Associate Director, Patient Safety Scientist - Oncology R&D
Job Title: Associate Director, Patient Safety Scientist
Location: Onsite 3 days in Gaithersburg MD
At AstraZeneca,we work togetherto deliver innovative medicines to patientsacross global boundaries. Wemake an impact and findsolutionsto challenges. We do this with integrity, even in the most difficult situations,because we are committed to doing the right thing.
This isanopportunity tofurther develop yourpharmacovigilance (PV)experienceinsafety programmes,spanningthe entire life cycle of drugdevelopmentandperi-/post-submission.Our Scientists and Physiciansplay astrategicrolein developing our medicinesand thesafetyscienceof theprogramme.AstraZeneca’s oncology pipeline,which includesnovel combinations and modalities,provides anintellectual challenge to the safety teams, requiringabroad portfolioand scientificmanagement approach to projects.Ourteams’experience develops as our portfoliodoes.
We are looking for an experiencedAssociate Director, Patient Safety (PS) Scientistto join our Patient Safety department, workingin the Oncology Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientistsand physicians,including coaching junior colleagues. You will playa leading role in delivering the safetystrategy andrequirements for your assigned drug project(s). Yourability to work collaborativelywill facilitatecross-functional interactionswith colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
Asan Associate Director, PS Scientist,you willprovide leadership inaggregating,reviewing,analysingandinterpretingsafety-relateddatatogenerateinformationtosupportsafety decision-making by prescribers, patients and payers, with theultimate goalof protectingpatients.You will apply your strongPV, oncologyand scientificexperience, knowledge and skillsto leadinall aspects ofsafetydocumentation,includingauthoring and / or providingstrategic safety inputtoregulatorydocuments,e.g.,regulatory reports,health authorityresponsesandthesafety content ofmarketing authorisation applications.
Patient Safety sits within the Chief Medical Office, where we have a crucial role to play. This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform ourmedicinesportfolio means we have adrug-developmentpipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines.Faced with complex disease challenges,we focuson exceptional performance to drive the best and most transformative drugdevelopmentprogrammes ever.
Essential Requirements
A Bachelor’s in sciences/pharmacy/nursing degreeor related fieldwith relevant experience or an advance degree with relevant experience
Patient Safety and/or Clinical/Drug Developmentexperience working in or leading safety &/or scientific activities in at least 3 of the following areas:
Clinical drug development (Early and/or Late Phase: develop programme 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)
PeriodicSafetyReports(establish and lead strategy, preparation and authoring)
Risk Management Plans (establish and lead strategy, preparation and authoring)
Governance board interactionsand communicationacross a range of activities
Goodknowledge of PV regulations
Demonstrated ability to handle more than one project simultaneously, prioritizing well and recognizing key issues
Abilitytowork effectively in an advanced matrix structure
Preferred Requirements
MSc/PhD/PharmD in scientific discipline
Advanced understanding of epidemiology
The annual base pay for this position ranges from $122,924 to $184,386. 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?
At AstraZeneca's Oncology R&D business area, you'll be part of a team playing a critical role in driving meaningful change in the way we predict, prevent and treat patients' conditions. We're actively embracing and investing in technology, harnessing digital, data and analytics to reimagine the future of healthcare and deliver improved outcomes to patients beyond core medical. We're shaping the future, improving and speeding up portfolio development, improving the patient experience and outcomes at clinical trials. Join the team that is co-creating a digital ecosystem with patients at its core.
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