Medical Director, Safety Physician - Oncology

AstraZeneca•Gaithersburg, MD

1d•Onsite

About The Position

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. The position is also 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. The role involves continuous efficient evaluation of adverse event and all other safety information to predict and manage the safety profile of compounds, identify needs for reference safety information updates, and drive proactive risk management initiatives in accordance with global regulatory requirements. It ensures consistent communication of safety topics across all regulatory safety documents (e.g., PBRERs, PADERs, DSURs) for assigned products/programs. The Medical Director proactively evaluates clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other sources to establish the safety profile of compounds, utilizing expert groups and methodologies like Safety Knowledge Groups (SKG’s), Safety Science, Informatics expertise, modeling, and simulation to manage patient risk. The role requires collaborative work with experts across AZ-MedImmune and colleagues from Science Units as a leader/member of Safety Management Teams or other cross-functional project teams, promoting high-quality safety data evaluation. The individual will understand the QPPV role and contribute to pharmacovigilance system maintenance, and support key contacts with opinion leaders as needed.

Requirements

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) with clear evidence of delivery
Drug Development Experience and Application of Disease and TA knowledge
Integrative thinking
Excellence in pharmacovigilance
Patient Benefit risk assessment
Conceptual thinking (associates seemingly unrelated information, analyses situations, takes long term view)
Influencing (presents positive image, demonstrates flexibility, effectively facilitates communication applies negotiation strategies and tactics, to reach conclusion)
Initiative (acts proactively, proposes improvements where appropriate)
Innovation (stays current on emerging trends and new practices within relevant areas)
Business relationship management (demonstrates good knowledge of relevant specialist area, develops strategic and collaborative relationships)

Nice To Haves

UK physicians will generally be expected to have completed Higher Medical Training in Pharmaceutical Medicine
MSc/PhD in scientific discipline
Able to work across TAs and Functions
Experience of supervising Patient Safety colleagues
A demonstrated ability to understand epidemiological data

Responsibilities

Be 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.
Define identified and potential risks with high level mitigation and minimisation; propose mitigation minimisation measures; establish safety go-no go criteria for the clinical programme; provide input to TPP/TPC; develop safety submission strategies; respond to regulatory safety queries and define the risk component of the benefit/risk assessment.
Review and endorse the core Patient Risk Management Plan (PRMP)/Core Patient Risk Log (CPRL).
Provide expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the core PRMP, MedImmune dRMP, CPRL and globally reviewed LRMPs.
Represent PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.
Provide medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.
Provide strategic clinical safety input into Clinical Development planning activities in accordance with PS Operating Model and Science Unit Service Level agreements.
Provide strategic and medical input to project specific safety requirements (PSSR).
Review and provide technical input and approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate.
Provide input on cross-functional ad-hoc teams set up to address urgent and important safety issues.
May present safety information at clinical investigator and commercial meetings.
Facilitate establishment of a Safety Management Team/MedImmune Safety Review Team as necessary.
Be involved in all safety surveillance activities, which may include medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation and SERM activities (or Medimmune equivalent) for all products in area or responsibility.
Provide medical input to regulatory supporting documentation for labelling updates.
Provide medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
Collaborate with external provider representatives in routine signal management activities.
Discuss the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders, eg Patient Safety VP TA, QPPV/Deputy QPPV.
Provide medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Provide strategic input into responses to regulatory requests for local label deviations from the company core safety documentation.
In consultation with the PS scientist and Clinical representatives, prepare the Developmental Core Safety Information (DCSI) for assigned development products.
Provide medical input and review of periodic reports (eg PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies.
Provide the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc) for new products, formulations or indications.
Contribute to and/or review the PS component of Safety Agreements.
Advise on the preparation of licensing agreements in therapeutic area of responsibility.
Participate in AZ internal meetings with project focus.
Participate in external regulatory and non-regulatory meetings including those with consultants and other companies such as licensing partners.
May assist in due diligence activities.
May provide support to AZ Legal for product liability litigation, as appropriate.
Be accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
Participate in, and may lead, a process improvement initiative team within PS.
May contribute to advancement of methodology and process by generating new ideas and proposals for implementation.
Raise concerns/issues to senior management in a timely, open and appropriate manner; ensure quality and integrity of issue/event being escalated.
May mentor and train junior members of the team in signal evaluation methodology, risk management and preparation of safety reports and other documents.
Collaborate effectively in cross-functional and cross-cultural project teams and environments, and work with external providers.

Benefits

qualified retirement program [401(k) plan]
paid vacation
paid holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans
short-term incentive bonus opportunity
eligibility to participate in our equity-based long-term incentive program (salaried roles)

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