Medical Director, Safety Physician - Oncology

About the role

This role is responsible for the Clinical Safety strategy for assigned AstraZeneca-MedImmune 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. Responsible for 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.

Responsibilities

• Responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile of compounds in clinical development and marketed products through identifying the need for update to reference safety information and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements.
• Provides consistent communication of safety topics across all regulatory safety documents, eg Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs) and Development Safety Update Reports (DSURs), for assigned product(s)/program(s).
• Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources in order to predict / establish the safety profile of compounds in clinical development, including employing expert groups and methodologies such as Safety Knowledge Groups (SKG’s), Safety Science, Informatics expertise, modeling and simulation to manage the risk to patients.
• Works collaboratively with experts from across AZ-MedImmune (e.g. Pre-clinical safety, Safety Knowledge Groups, Safety Informatics Scientists and Safety Science), as well as colleagues from all three Science Units as leader/member of a Safety Management Team)/ MedImmune Safety Review Team or as a member of other cross-functional project teams, thereby promoting high quality evaluation of safety data.
• Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes. Supports key contacts with opinion leaders, as needed.

Qualifications

• Medical degree (eg MD, MBBS)
• At least 2 years of clinical experience post-registration
• 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)

Skills

• Leadership (Target level 3)
• Drug Development Experience and Application of Disease and TA knowledge
• Integrative thinking
• Excellence in pharmacovigilance
• Patient Benefit risk assessment

Benefits

The annual base pay for this position ranges from $249,827.20 - $374,740.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered include a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.