Executive Director Patient Safety BioPharma

at  AstraZeneca

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Patient Safety at AstraZeneca is now looking for an Executive Director Patient Safety BioPharma to join our team.
The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca projects and products, provide clear science-based guidance for investigators and prescribers to safeguard patients as well as for the success of our business. Patient Safety covers the entire clinical life cycle of a drug from preparing for first time into man throughout clinical development into postmarketing until divestment/withdrawal of a product from the market.

WHAT YOU’LL DO

The Executive Director position is a global role providing strategic PS input for TA and/or Disease Areas and quality and compliance oversight to a family of drug development and post-marketing programs across life-cycle of substances and products. This includes TPPs, clinical development programs, patient populations, scientific understanding of toxicity-related mechanisms, risk management commitments, risk mitigation and communication.
In this position you will manage a global team of Global Safety Physicians and Patient Safety Scientists including Strategic Safety Management Team Leaders, in order to support PS programs and key initiatives.

YOUR MAIN ACCOUNTABILITIES / RESPONSIBILITIES:

• Provide TA Disease Area strategic PS input to a family of drug development and post-marketing programs across life-cycle of substances and products – e.g to TPPs, , Clinical Development Programs and program-level Go/NoGo, patient populations, scientific understanding of toxicity-related mechanisms, ensure risk management commitments, risk mitigation and communication.
• Drive staff development in support of AZ products
• Ensure that own work and work of team is compliant with Good Clinical and Pharmacovigilance Practice, Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
• Use expertise and knowledge of global issues to recruit and develop strategic Physicians and Scientists objectives for inclusion into business objectives
• Be accountable at Portfolio-level for quality including review of key deliverables (eg RMPsand PSRs), and adherence to PV regulations.
• Define strategies or leads AstraZeneca’s response to complex technical issues for specific safety aspects in relation to current projects, new projects and various plans
• Represent content matter expertise at high level decision-making bodies such as LSPC, SARB, ESB and Development Review Committee on behalf of the relevant PSTAVP
• Be responsible for SIRC Chair role and Chairperson consultation for assigned products
• Work across a number of disease areas in the TA and oversee Safety Physicians, Scientists and SSaMTs working in a portfolio of AZ assets in the TA
• Represent AZ PS in external regulatory meetings
• Influence AZ TA strategies
• Influence the Patient Safety interface with all Clinical Development groups and Regulatory Affairs leads in the TA and with the Commercial organisation
• Review and approve regulatory communication and preparation of higher level documents (eg RMPs, PBRER, DSUR, submission documents)
• Closely follow medical developments within assigned areas and disseminates new information within Patient Safety to transform trends and emerging data into new plans
• Follow important developments and trends in scientific literature and develops contacts with opinion leaders
• Share best practice in PS TA
• Participate in the PSTA BioPharma leadership team

ESSENTIAL FOR THE ROLE

• Medical/clinical/scientific qualification and postgraduate training, or equivalent standards
• 12 years of relevant experience
• Experience in providing strategic leadership to complex drug programs across clinical development phases and into post-marketing.
• Relevant industry experience in Pharmacovigilance field
• Experience in managing a scientific team
• Demonstrated ability to influence key partners within and outside of company
• Demonstrated proficiency with both written and verbal communications

DESIRABLE FOR THE ROLE

• PhD in scientific field
• Extensive general medical knowledge
• Able to work across TAs and Functions
• Research background including peer reviewed publications