Global Safety Head

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 arealevel for a portfolio of nonclinical 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 projectspecific 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 inlicensing 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 GPTlevel.
• Leads the portfoliospecific 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 functions TAHeads and R&D leaders for safety components of the portfolio of clinical development program(s)/asset(s).

You will need to have. The following essential success criteria should be demonstrable at the portfolio level:

• 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 crossfunctional senior leaders on decisionmaking (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 timemanagement and projectmanagement and organizational skills.
• Excellent presentation skills. Can communicate effectively with internal and external collaborators.
• Resultsdriven 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.

We would prefer for you to have:

• PhD (or other complementary degree) in scientific discipline.
• Clinical Development and / or Regulatory and / or Medical Affairs.
• Excellent independent judgment based on leadingedge 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.

The annual base pay (or hourly rate of compensation) for this position ranges from $323216 to $484824. Hourly and salaried nonexempt employees will also be paid overtime pay when working qualifying overtime pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. In addition our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm incentive program (salaried roles)to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). 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. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Date Posted

Closing Date