Medical Director, Safety Physician - Oncology

Medical Director, Safety Physician - Oncology

Location: Gaithersburg, MD

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.

Role:

• 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.
• The principal accountabilities/responsibilities are summarized below. Safety Governance and Risk Management activities
• Working with the Safety Team, 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. Activities include, but are not limited to: definition of identified and potential risks with high level mitigation and minimisation; proposals for mitigation minimisation measures; safety go-no go criteria for the clinical programme; input to TPP/TPC; s safety submission strategies; response to regulatory safety queries and definition of the risk component of the benefit/risk assessment.
• Reviews and endorses the core Patient Risk Management Plan (PRMP)/Core Patient Risk Log (CPRL).
• Provides 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.
• Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.
• Provides medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.
• Provides strategic clinical safety input into Clinical Development planning activities in accordance with PS Operating Model and Science Unit Service Level agreements.
• Provides strategic and medical input to project specific safety requirements (PSSR). Reviews and provides technical input and approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate.
• Provides 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.
• Facilitates establishment of a Safety Management Team/MedImmune Safety Review Team as necessary. Signal Detection, Evaluation and Labelling Involved in all safety surveillance activities, 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.
• Provides medical input to regulatory supporting documentation for labelling updates.
• Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
• Collaborates with external provider representatives in routine signal management activities.
• Discusses the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders, eg Patient Safety VP TA, QPPV/Deputy QPPV.
• Provides 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.
• Provides 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, prepares the Developmental Core Safety Information (DCSI) for assigned development products. Regulatory Reports and Submissions
• Provides medical input and review of periodic reports (eg PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies.
• Provides the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc) for new products, formulations or indications.
• Other Activities Contributes to and/or reviews the PS component of Safety Agreements Advises on the preparation of licensing agreements in therapeutic area of responsibility.
• Participates in AZ internal meetings with project focus.
• Participates 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 Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
• Participates 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. Raises concerns/issues to senior management in a timely, open and appropriate manner; ensures 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. Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers.
• Requirements Education and Experience Essential

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 NB: It is not mandatory to meet the minimum requirements for length of experience or to have completed the UK Higher Medical Training in Pharmaceutical Medicine; these details are intended to be indicative of the level of knowledge, expertise and recognition required of an individual in this job. Desirable
• 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 Skills and Capabilities Leadership (Target level 3):
• Commitment to Customers and Integrity (represents and shapes customer perspectives)
• Strategic Leadership (identifies untapped opportunities)
• Acts Decisively (create clarity for others to act decisively)
• Drives Accountability (creates cross-boundary accountability)
• Works Collaboratively (establishes shared purpose across boundaries)
• Develops People and Organisation (invests in long-term development of others) Technical (Professional level)
• Drug Development Experience and Application of Disease and TA knowledge
• Integrative thinking
• Excellence in pharmacovigilance
• Patient Benefit risk assessment Core (Professional level)
• 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