evaluation of adverse event and all other safety information will be within the remit and scope of this role.
As a Patient Safety Physician your duties and responsibilities may include:
Collaborate with team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings.
Proactively evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature to predict / establish the safety profile of compounds in clinical development.
Ensure expert input to all elements of design and interpretation, including efficient use of tools and methodology (e.g. modelling and simulation).
Provide consistent communication of safety topics across all regulatory safety documents
Senior team members will provide leadership to support project discussions with governance boards, including interactions with Patient Safety Peer Review Committee.
More broadly you are expected to participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external stakeholders.
Essential for the role
Medical degree (e.g. MD, MBBS).
At least 2+ years of clinical experience post-registration, industry experience is preferred
High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
At least 2+ years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery.
Preferred Education, Experience and Skills
MSc/PhD in scientific field
Able to work across TAs and Functions
Experience managing Patient Safety colleagues
A demonstrated ability to understand epidemiological data
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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.