Senior Director, Hepatology Safety Center of Excellence at AstraZeneca in Gaithersburg, Maryland

Job Description:

At AstraZeneca we are dedicated to being a Great Place to Work and creating an environment where you are empowered to help push the boundaries of science and unleash your entrepreneurial spirit! There is no better place to make a difference to medicine, patients, and society. We are an inclusive culture that champions diversity and collaboration and we are committed to lifelong learning, growth, and development.


Global Patient Safety at AstraZeneca protects people's health by identifying, predicting, and preventing adverse effects in our medicines. Our team is changing, and we are building a global team passionate about patient safety in the drug development process.


The Hepatic Clinical Safety Knowledge Group (SKG) Lead manages a diverse range of activities related to monitoring, diagnosis, and mitigation of drug/biological-induced organ toxicity in a matrix environment. The role holder encourages, manages, and leads cutting edge drug/biological-induced liver toxicity projects on a global basis. The SKG Lead will be influencing the shaping of the organisation by providing strategic direction and applying a full understanding of global issues related to drug/biological-induced liver toxicity. The role impacts the entire function and the broader AZ organization.


Responsible for managing global or regional therapeutic/ research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. Ensures projects adhere to Good Clinical Practice and regulatory requirements. Will be responsible for overseeing development of the functional strategy or act as renowned expert in own field.




Typical Accountabilities

• Acts as an expert involved in the design, conduct, monitoring, data interpretation and reporting of potential clinical safety signals related to liver toxicity which arise during the conduct of clinical trials.


• Drives scientific research around drug-induced liver injury, having a strong presence at internal and external conferences, and delivering key scientific publications


• Manages global collaborative research projects for state-of-the-art detection, management, and mitigation of clinical safety signals related to organ toxicities


• Ensures the research projects related to drug-induced organ toxicity adhere to Good Clinical Practice and regulatory requirements.


• Acts as renowned expert in liver safety to provide expert scientific and medical input to Patient Safety activities, with special focus on cross-project and cross-TA activities of a scientific nature


• Promotes safety sciences and clinical safety across projects and therapeutic areas


• Leads and contributes to key cross-industry activities around drug-induced liver injury research, such as research consortia


• Contributes to improved understanding and prevention of drug/biological-induced organ toxicity issues across functions within the company and across Pharmaceutical Companies and Regulatory Authorities.


• Lead initiatives to increase cross-company knowledge of drug-induced liver injury through training and other activities


• Expert speaker on drug-induced liver injury at external conferences


• Leads the drug/biological-induced organ toxicity biomarker development and preclinical strategies


• Represents Patient Safety as a Data monitoring committee / safety committee member


• Drives projects to improve visualisation and presentation of liver safety data

Crucial Requirements

• Medical degree with strong clinical experience


• Specialty training and/or board certification in a relevant speciality (e.g. hepatic medicine/surgery, clinical pharmacology)


• 5 years of drug development/safety experience, including a product safety lead role


• Experience in safety data analytics and visualisation of liver safety data (such as through Spotfire or R analytics programmes) including experience of hepatotoxicity signal detection.


• Ability to balance business and clinical research objectives


• Experience working with regulatory agencies, preparing regulatory documents and overseeing submissions.


• A detailed knowledge of the pharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities


• Proven high quality scientific track record

Desirable Skills

• Extensive general medical knowledge and academic/research experience


• Demonstrated capability to lead implementation of new technology and/or working routines within a sophisticated organization.


• Drug development / safety experience across therapeutic areas, including Oncology


• Experience of acting as a Data Monitoring Committee safety representative / experience of setting up a Data monitoring committee


• Proven track record in leading in a cross- industry project or consortia


• Publications in safety-related scientific research


• Strong team-working skills and an ability to work collaboratively in a global pharmaceutical environment


• Strategic thinking


• Strategic influencing

The annual base pay (or hourly rate of compensation) for this position ranges from $265,781 to $398,671. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer 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), 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 "at-will 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.




Why AstraZeneca



With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much yet is still moving forward. There's no better time to join our global, growing enterprise as we lead the way for healthcare and society.




So, what's next



Are you ready to bring new ideas and fresh thinking to the table? Great! We have one seat available, and we hope it's yours.




Where can I find out more



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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Apply Now