Medical Director, Safety Physician - Oncology

AstraZeneca•Gaithersburg, MD

20h•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 Medical Director, Safety Physician is 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 in clinical development and marketed products, identifying the need for updates to reference safety information, and driving proactive implementation of risk management initiatives in accordance with global regulatory requirements. It also entails providing consistent communication of safety topics across all regulatory safety documents (e.g., PBRERs, PADERs, DSURs) and proactively evaluating the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources. The position requires collaborative work with experts across AZ-MedImmune (e.g., Pre-clinical safety, Safety Knowledge Groups, Safety Informatics Scientists, Safety Science) and colleagues from all three Science Units, promoting high-quality evaluation of safety data. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines for some of the world’s most serious diseases. The company strives to be a Great Place to Work, empowering employees to push scientific boundaries, challenge convention, and unleash their entrepreneurial spirit. AstraZeneca is committed to embracing differences and taking bold actions to drive change needed to meet global healthcare and sustainability challenges, fostering an inclusive and equitable environment where diversity fuels innovation.

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
Leadership (Target level 3): Commitment to Customers and Integrity (represents and shapes customer perspectives)
Leadership (Target level 3): Strategic Leadership (identifies untapped opportunities)
Leadership (Target level 3): Acts Decisively (create clarity for others to act decisively)
Leadership (Target level 3): Drives Accountability (creates cross-boundary accountability)
Leadership (Target level 3): Works Collaboratively (establishes shared purpose across boundaries)
Leadership (Target level 3): Develops People and Organisation (invests in long-term development of others)
Technical (Professional level) Drug Development Experience and Application of Disease and TA knowledge
Technical (Professional level) Integrative thinking
Technical (Professional level) Excellence in pharmacovigilance
Technical (Professional level) Patient Benefit risk assessment
Core (Professional level) Conceptual thinking (associates seemingly unrelated information, analyses situations, takes long term view)
Core (Professional level) Influencing (presents positive image, demonstrates flexibility, effectively facilitates communication applies negotiation strategies and tactics, to reach conclusion)
Core (Professional level) Initiative (acts proactively, proposes improvements where appropriate)
Core (Professional level) Innovation (stays current on emerging trends and new practices within relevant areas)
Core (Professional level) 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

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.
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.
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.
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.
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.
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.
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.

Benefits

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)
commission payment eligibility (sales roles)
a qualified retirement program [401(k) plan]
paid vacation
paid holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage

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