Global Safety Head

AstraZeneca•Gaithersburg, MD

16h

About The Position

The Global Safety Head (GSH) is the most senior safety expert reporting to the Global Patient Safety Therapeutic Area (TA) Head Oncology and acts at the disease/strategy area-level for a portfolio of non-clinical, clinical, and marketed assets and is a member to the Franchise Team (if applicable). The Global Safety Head is accountable for all safety aspects of the assigned asset or portfolio of assets in Oncology, as well as the scientific and clinical safety strategies for the Target Product Profile (TPP), Clinical Development Plan (CDP), submissions, core product information, risk management commitments, risk mitigation, including toxicity management, and communication. The GSH also provides safety input into the overall project strategy across the lifecycle. The GSH line manages a team of Global Safety Program Leaders and, if required, safety physicians and / or scientists. You will be responsible for: Clinical Safety Leadership Sets safety goals aligned to TA and asset strategy. Leads the project-specific safety strategy. Contributes to the overall asset strategy. Assures required patient safety quality and compliance in all activities. Manages change through engagement and motivation to and through others. Line manages a team of Global Safety Program Leaders and, if required, safety physicians and / or scientists. Drives staff development and performance in support of AZ products. Coaches individual team members as needed, building future AZ talent through the matrix team model. Accountability and Delivery Single point accountable leader for the safety strategy of the assigned asset(s) throughout their lifecycle to ensure the ethical and scientific integrity of the safety component of plans, studies and products in compliance with AZ policies and GxP. Is accountable for project and/or functional representation of Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings. Under the leadership of a Global Product Leader, is accountable for the scientific and clinical strategies for safety components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), and core labelling. Ensures adequate staffing, resources and capabilities to deliver the global safety strategy for the assigned assets. Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards. As delegated from the Global Patient Safety TA Head responsible for Safety Information Review Committee (SIRC) Chair role and Chairperson consultation for assigned clinical development program(s)/asset(s). Accountable for high quality safety strategic input and Global Patient Safety Position to in-licensing opportunities. Accountable for the risk which contributes to the Benefit/Risk profile of the asset As strategic safety decision maker regarding patient risk, scientific and clinical safety, acts as lead safety representative for the assigned asset(s) in regulatory interactions and interactions with internal senior governance bodies (TALT/ESPC/LSPC/SET). Engagement and consultation with Key External Experts [KEEs]. Establishing and nurturing effective networks. Product teams (Franchise Team and GPT) (if applicable & in addition to above) Safety lead at the Franchise level and at GPT-level. Leads the portfolio-specific safety strategy. Accountable for to the overall safety strategy of the portfolio of clinical development program(s)/asset(s) Accountable for coherence and quality of the asset(s) / indication safety strategies across the portfolio. Accountable for deliverables of the Global Patient Safety function across the portfolio of assets. Single point of contact for senior leaders within Global Patient Safety and other function’s TA-Heads and R&D leaders for safety components of the portfolio of clinical development program(s)/asset(s).

Requirements

Medical degree or equivalent degree in biomedicine or science
Minimum of 8 years or equivalent extensive relevant clinical, safety and risk management experience in the pharmaceutical, biotech, CRO industry, academia or Health Authorities
Direct experience with global regulatory filing and interacting with major regulatory agencies e.g., FDA advisory Committees, Scientific Advice, etc.
Knowledge of relevant pharmacovigilance legislation and GxP requirements.
Thorough knowledge and understanding of safety, including clinical safety, deliverables, standards and processes at a global level; including pre and post launch experience.
Proven track record of successful clinical safety delivery with demonstrated examples of strategic influence to portfolio/clinical studies/programs.
Ability to navigate across a matrixed environment and influence cross-functional senior leaders on decision-making (e.g. Clinical Development, Medical Affairs, Regulatory Affairs).
Sound problem solving skills including the ability to make decisions by developing innovative options and/or multiple solutions to highly complex problems.
Demonstrated ability to successfully lead, coach, and mentor all safety team members.
Proven teamwork and collaboration skills in a global setting.
Strong personal time-management and project-management and organizational skills.
Excellent presentation skills.
Can communicate effectively with internal and external collaborators.
Results-driven leader to drive teams to foster proactive solutions.
Sound judgment to filter information and weigh multiple factors in order to make decisions to ensure the safety of products for patients.
Demonstrated ability to motivate, influence and collaborate with others in a complex global organizational matrix.
Available to travel domestically and internationally
Demonstrated ability to present complex topics to senior leaders at governances for alignment and endorsement.
Knowledge and understanding of US and EU safety regulations pre- and post- marketing.

Nice To Haves

PhD (or other complementary degree) in scientific discipline.
Clinical Development and / or Regulatory and / or Medical Affairs.
Excellent, independent judgment based on leading-edge knowledge and expertise.
Excellent speaking skills, industry conference speaking experience.
Excellent, independent judgment based on knowledge and expertise.
Demonstrated clinical safety and research expertise in an appropriate disease area.

Responsibilities

Sets safety goals aligned to TA and asset strategy.
Leads the project-specific safety strategy.
Contributes to the overall asset strategy.
Assures required patient safety quality and compliance in all activities.
Manages change through engagement and motivation to and through others.
Line manages a team of Global Safety Program Leaders and, if required, safety physicians and / or scientists.
Drives staff development and performance in support of AZ products.
Coaches individual team members as needed, building future AZ talent through the matrix team model.
Single point accountable leader for the safety strategy of the assigned asset(s) throughout their lifecycle to ensure the ethical and scientific integrity of the safety component of plans, studies and products in compliance with AZ policies and GxP.
Is accountable for project and/or functional representation of Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings.
Under the leadership of a Global Product Leader, is accountable for the scientific and clinical strategies for safety components of the Target Product Profile (TPP), Target Product Claim (TPC), Clinical Development Plan (CDP), and core labelling.
Ensures adequate staffing, resources and capabilities to deliver the global safety strategy for the assigned assets.
Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
As delegated from the Global Patient Safety TA Head responsible for Safety Information Review Committee (SIRC) Chair role and Chairperson consultation for assigned clinical development program(s)/asset(s).
Accountable for high quality safety strategic input and Global Patient Safety Position to in-licensing opportunities.
Accountable for the risk which contributes to the Benefit/Risk profile of the asset
As strategic safety decision maker regarding patient risk, scientific and clinical safety, acts as lead safety representative for the assigned asset(s) in regulatory interactions and interactions with internal senior governance bodies (TALT/ESPC/LSPC/SET).
Engagement and consultation with Key External Experts [KEEs].
Establishing and nurturing effective networks.
Safety lead at the Franchise level and at GPT-level.
Leads the portfolio-specific safety strategy.
Accountable for to the overall safety strategy of the portfolio of clinical development program(s)/asset(s)
Accountable for coherence and quality of the asset(s) / indication safety strategies across the portfolio.
Accountable for deliverables of the Global Patient Safety function across the portfolio of assets.
Single point of contact for senior leaders within Global Patient Safety and other function’s TA-Heads and R&D leaders for safety components of the portfolio of clinical development program(s)/asset(s).

Benefits

Benefits offered included 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.

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