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Senior Director, Oncology Patient Safety

Location Gaithersburg, Maryland, United States Job ID R-097379 Date posted 13/10/2021

At AstraZeneca, we deliver life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Crafting a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. Our strategy and ability to transform our medicines portfolio means we have a drug-development pipeline that presents incredible opportunities to push the boundaries of science. Faced with complex disease challenges, we focus on outstanding performance to drive the world’s best and most progressive drug development programs.

Our team is looking for a Senior Director, Oncology Patient Safety to join us in Gaithersburg, US. You will play a pivotal role in channeling our scientific capabilities to make a positive impact on patients' lives. You will help drive development of our innovative pipeline, redefining exciting science into valued new medicines and ensuring patients around the world can access them. You will be representing the voice of patients in the development, maintenance and use of our medicines.

The core purpose of our Patient Safety organization is to add value to AstraZeneca products, provide clear science based guidance for investigators and prescribers to safeguard patients as well as the success of our business.

Our Gaithersburg, Maryland facility creates life-changing medicines for people on a global level. The modern, vibrant scientific campus employs more than 3000 specialists in our field, and it is only a short drive from Washington, DC. It is filled with groundbreaking technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brainstorming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

Main Responsibilities:

You will recruit, develop, and lead a team of pharmacovigilance scientists and staff, and will provide expert oversight of Safety Strategy and Management Team (SSaMT) input to drug programs, and delivery of critical PV outputs. You will apply your expertise to assure quality deliverables, such as Periodic Reports (PBRERs and DSURs), Health Authority queries, PRAC responses, BLA/NDA/MAA filings, Risk Management Plans, etc. As a change management leader, you will lead and implement strategic change projects across Chief Medical Office Patient Safety therapeutic areas.

In addition, you will:

  • Develop objectives for Patient Safety in area of responsibility and ensure these are aligned to broader AstraZeneca goals and objectives.

  • Be an SME for PV regulations/mentorship, leading the Patient Safety Therapy Area

  • Represent and serve as a PV specialist in regulatory agency inspections

  • Share standard methodology across teams within the PS TA and between PS TAs, partnering with other groups as needed

  • Lead PS input into PV Agreements, managing alliance partners for assigned products; may lead due diligence activities

  • Provide strategic safety leadership for complex and ground breaking projects to improve processes within Patient Safety and/or develop and introduce new technologies and approaches at the national, regional or global level

  • Build networks with other PS TAs/teams and external partners to learn about new developments, create opportunities and share best practices, such as benchmarking and Industry forums

  • Partner with PS Center of Excellence to implement changes in PV legislative landscape to prepare appropriate resources and skillsets to address the future

  • Serve as deputy for TA PS VP or Platform Head

  • Participate as a member of the TA Leadership team

Minimum Requirements:

  • Master’s degree or equivalent qualification in relevant scientific field

  • 10+ years of experience

  • Experience in managing a scientific team.

  • Extensive proven experience in Pharmacovigilance field

  • Knowledge of relevant legislation and developments in the Pharmaceutical industry

  • Experience in either writing Risk Management Plans and assessing risk mitigation activities or in translating preclinical safety experience to man

  • Experience leading strategic projects (Drug and non-drug)

  • Demonstrated ability to influence key partners within and outside of company

  • Demonstrated proficiency with both written and verbal communication

Desirable

  • PhD in relevant scientific field

  • Strong network and reputation within the business and industry

  • Extensive knowledge of the latest technical and regulatory expectations

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting



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 authorisation and employment eligibility verification requirements.

10001069 G SCPT R&D Oncology (Susan Galbraith (07016555)) (85008610)

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.