Director, Principal Patient Safety Scientist

Job Title: Director Principal Patient Safety Scientist

Location: Gaithersburg MD (3 days on site)

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 Director, Principal Patient Safety (PS) Scientist to lead the strategy for proactive PV and risk management planning of multiple complex products within the Oncology Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians to shape the culture of the safety team and the wider PSTA function. You will facilitate collaboration with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.

This opportunity will further develop your pharmacovigilance (PV) expertise in safety program, spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists and Physicians play a strategic role in developing our medicines and the safety science of the program. AstraZeneca’s oncology pipeline, which includes novel combinations and modalities, provides an intellectual challenge to the safety teams requiring a broad portfolio and scientific management approach to projects. Our teams’ experience develops as our portfolio does.

Main Responsibilities:

• Provide subject matter expertise and leadership in the therapeutic area and across products.

• Lead the safety surveillance strategy and the presentation of sophisticated safety issues to cross-functional teams and governance committees as well as periodic safety reports and health authority responses.

• Partner with the GSP and other functional specialists to lead the safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA).

• Participate in due diligence activities, negotiating the PV components of contracts/ agreements with third parties to ensure quality and integrity of these documents.

• Provide training and mentorship to other PV Scientists and junior physicians.

Minimum Requirements:

• BS in sciences/pharmacy/nursing or related field

• 7+ years of relevant experience

• Advanced Patient Safety and/or Clinical/Drug Development experience of leading safety &/or scientific activities, across at least 4 of the following areas:

  • Clinical drug development (Early and/or Late Phase: develop program level safety strategy, including proactive risk identification & mitigation planning)

  • Post-Marketing Surveillance (including signal detection & evaluation)

  • MAA/BLA submissions (setting strategy; preparation and authoring of the safety related aspects of the Common Technical Document)

  • Periodic Safety Reports (establish and lead strategy, preparation and authoring)

  • Risk Management Plans (establish and lead strategy, preparation and authoring)

• Governance board interactions and communication across a range of activities

• Advanced knowledge of PV regulations

• Demonstrated ability to handle more than one complex project simultaneously, prioritizing well and recognizing key issues

• Ability to work effectively in an advanced matrix structure

• Proficient in written and verbal English

Desirable

• MS or PhD in relevant scientific field preferred

• 5 additional years of proven experience

• Strong network and reputation within the business and industry

• Extensive knowledge of the latest technical and regulatory expectations

The annual base pay for this position ranges from $177,270 to $265,905. 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. ​

In Office Requirement:

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

So, what’s next:

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you!

Why AstraZeneca?

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.